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1.
Genes (Basel) ; 15(3)2024 03 13.
Article in English | MEDLINE | ID: mdl-38540414

ABSTRACT

POT1 (Protection of Telomeres 1) is a key component of the six-membered shelterin complex that plays a critical role in telomere protection and length regulation. Germline variants in the POT1 gene have been implicated in predisposition to cancer, primarily to melanoma and chronic lymphocytic leukemia (CLL). We report the identification of POT1 p.(I78T), previously ranked with conflicting interpretations of pathogenicity, as a founder pathogenic variant among Ashkenazi Jews (AJs) and describe its unique clinical landscape. A directed database search was conducted for individuals referred for genetic counselling from 2018 to 2023. Demographic, clinical, genetic, and pathological data were collected and analyzed. Eleven carriers, 25 to 67 years old, from ten apparently unrelated families were identified. Carriers had a total of 30 primary malignancies (range 1-6); nine carriers (82%) had recurrent melanoma between the ages of 25 and 63 years, three carriers (27%) had desmoid tumors, three (27%) had papillary thyroid cancer (PTC), and five women (63% of female carriers) had breast cancer between the ages of 44 and 67 years. Additional tumors included CLL; sarcomas; endocrine tumors; prostate, urinary, and colorectal cancers; and colonic polyps. A review of a local exome database yielded an allelic frequency of the variant of 0.06% among all ethnicities and of 0.25% in AJs. A shared haplotype was found in all carriers tested. POT1 p.(I78T) is a founder disease-causing variant associated with early-onset melanoma and additional various solid malignancies with a high tumor burden. We advocate testing for this variant in high-risk patients of AJ descent. The inclusion of POT1 in germline panels for various types of cancer is warranted.


Subject(s)
Leukemia, Lymphocytic, Chronic, B-Cell , Melanoma , Skin Neoplasms , Thyroid Neoplasms , Male , Humans , Female , Adult , Middle Aged , Aged , Melanoma/genetics , Leukemia, Lymphocytic, Chronic, B-Cell/genetics , Telomere-Binding Proteins/genetics , Skin Neoplasms/genetics , Shelterin Complex
2.
Cancers (Basel) ; 16(1)2023 Dec 24.
Article in English | MEDLINE | ID: mdl-38201524

ABSTRACT

Founder pathogenic variants (PVs) are prevalent in Israel. This study investigated the current practice of offering cancer patients two-step genetic testing, starting with targeted testing for recurring founder PVs, followed, if negative, by next-generation sequencing. A total of 2128 subjects with cancer or a positive family history underwent oncogenetic testing with a panel of 51 recurring PVs at a tertiary medical center in March 2020-January 2023. Those with a known familial PV (n = 370) were excluded from the analysis. Among the remainder, 128/1758 (7%) were heterozygous for at least one variant, and 44 (34%) carried a PV of medium-high penetrance (MHPV). Cancer was diagnosed in 1519/1758 patients (86%). The diagnostic yield of founder MHPV testing was 2% in cancer patients and 4% in healthy individuals with a positive family history. It was higher in Ashkenazi Jews than non-Ashkenazi Jews and Arabs, but not over 10% for any type of cancer, and it was significantly higher in younger (<40 years) than older (>50 years) individuals (7% vs. 1%). Eighty-four of the heterozygotes (66%), mostly Ashkenazi Jews, harbored a low-penetrance variant (LPV) not associated with the diagnosed cancer, usually APC c.3902T>A. These findings question the advantage of two-step testing. LPVs should not be included in targeted testing because this can lead to an overestimation of the yield, and their detection does not preclude further comprehensive testing.

3.
Vaccines (Basel) ; 10(3)2022 Feb 28.
Article in English | MEDLINE | ID: mdl-35335008

ABSTRACT

BACKGROUND: Crohn's disease (CD) and ulcerative colitis (UC) are chronic, immune-mediated inflammatory bowel diseases (IBD) affecting millions of people worldwide. IBD therapies, designed for continuous immune suppression, often render patients more susceptible to infections. The effect of the immune suppression on the risk of coronavirus disease-19 (COVID-19) is not fully determined yet. OBJECTIVE: To describe COVID-19 characteristics and outcomes and to evaluate the association between IBD phenotypes, infection outcomes and immunomodulatory therapies. METHODS: In this multi-center study, we prospectively followed IBD patients with proven COVID-19. De-identified data from medical charts were collected including age, gender, IBD type, IBD clinical activity, IBD treatments, comorbidities, symptoms and outcomes of COVID-19. A multivariable regression model was used to examine the effect of immunosuppressant drugs on the risk of infection by COVID-19 and the outcomes. RESULTS: Of 144 IBD patients, 104 (72%) were CD and 40 (28%) were UC. Mean age was 32.2 ± 12.6 years. No mortalities were reported. In total, 94 patients (65.3%) received biologic therapy. Of them, 51 (54%) at escalated doses, 10 (11%) in combination with immunomodulators and 9 (10%) with concomitant corticosteroids. Disease location, behavior and activity did not correlate with the severity of COVID-19. Biologics as monotherapy or with immunomodulators or corticosteroids were not associated with more severe infection. On the contrary, patients receiving biologics had significantly milder infection course (p = 0.001) and were less likely to be hospitalized (p = 0.001). Treatment was postponed in 34.7% of patients until recovery from COVID-19, without consequent exacerbation. CONCLUSION: We did not witness aggravated COVID-19 outcomes in patients with IBD. Patients treated with biologics had a favorable outcome.

4.
Gastrointest Endosc ; 94(6): 1099-1109.e10, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34216598

ABSTRACT

BACKGROUND AND AIMS: Colorectal cancer is a leading cause of death. Colonoscopy is the criterion standard for detection and removal of precancerous lesions and has been shown to reduce mortality. The polyp miss rate during colonoscopies is 22% to 28%. DEEP DEtection of Elusive Polyps (DEEP2) is a new polyp detection system based on deep learning that alerts the operator in real time to the presence and location of polyps. The primary outcome was the performance of DEEP2 on the detection of elusive polyps. METHODS: The DEEP2 system was trained on 3611 hours of colonoscopy videos derived from 2 sources and was validated on a set comprising 1393 hours from a third unrelated source. Ground truth labeling was provided by offline gastroenterologist annotators who were able to watch the video in slow motion and pause and rewind as required. To assess applicability, stability, and user experience and to obtain some preliminary data on performance in a real-life scenario, a preliminary prospective clinical validation study was performed comprising 100 procedures. RESULTS: DEEP2 achieved a sensitivity of 97.1% at 4.6 false alarms per video for all polyps and of 88.5% and 84.9% for polyps in the field of view for less than 5 and 2 seconds, respectively. DEEP2 was able to detect polyps not seen by live real-time endoscopists or offline annotators in an average of .22 polyps per sequence. In the clinical validation study, the system detected an average of .89 additional polyps per procedure. No adverse events occurred. CONCLUSIONS: DEEP2 has a high sensitivity for polyp detection and was effective in increasing the detection of polyps both in colonoscopy videos and in real procedures with a low number of false alarms. (Clinical trial registration number: NCT04693078.).


Subject(s)
Adenomatous Polyps , Colonic Polyps , Colorectal Neoplasms , Artificial Intelligence , Colonic Polyps/diagnosis , Colonoscopy , Colorectal Neoplasms/diagnosis , Humans , Prospective Studies
6.
Harefuah ; 159(4): 251-252, 2020 Apr.
Article in Hebrew | MEDLINE | ID: mdl-32307960

ABSTRACT

INTRODUCTION: Esophageal perforation is a serious disease which entails significant morbidity and mortality. Barogenic perforation (Boerhaave's type perforation) is considered as having a relatively poor prognosis. We present a case of barogenic perforation treated initially with surgery for primary repair leading to the formation of a control fistula. The esophageal fistula was treated successfully with endoscopic vacuum-assisted closure (VAC) system therapy. This case presents a complex condition of esophageal perforation initially treated with surgery for primary repair. After surgery the patient developed a control fistula from the esophagus to the operative drain in the pleural space. We treated the fistula with a VAC (Vacuum Assisted Closure) system that was endoscopically placed in the esophagus at the level of the fistula.


Subject(s)
Esophageal Fistula , Esophageal Perforation , Negative-Pressure Wound Therapy , Drainage , Endoscopy , Humans
7.
United European Gastroenterol J ; 7(6): 735-740, 2019 07.
Article in English | MEDLINE | ID: mdl-31316777

ABSTRACT

Patients with diabetes have distinct risks during precolonoscopy bowel preparation, caused by change of diet, change of antihyperglycemic medication regimens and diabetes-related complications and comorbidities. These risks include hypoglycemia, water and electrolyte imbalance, acute renal failure, lactic acidosis, ketoacidosis and low quality of bowel preparation. Here we review the existing literature and present recommendations from a subcommittee of the Israeli National Diabetes Council for primary care physicians and gastroenterologists. The instructions include general suggestions on diet and glucose monitoring and specific recommendations on timing of modification or cessation of each of the antihyperglycemic medication types to ensure patient safety during bowel preparation.


Subject(s)
Colonoscopy , Hypoglycemic Agents/administration & dosage , Preoperative Care , Blood Glucose , Colonoscopy/adverse effects , Colonoscopy/methods , Diabetes Mellitus/blood , Disease Management , Humans , Hypoglycemic Agents/adverse effects , Practice Guidelines as Topic , Preoperative Period
8.
JNCI Cancer Spectr ; 3(2): pkz024, 2019 Jun.
Article in English | MEDLINE | ID: mdl-31360901

ABSTRACT

BACKGROUND: A fecal test followed by diagnostic colonoscopy for a positive result is a widely endorsed screening strategy for colorectal cancer (CRC). However, the relationship between the time delay from the positive test to the follow-up colonoscopy and CRC mortality has not been established. METHODS: From a population-based screening program, we identified CRC patients newly diagnosed from 2005 through 2015 by a positive fecal occult test followed by a colonoscopy. The primary outcome measure was CRC-specific mortality according to four categories for the time elapsed between the positive result and the subsequent colonoscopy. RESULTS: The 1749 patients underwent colonoscopies within 0-3 months (n = 981, 56.1%), 4-6 months (n = 307, 17.5%), 7-12 months (n = 157, 9.0%), and later than 12 months (n = 304, 17.4%). CRC-specific deaths according to exposure groups were: 13.8% (135 of 981) for 0-3 months, 10.7% (33 of 307) for 4-6 months (crude hazards ratio [HR] = 0.74, 95% confidence interval [CI] = 0.51 to 1.14), 11.5% (18 of 157) for 7-12 months (crude HR = 0.83, 95% CI = 0.51 to 1.42), and 22.7% (69 of 304) for longer than 12 months (crude HR = 1.40, 95% CI = 1.04 to 1.90). The only variable that was associated with mortality risk was the number of positive slides (P = .003). High positivity was twice the value in the 0-3 as the longer-than-12 months group: 51.9% vs 25.0% and similar for the 4-6 and 7-12 months groups (38.1% and 36.5%), respectively. The adjusted HRs for CRC mortality were 0.81 (95% CI = 0.55 to 1.19); 0.83 (95% CI = 0.50 to 1.41), and 1.53 (95% CI = 1.13 to 2.12, P = .006) for the 4-12, 7-12, and longer-than-12-months groups, respectively, compared with the shortest delay group. CONCLUSIONS: Among screen-diagnosed CRC patients, performance of colonoscopy more than 12 months after the initial positive fecal occult blood test was associated with more advanced disease and higher mortality due to CRC.

10.
Inflamm Bowel Dis ; 22(2): 364-71, 2016 Feb.
Article in English | MEDLINE | ID: mdl-26398711

ABSTRACT

BACKGROUND: Systemic inflammation and nutritional deficiencies are characteristics of Crohn's disease (CD) and have been suggested to influence cognitive performance. This study assessed cognitive function in patients with CD. METHODS: Participants were adult patients with CD arriving at routine follow-up. Subjective cognitive complaints, depression, anxiety, fatigue, and sleep were evaluated by validated questionnaires. CD characteristics, blood tests, and Crohn's disease activity index were obtained. Nutritional risk index was derived from serum albumin and change in body weight. Montreal cognitive assessment was used for screening. Patients with either subjective cognitive complaints or Montreal cognitive assessment score ≤ 26 were tested by a computerized cognitive testing battery, with analysis of scores in 7 cognitive domains (CogDs) and an average of the CogD scores-global cognitive score (GCS). Impaired CogD was defined as scoring more than 1 SD below age and education adjusted average. RESULTS: A total of 105 patients were recruited and 61 were tested with computerized cognitive testing battery. Mean age was 39 ± 13 and mean education years were 14 ± 2. The most commonly impaired CogDs were information processing speed (33%) and verbal function (28%). Crohn's disease activity index, nutritional risk index, and hemoglobin were significantly correlated with GCS (r = -0.34, 0.39, 0.33; P = 0.007, 0.003, 0.01). Linear regression revealed significant correlations between Crohn's disease activity index, nutritional risk index, and GCS (ß = -0.3, 0.29; P = 0.03, 0.04), independent of depression. This model explained 24% of the variance in GCS. CONCLUSIONS: Cognitive performance is related to CD activity and nutritional status. The results provide insight into potential influence of nutrition and inflammation on cognitive function. Further studies on cognitive function of patients with CD are warranted.


Subject(s)
Cognition , Crohn Disease/complications , Crohn Disease/physiopathology , Intestinal Diseases/etiology , Nutritional Status , Adolescent , Adult , Aged , Cross-Sectional Studies , Female , Follow-Up Studies , Humans , Intestinal Diseases/pathology , Male , Middle Aged , Prognosis , Surveys and Questionnaires , Young Adult
11.
Endoscopy ; 47(12): 1151-8, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26220283

ABSTRACT

BACKGROUND AND STUDY AIMS: Adenoma miss rate during colonoscopy has become a widely acknowledged proxy measure for post-colonoscopy colorectal cancer. Among other reasons, this can happen because of inadequate visualization of the proximal aspects of colonic folds and flexures. EndoRings (EndoAid Ltd., Caesarea, Israel) is a silicone-rubber device that is fitted onto the distal end of the colonoscope. Its flexible circular rings engage and mechanically stretch colonic folds during withdrawal. The primary aim of this study was to compare adenoma miss rates between standard colonoscopy and colonoscopy using EndoRings. METHODS: In this multicenter, randomized, tandem colonoscopy study, we performed same-day, back-to-back colonoscopies with EndoRings followed by standard colonoscopy, or vice versa. RESULTS: After exclusion of 10 patients for protocol violations, 116 patients (38.8% female; mean age 58.7) remained for analysis. The adenoma miss rate of EndoRings colonoscopy (7/67; 10.4%) was significantly lower (P<0.001) compared with standard colonoscopy (28/58; 48.3%). Similar results were found for polyp miss rates: EndoRings (9.1%) and standard colonoscopy (52.8%; P<0.001). Mean cecal intubation times (9.3 vs. 8.4 minutes; P=0.142) and withdrawal times (7.4 vs. 7.2 minutes; P=0.286), respectively, were not significantly different between EndoRings and standard colonoscopy. Mean total procedure time was longer with EndoRings than with standard colonoscopy (21.6 vs. 18.5 minutes, P=0.001) as more polyps were removed. CONCLUSIONS: This study demonstrates that colonoscopy with EndoRings has lower adenoma and polyp miss rates than standard colonoscopy, which may improve the efficacy particularly of screening and surveillance colonoscopies. ClinicalTrials.gov NCT01955122.


Subject(s)
Adenoma/diagnosis , Colonic Polyps/diagnosis , Colonoscopes , Colonoscopy , Colorectal Neoplasms/prevention & control , Diagnostic Errors , Colonoscopy/instrumentation , Colonoscopy/methods , Colorectal Neoplasms/diagnosis , Comparative Effectiveness Research , Diagnostic Errors/prevention & control , Diagnostic Errors/statistics & numerical data , Female , Humans , Male , Middle Aged , Outcome Assessment, Health Care
12.
Lancet Oncol ; 15(3): 353-60, 2014 Mar.
Article in English | MEDLINE | ID: mdl-24560453

ABSTRACT

BACKGROUND: Although colonoscopy is the accepted standard for detection of colorectal adenomas and cancers, many adenomas and some cancers are missed. To avoid interval colorectal cancer, the adenoma miss rate of colonoscopy needs to be reduced by improvement of colonoscopy technique and imaging capability. We aimed to compare the adenoma miss rates of full-spectrum endoscopy colonoscopy with those of standard forward-viewing colonoscopy. METHODS: We did an international, multicentre, randomised trial at three sites in Israel, one site in the Netherlands, and two sites in the USA between Feb 1, 2012, and March 31, 2013. Patients aged 18-70 years referred for colorectal cancer screening, polyp surveillance, or diagnostic assessment underwent same-day, back-to-back tandem colonoscopy with standard forward-viewing colonoscope and the full-spectrum endoscopy colonoscope. The patients were randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure was done first. The endoscopist was masked to group allocation until immediately before the start of colonoscopy examinations; patients were not masked. The primary endpoint was adenoma miss rates. We did per-protocol analyses. This trial is registered with ClinicalTrials.gov, number NCT01549535. FINDINGS: 197 participants were enrolled. 185 participants were included in the per-protocol analyses: 88 (48%) were randomly assigned to receive standard forward-viewing colonoscopy first, and 97 (52%) to receive full-spectrum endoscopy colonoscopy first. By per-lesion analysis, the adenoma miss rate was significantly lower in patients in the full-spectrum endoscopy group than in those in the standard forward-viewing procedure group: five (7%) of 67 vs 20 (41%) of 49 adenomas were missed (p<0·0001). Standard forward-viewing colonoscopy missed 20 adenomas in 15 patients; of those, three (15%) were advanced adenomas. Full-spectrum endoscopy missed five adenomas in five patients in whom an adenoma had already been detected with first-pass standard forward-viewing colonoscopy; none of these missed adenomas were advanced. One patient was admitted to hospital for colitis detected at colonoscopy, whereas five minor adverse events were reported including vomiting, diarrhoea, cystitis, gastroenteritis, and bleeding. INTERPRETATION: Full-spectrum endoscopy represents a technology advancement for colonoscopy and could improve the efficacy of colorectal cancer screening and surveillance. FUNDING: EndoChoice.


Subject(s)
Adenoma/diagnosis , Colonoscopy/methods , Colorectal Neoplasms/diagnosis , Adolescent , Adult , Aged , Humans , Middle Aged
13.
Endoscopy ; 45(9): 697-702, 2013 Sep.
Article in English | MEDLINE | ID: mdl-23939509

ABSTRACT

BACKGROUND AND STUDY AIMS: Although colonoscopy is the criterion standard for detecting colorectal adenomas and cancers, a significant percentage of adenomas are missed with this technique. We aimed to establish the feasibility, usability, and safety of a novel colonoscopy platform featuring full-spectrum endoscopy (FUSE). PATIENTS AND METHODS: This was a prospective, single-center pilot and feasibility study. In total, 50 individuals, ages 18 - 70 years, underwent colonoscopy featuring FUSE (up to 330° field of view) for colorectal cancer screening, polyp surveillance, or diagnostic evaluation. Study end points included success of cecal intubation, time to cecal intubation, withdrawal time, total procedure time, success of therapeutic interventions, adverse events, and endoscopists' subjective evaluation of FUSE. RESULTS: Cecal intubation was achieved in 50/50 individuals (100 %). Time to cecum (minutes, mean ± SD) was 3.1 ± 1.5 minutes, withdrawal time 12.7 ± 4.4 minutes, and total procedure time 15.3 ± 4.6 minutes. In 22/50 cases (44 %), 26 therapeutic interventions were performed: 19 (73.1 %) biopsies and 7 (26.9 %) polypectomies. No acute or delayed adverse events were observed. Patient satisfaction and endoscopist subjective evaluation were high. CONCLUSIONS: A colonoscopy platform featuring full-spectrum endoscopy appears feasible, usable, and safe. These results represent an important advance in colonoscopy imaging technology and should be further pursued in comparative human studies.


Subject(s)
Adenoma/diagnosis , Cecum , Colonoscopy/instrumentation , Colorectal Neoplasms/diagnosis , Early Detection of Cancer/methods , Intubation , Adenoma/surgery , Adolescent , Adult , Aged , Attitude of Health Personnel , Colonoscopy/adverse effects , Colorectal Neoplasms/surgery , Feasibility Studies , Female , Humans , Male , Middle Aged , Operative Time , Patient Satisfaction , Pilot Projects , Time Factors , Young Adult
14.
Gastrointest Endosc ; 77(3): 472-9, 2013 Mar.
Article in English | MEDLINE | ID: mdl-23410700

ABSTRACT

BACKGROUND: Although colonoscopy is the criterion standard for detecting colorectal adenomas and cancers, a significant percentage of adenomas are missed. OBJECTIVE: To compare forward-viewing with ultrawide-viewing colonoscopy in the detection of simulated colon polyps in an in vitro colon model. DESIGN: Prospective, multicenter. SETTING: Six endoscopy units (3 in the United States and 3 in Israel). PATIENTS: In vitro colon model with simulated colon polyps (n = 21 metallic beads). INTERVENTIONS: Detection of simulated colon polyps on colonoscope withdrawal. MAIN OUTCOME MEASUREMENTS: Incremental detection of simulated colon polyps and endoscopist evaluation of the usability, visibility, and maneuverability of ultrawide-viewing colonoscopy. RESULTS: On forward-viewing colonoscopy, the number of simulated polyps (mean ± standard deviation) detected per endoscopist was 11.1 ± 2.3 polyps, a 52.9% detection rate. Simulated polyp detection rates per colon segment were 3.0 ± 0.93 (60.0%) right colon, 2.4 ± 0.87 (48.0%) transverse colon, and 5.7 ± 1.5 (51.8%) left colon. On ultrawide-viewing colonoscopy, the simulated polyp detection rate per endoscopist significantly increased to 18.0 ± 1.98 polyps, an overall 85.7% polyp detection rate (P < .001). Simulated polyp detection rates were also significantly higher by using the ultrawide-viewing mode in each colon segment, 4.5 ± 0.65 polyps (90.0%) right colon, 4.0 ± 0.87 (80.0%) polyps transverse colon, and 9.6 ± 1.28 polyps (87.3%) left colon (all comparisons, P < .001). Importantly, the ultrawide-viewing mode detected significantly more "hidden" simulated polyps (81.9% vs 31.9%, P < .0001). LIMITATIONS: Nonrandomized design, use of a colon model, and "simulated" colon polyps. CONCLUSIONS: Ultrawide-view colonoscopy significantly improved simulated polyp detection in a colon model. Clinical studies in human subjects should be pursued to further evaluate this new endoscopic technology.


Subject(s)
Colonic Polyps/diagnosis , Colonoscopes , Colonoscopy/methods , Adult , Attitude of Health Personnel , Clinical Competence , Colonoscopy/instrumentation , Female , Humans , Male , Middle Aged , Models, Anatomic , Optical Devices , Prospective Studies
15.
Harefuah ; 150(10): 806-9, 813, 2011 Oct.
Article in Hebrew | MEDLINE | ID: mdl-22111128

ABSTRACT

Capsule endoscopy has been in clinical practice for approximately a decade. The original capsule was designed for the small bowel, followed by esophageal, patency and colonic capsules. The aim of the present guidelines are to update the readers with the mode and preparations for use of the various capsules, the indications, as well as absolute and relative contraindications for their use. This document was written by the advanced technology group within the Israel Gastroenterology Association and was edited by the members of the Israel Gastroenterology Association.


Subject(s)
Capsule Endoscopes , Capsule Endoscopy/methods , Esophageal Diseases/diagnosis , Intestinal Diseases/diagnosis , Colonic Diseases/diagnosis , Colonic Diseases/pathology , Contraindications , Esophageal Diseases/pathology , Humans , Intestinal Diseases/pathology , Intestine, Small/pathology
17.
J Pediatr Gastroenterol Nutr ; 51(5): 618-21, 2010 Nov.
Article in English | MEDLINE | ID: mdl-20808251

ABSTRACT

OBJECTIVES: We compared sedation by propofol combined with either fentanyl or remifentanil in pediatric outpatients undergoing diagnostic esophagogastroduodenoscopy. PATIENTS AND METHODS: Forty-two children scheduled for esophagogastroduodenoscopy in our institution were randomly assigned to receive 2 mg/kg propofol plus either 1 µg/kg bolus of fentanyl (group F; n = 20) or 0.5 µg/kg bolus of remifentanil (group R; n = 22). Cardiorespiratory parameters, sedation level, adverse effects related to the drugs and/or to the procedure, ease of performance for the endoscopist, and time to awakening were analyzed. RESULTS: There were no clinically significant changes in hemodynamics. Apnea periods >20 seconds and decreases in SaO2 <90% occurred more frequently in group R (31.8% vs 0%, P < 0.01, and 27.3% vs 5.0%, P > 0.05, respectively). Children in group R had significantly shorter average time to awakening: 9.5 ± 5.6 vs 16.5 ± 10.5 minutes (P = 0.01), and received a significantly lower total dose of propofol (P = 0.034). Adverse effects within the first 24 hours postprocedure occurred less frequently in group R (P = 0.03). CONCLUSIONS: Remifentanil in combination with propofol provides good analgesic and sedative effects, which were shorter lasting compared with fentanyl-based sedation, and caused fewer delayed adverse effects. The use of remifentanil was associated with respiratory depression, emphasizing the need for experienced anesthesiologists.


Subject(s)
Analgesics, Opioid/therapeutic use , Endoscopy, Digestive System/adverse effects , Fentanyl/therapeutic use , Hypnotics and Sedatives , Piperidines/therapeutic use , Propofol , Analgesics, Opioid/adverse effects , Apnea/etiology , Apnea/prevention & control , Child , Endoscopy, Digestive System/methods , Female , Fentanyl/adverse effects , Hemodynamics/drug effects , Humans , Hypnotics and Sedatives/adverse effects , Hypnotics and Sedatives/therapeutic use , Male , Piperidines/adverse effects , Postoperative Complications/prevention & control , Propofol/adverse effects , Remifentanil , Wakefulness/drug effects
18.
Gastrointest Endosc ; 70(6): 1146-57, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19647245

ABSTRACT

BACKGROUND: Performing a full-thickness intestinal wall resection of a sessile polyp located on the mesenteric side with a compression clip may lead to compression of mesenteric vessels. The application of such a clip may therefore cause a compromised blood supply in the particular bowel segment, leading to perforation. OBJECTIVE: To evaluate the performance of a newly developed, nitinol compression clip, called the NiTi clamp, for full-thickness resection of the bowel wall, while the clip is deliberately deployed endoluminally on the mesenteric side. DESIGN: Prospective animal study. Multinational, multidisciplinary; gastroenterology and general surgery, research cooperation. SETTING: Animal research laboratory. INTERVENTION: Six pigs were operated upon and endoscopically evaluated and then killed after 3 weeks. Linear compression closure clips based on nitinol springs were used. Three longitudinal enterotomies were performed: in the cecum, spiral colon, and proximal rectum. Four clips were deployed in each animal. MAIN OUTCOME MEASUREMENTS: A total of 23 clips were deployed. The average expulsion day was 9 days. RESULTS: All but 3 clips were normally expelled. One pig developed bowel ischemia due to intussusception. In endoscopic procedures, no signs of significant segmental mucosal ischemia were found. The macroscopic appearance of the compression closure lines was thin and delicate, but epithelialization was significantly delayed at 5 sites. LIMITATION: Differences between porcine and human colorectal anatomy. CONCLUSION: Full-thickness clamping of the bowel with the NiTi clamp, including the local mesenteric vasculature, does not significantly impair local healing of the clamp site and gives hope to further development of novel full-thickness endoscopic resection technologies.


Subject(s)
Endoscopy, Gastrointestinal/methods , Intestines/surgery , Surgical Instruments , Animals , Cecum/surgery , Colon/surgery , Equipment Design , Follow-Up Studies , Mesentery , Prospective Studies , Rectum/surgery , Swine
19.
Gastrointest Endosc ; 68(4): 701-10, 2008 Oct.
Article in English | MEDLINE | ID: mdl-18501356

ABSTRACT

BACKGROUND: The Sightline ColonoSight (CS) colonoscopy system presents 3 technologic advances: (1) disposable components protect the reusable parts from contact with colonic contents, eliminating the need for disinfection between procedures, (2) an air-pressure-powered engine assists in colonoscope advancement, (3) light emitting diode (LED) illumination eliminates the need for fiber optics and an external light source. OBJECTIVES: To study the operation, performance, and safety of the Sightline CS colonoscopy system. DESIGN: The system was tested during colonoscopy in animals and in human pilot studies. An in vitro dye diffusion test, and bacterial cultures (obtained after using the colonoscope in animals and humans) were performed to ascertain the protective integrity of the disposable components. SETTING: Animal centers, hospitals in Israel and Italy, and office endoscopy centers in the United States. PATIENTS: Thirty-three volunteers and 145 patients who required a colonoscopy for various indications. INTERVENTIONS: Colonoscopy, polypectomy, biopsy, and coagulation. MAIN OUTCOME MEASURES: Complications, system function, cecal intubation, and colonoscopy time. RESULTS: The Sightline CS system performed well during a colonoscopy in 19 animals and 178 patients, without complications. Dye studies and bacterial cultures showed no transfer of dye molecules or bacterial organisms across the protective, disposable components. LIMITATIONS: This is an observational pilot study, with no comparative group. CONCLUSIONS: The new Sightline CS colonoscopy system performed well. The disposable components eliminated the need for disinfection of the colonoscope between procedures. Advancement of the colonoscope in the colon was helped by self propulsion of the instrument affected by an air-pressure-powered engine. LED illumination eliminated the need for fiber optics and an external light source.


Subject(s)
Colonoscopes , Adolescent , Adult , Aged , Animals , Colonoscopy/methods , Disposable Equipment , Equipment Design , Female , Fiber Optic Technology , Humans , Male , Middle Aged , Pilot Projects , Sheep , Swine
20.
Dig Dis Sci ; 51(11): 1946-51, 2006 Nov.
Article in English | MEDLINE | ID: mdl-17009113

ABSTRACT

The present study determined the acceptability of colonoscopy in outpatients treated with tramadol or fentanyl for analgesia and sedation. One hundred fifty patients were randomly assigned to receive midazolam, 0.05 mg/kg, and fentanyl, 2 microg/kg, intravenously (group 1), midazolam, 0.05 mg/kg, and tramadol, 1 mg/kg, per os (group 2), or midazolam, 0.05 mg/kg, and tramadol, 2 mg/kg, per os (group 3). Pain severity, level of sedation, cardiorespiratory parameters, and procedure-related side effects and complications were registered and analyzed. No significant cardiorespiratory disturbances were observed. Sedation level during the procedure was similar in all groups. Pain severity values measured during the procedure was significantly higher in groups 2 and 3 than in group 1 (P < 0.001). Both hospital and home adverse events occurred more frequently in groups 2 and 3 compared to group 1 (P < 0.03). The patients receiving fentanyl-based analgesia tolerated colonoscopy better than patients treated with tramadol.


Subject(s)
Analgesics, Opioid , Colonoscopy , Conscious Sedation , Fentanyl , Hypnotics and Sedatives , Midazolam , Tramadol , Adult , Aged , Ambulatory Care , Dose-Response Relationship, Drug , Double-Blind Method , Female , Humans , Male , Middle Aged , Pain Measurement , Prospective Studies
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