Efficacy and safety of cholangioscopy guided laser lithotripsy for difficult bile duct stones - A prospective study from a tertiary care centre in Eastern India.

BACKGROUND AND STUDY AIMS: Endoscopic sphincterotomy combined with endoscopic papillary balloon dilatation, mechanical lithotripsy or both, are effective modalities for the ex- traction of difficult common bile duct (CBD) stones. However, approximately 5-15% of cases are still difficult to treat. In the present study, we have evaluated the safety and efficacy of single- operator cholangioscopy guided laser lithotripsy (LL) for difficult to treat CBD stones. PATIENTS AND METHODS: Consecutive patients undergoing LL for the extraction of difficult CBD stones were enrolled in the study. The primary outcomes were related to the efficacy of the procedure in terms of ductal clearance and safety in terms of complications. RESULTS: During the 36 months, 764 patients presented for biliary stone extraction. Most of the patients, 683 (89.4%), had a successful stone extraction with standard techniques. Thirteen patients (1.7%) were not suitable for endoscopic therapy or did not consent for endoscopic therapy, and were referred directly for surgical treatment. Sixty-seven patients (8.8%) were included in the study. Cholangioscope was able to reach the stone in all the cases but one. Complete ductal clearance was achieved in 61 (91%) patients. Complications were encountered in 8 (11.9%) patients. All patients were asymptomatic at one-month of follow-up. CONCLUSION: LL is a highly effective and safe procedure with minimal and transient complications.

Single-balloon enteroscopy in management of small-bowel disorders.

BACKGROUND: Device-assisted enteroscopy including single-balloon enteroscopy (SBE) allows direct visualization of the small bowel and has good safety and efficacy in experienced hands. Our study is aimed to share our single-centre experience of SBE in diagnosing and treating small-bowel disorders. METHODS: We reviewed the prospectively collected data (from December 2016 to December 2019) of 180 consecutive anterograde and/or retrograde procedures. Analysis of baseline characteristics, endoscopic findings, and diagnostic and therapeutic rates was done. RESULTS: SBE was done in 158 patients with a median age of 55 years (range, 13-94 years) for suspected small-bowel lesions. Dual enteroscopy (anterograde plus retrograde) was done in 22 patients (13.92%). The indication for the procedure was obscure gastrointestinal bleeding in 129 (71.66%), chronic unexplained abdominal pain in 20 (11.11%), suspected small-bowel abnormality in the form of narrowing and/or mass on imaging in 10 (5.5%), chronic diarrhea in 9 (5%), unexplained iron deficiency anemia in 9 (5%), and retained capsule in 2 (1.11%). The most common finding was ulcer, which was noted in 45 (25%) patients followed by stricture in 8 (4.44%) and both ulcers and strictures in 6 (3.33%) patients. SBE was normal in 61 (33.88%) patients. SBE gave a diagnosis in 66.11% while in 28.43% cases, therapeutic intervention was done. Minor complications like bleeding were noted in 3 patients and mild acute pancreatitis in 2 patients. Jejunal perforation requiring surgical intervention was noted in 1 patient. CONCLUSION: SBE is a safe and effective procedure in diagnosing and treating small-bowel diseases.

Fluid type and volume reduce risk of post-ERCP pancreatitis and length of hospital stay in high-risk patients: a secondary analysis of the INDIEH trial.

Background and study aims Impact of intravenous fluid administration on prophylaxis against post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) has not been rigorously evaluated among patients at high-risk for PEP. Patients and methods Effect of volume and type of fluid administered on PEP incidence was studied through a secondary analysis of high-risk patients who underwent endoscopic retrograde cholangopancreatography (ERCP) as a part of a randomized controlled trial in which all patients received rectal indomethacin. Periprocedural fluid was defined as fluid infused during and after ERCP. Results A total 960 patients were randomized during the trial, of whom 476 (49.6 %) received periprocedural fluids (mean volume = 1245 mL [±â€Š629]). There was a trend towards a lower incidence of PEP in patients who received periprocedural fluid vs. those who did not (5.2 % vs. 8.0 %, P  = 0.079). Among those receiving fluids, those who did not develop PEP received a higher mean volume of fluid vs. who developed PEP (1012 ±â€Š725 mL vs. 752 ±â€Š783 mL, P  = 0.036). Among 174 patients (37 %) who received LR, patients who did not develop PEP received a higher mean volume of LR vs. those who developed PEP (570 ±â€Š559 mL vs. 329 ±â€Š356 mL, P  = 0.006). Length of hospital stay decreased as the volume of periprocedural volume administration increased (r = 0.16, P  < 0.001). Conclusion Higher fluid volume and lactated Ringer's use during the periprocedural period was associated with a decreased risk of PEP and length of hospital stay beyond rectal indomethacin in high risk patients.

Using single-operator cholangioscopy for endoscopic evaluation of indeterminate biliary strictures: results from a large multinational registry.

BACKGROUND: Peroral cholangioscopy (POCS) of indeterminate biliary strictures aims to achieve a diagnosis through visual examination and/or by obtaining targeted biopsies under direct visualization. In this large, prospective, multinational, real-life experience of POCS-guided evaluation of indeterminate biliary strictures, we evaluated the performance of POCS in this difficult-to-manage patient population. METHODS: This prospective registry enrolled patients, with indeterminate biliary strictures across 20 centers in Asia, the Middle East, and Africa. The primary end points were the ability to visualize the lesion, obtain histological sampling when intended, and an assessment of the diagnostic accuracy of POCS for malignant strictures. Patients were followed for 6 months after POCS or until a definitive malignant diagnosis was made, whichever occurred first. RESULTS: 289 patients underwent 290 POCS procedures with intent to biopsy in 182 cases. The stricture/filling defect was successfully visualized in 286/290 (98.6 %), providing a visual diagnostic impression in 253/290 (87.2 %) and obtaining adequate biopsies in 169/182 (92.9 %). Procedure-related adverse events occurred in 5/289 patients (1.7 %). POCS influenced patient management principally by elucidating filling defects or the causes of bile duct stricture or dilation. The visual impression of malignancy showed 86.7 % sensitivity, 71.2 % specificity, 65.8 % positive and 89.4 % negative predictive value, and 77.2 % overall accuracy compared with final diagnosis. Histological POCS-guided samples showed 75.3 % sensitivity, 100 % specificity, 100 % positive and 77.1 % negative predictive value, and 86.5 % overall accuracy. CONCLUSION: In this large, real-life, prospective series, POCS was demonstrated to be an effective and safe intervention guiding the management of patients with indeterminate biliary strictures.

A study on confocal endomicroscopy in comparison with histopathology for polypoidal lesions of the gastrointestinal tract: A prospective single-centre experience.

BACKGROUND: Confocal laser endomicroscopy (CLE) has a potential to make optical diagnosis of neoplastic polypoidal lesions and may replace traditional histology in the proposed "diagnose and discard approach". The present study was planned to assess the accuracy of probe-based CLE in predicting histology of polypoidal lesions of gastrointestinal (GI) tract in vivo before their removal. METHODS: In this prospective single-centre study, patients with upper and/or lower GI polypoidal lesions were enrolled. After detection of polypoidal lesions with white light endoscopy, probe-based CLE examination was performed. Real-time and offline presumptive CLE diagnosis of polypoidal lesions was made as per Miami classification and was compared with histopathology as the gold standard. RESULTS: A total of 50 GI polyps from 50 patients (28 males) were assessed. The mean (±SD) size of polyps was 13.7 (± 8.5) mm. Most polyps were located at the cecum (24.0%) or stomach (24.0%). On histological examination, hyperplastic and adenomatous polyps, adenocarcinoma, and lipoma were seen in 54%, 26%, 18% and 2% patients, respectively. On comparison of real-time CLE examination with histopathology, 40 (83.3%) and 8 patients (16.7%) had concordant and discordant results, respectively. Two polyps were inconclusively diagnosed on CLE. On offline examination, concordance with histopathology was observed in 85.4% (n = 41) of polyps, which was marginally better than online examination, though the difference was not statistically significant (p = 0.45). On comparing the real-time and offline findings of CLE, concordance was found in 91.7% of the cases. Accuracy, sensitivity, specificity, positive and negative predictive values on real-time evaluation were 83.3%, 87.5%, 79.1%, 80.7%, and 86.3%, respectively. CONCLUSION: CLE is a useful tool for prediction of histology to assess the polypoidal lesions of the GI tract, and it may avoid polypectomy at least in some patients.

An Expert Review and Recommendations on the Rational Use of Proton Pump Inhibitors: Indian Perspective.

BACKGROUND: Proton pump inhibitors (PPIs) are the mainstay of treatment for acid peptic diseases (APDs), but are often irrationally prescribed in clinical practice. Appropriate prescription of PPIs is needed to optimize outcomes, and minimize risks and cost burden on the healthcare system. OBJECTIVE: To review available literature on efficacy and safety of proton pump inhibitors (PPIs) and give recommendations for rational use of PPIs from an Indian perspective. METHODS: Twelve healthcare professionals (9 gastroenterologists, 1 cardiologist, 1 orthopedist, 1 clinical pharmacologist) comprised the expert group; members disclosed conflicts of interest. The creation of the expert review was through a process that included meetings (in-person, online, telephone) where each professional contributed their experiences with regards to efficacy and safety of PPIs. Articles published between the years 2000 and 2017 were reviewed for evaluation of safety and efficacy of PPIs in treatment of various APDs. CONCLUSION: This expert review provides key recommendations for decision making in order to minimize the irrational use of PPIs. Some significant recommendations include: patients with GERD and acid-related complications should take a PPI for minimum 12 weeks for healing of esophagitis, and for maximum up to 48 weeks for symptom control. Patients with Barrett's esophagus should take long-term PPI. Patients at high risk for ulcer-related bleeding from NSAIDs including aspirin should take a PPI if they continue to take NSAIDs. Best practice recommendations are meant to merely assist with decision making in conjunction with patients' clinical history, and are not intended to dictate mandatory rules.

To Evaluate the Efficacy and Effectiveness of N-butyl-2-cyanoacrylate glue (TRU SEAL) in Closure of Oral and Maxillofacial Laceration and Surgical Incisions.

INTRODUCTION: Effective wound closure is critical for minimizing wound complications and preventing wound dehiscence. The various wound closure techniques include staples, traditional nylon and skin sutures, subcuticular sutures, and skin adhesives. Currently topical skin adhesives are frequently being used. It offers countless advantages: short application time, easy execution as well as possessing hemostatic character. N-butyl-2-cyanoacrylate is bacteriostatic and biodegradable and exhibits suitable tensile strength. MATERIALS AND METHODS: Under nasoendotracheal intubation, the reduction in fracture and plating was done. In 80% of the patients, subcutaneous sutures were placed. Skin closure was done with N-butyl-2-cyanoacrylate glue. RESULTS: In this study, REEDA scale was used to assess healing. Redness, edema, and ecchymosis were seen in all 10 patients, which subsided by the second week postoperatively. None of the patients had discharge from surgical site on the first postoperative day but was noted in two patients the first week postoperatively. There was evidence of wound gaping in one patient on the first postoperative day and two patients at end of the first week postoperatively. Stony Brook Scar Evaluation was used to evaluate postoperative cosmesis. No significant cosmetic impairment was found in all patients at the end of the study. CONCLUSION: The study reflects qualitative assessment of cyanoacrylates which is simple to use and proper application which resulted in uniform and everted closure of wound. It is cost-efficient as compared to other wound closure materials.

A Randomized Trial of Topical Epinephrine and Rectal Indomethacin for Preventing Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis in High-Risk Patients.

INTRODUCTION: Rectal indomethacin and topical spray of epinephrine have separately shown efficacy in the prevention of post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP) in randomized controlled trials. We hypothesized that the combination of indomethacin and topical spray of epinephrine on the duodenal papillae would further reduce PEP than when indomethacin was used alone. METHODS: We conducted a comparative effectiveness, multicenter, double-blinded, randomized trial of rectal indomethacin alone vs a combination of rectal indomethacin and topical spray of epinephrine for the prevention of PEP in high-risk patients. The primary outcome was the incidence of PEP and the secondary outcome was the severity of PEP. A 2-tailed Fisher's exact test was used to analyze the difference in the proportion of patients with PEP in the indomethacin alone vs the combination group. RESULTS: A total of 960 patients (mean age 52.33 ± 14.96 years; 551 [57.4%] females) were randomized and 959 completed follow-up. The baseline demographic and clinical characteristics were similar between the 2 groups. Women <50 years of age (25.4%) and difficult cannulation (84.9%) were the most common PEP risk factors. The incidence of PEP was 6.4% in the indomethacin alone group (n = 482) compared to 6.7% in the combination group (n = 477; P = 0.87). Severe PEP was found in 5 (12%) and 7 (16%) patients in the indomethacin alone and combination groups, respectively (P = 0.88). The overall mortality was 0.6%, which was unrelated to the primary outcome. CONCLUSIONS: The combination of rectal indomethacin and topical spray of epinephrine does not reduce the incidence of PEP compared to rectal indomethacin alone in high-risk patients; https://clinicaltrials.gov/ct2/show/NCT02116309.

Mucosal Changes in the Small Intestines in Portal Hypertension: First Study Using the Pillcam SB3 Capsule Endoscopy System.

BACKGROUND/AIMS: To evaluate patients with portal hypertension (PH) of varied etiologies for portal hypertensive enteropathy (PHE) using the PillCam SB3 capsule endoscopy (CE) system. METHODS: Consecutive patients with PH presenting with unexplained anemia and/or occult gastrointestinal bleeding were evaluated using the PillCam SB3 CE system. Abnormal findings were categorized as vascular or non-vascular. The patients with ongoing bleeding caused by PHE were treated. The correlation of the CE scores of PHE with the clinical, laboratory, and endoscopic features was determined. RESULTS: Of the 43 patients included in the study, 41 (95.3%) showed PHE findings. These included varices (67.4%), red spots (60.5%), erythema (44.2%), villous edema (46.5%), telangiectasia (16.3%), and polyps (16.3%). The CE scores varied from 0 to 8 (mean±standard deviation, 4.09±1.8). Five patients (11.6%) showed evidence of ongoing or recent bleeding due to PHE. Three of these five patients underwent endotherapy, and one patient underwent radiological coil placement. CONCLUSION: The PillCam SB3 CE system revealed a high prevalence of PHE in the patients with PH. Using this system, evidence of bleeding due to PHE was found in a small but definite proportion of the patients.

Pancreatic Necrosectomy through Sinus Tract Endoscopy.

BACKGROUND/AIMS: Direct endoscopic pancreatic necrosectomy is increasingly being utilized to treat infected or symptomatic walled-off necrosis (WON) located close to the stomach or duodenum. Laterally-placed WON has traditionally been treated surgically. We evaluated a less utilized technique of sinus tract endoscopy (STE) for symptomatic laterally-placed WON. METHODS: Two hundred seventy-six patients with acute pancreatitis admitted in our hospital, 32 had symptomatic or infected WON requiring intervention. Of the 12 patients with laterally placed WON, 10 were treated by STE. STE was performed with a standard adult gastroscope passed through a percutaneous tract created by the placement of a 32-Fr drain. RESULTS: Ten patients (7 males; mean age, 43.8 years) underwent STE. Mean number of sessions was 2.3 (range, 1-4), with mean time of 70 minutes for each session (range, 15-70 minutes). While 9 patients had complete success, 1 patient had fever and chose to undergo surgery. Two patients developed pneumoperitoneum, which was treated conservatively. There was no mortality, cutaneous fistula, or recurrence during follow-up. CONCLUSIONS: Laterally placed WON can be successfully managed by STE performed through a percutaneously placed drain. Details of the technique and end-points of STE require further evaluation.

Use of self-expanding metal stents for difficult variceal bleed.

BACKGROUND/AIM: Patients with variceal band ligation (VBL)-induced ulcer bleeding and those with persisting bleeding in spite of VBL carry a high mortality. Balloon tamponade and transjugular intrahepatic portosystemic shunt have limitations in terms of complications, cost, and availability. The aim was to evaluate the efficacy of Sx-Ella Danis stent in persistent or complicated variceal bleeding. METHODS: Twelve patients with either persistent variceal bleeding or VBL-induced ulcer bleeding were treated with the placement of Sx-Ella Danis stents. The patients were followed up for mortality, complications, and efficacy to control bleeding. RESULTS: Stents were inserted successfully in all 12 patients (with immediate hemostasis). There was an immediate cessation of bleeding in all 12 patients with no stent-related complication. Five out of 12 patients died during 30 days post-procedure due to worsening encephalopathy or sepsis. Enteral feeding could be started in all 12 patients 6 h after stent placement. One patient had bleeding 10 days after stent removal and was re-stented but expired 7 days later. Stents were removed in eight patients at a mean duration of 17.5 days. (range 7 to 30 days). CONCLUSIONS: Sx-Ella Danis stent is a useful modality to control persistent variceal bleeding as well VBL-related ulcer bleeding.

Endoscopic Management of Gastrointestinal Leaks and Bleeding with the Over-the-Scope Clip: A Prospective Study.

BACKGROUND/AIMS: The over-the-scope clip (OTSC) is a device used for endoscopic closure of perforations, leaks and fistulas, and for endoscopic hemostasis. To evaluate the clinical effectiveness and safety of OTSC. METHODS: Between October 2013 and November 2015, 12 patients underwent OTSC placement by an experienced endoscopist. OTSC was used for the closure of gastrointestinal (GI) leaks and fistula in six patients, three of which were iatrogenic (esophageal, gastric, and duodenal) and three of which were inflammatory. In six patients, OTSC was used for hemostasis of non-variceal upper GI bleeding. Endoscopic tattooing using India ink was used to assist the accurate placement of the clip. RESULTS: All subjects except one with a colonic defect experienced immediate technical success as well as long-term clinical success, during a mean follow-up of 6 weeks. Only one clip was required to close each of the GI defects and to achieve hemostasis in all patients. There were no misfirings or complications of clips. The procedure was well tolerated, and patients were hospitalized for an average of 8 days (range, 3 to 10). Antiplatelet therapy was continued in patients with GI bleeding. CONCLUSIONS: In our experience, OTSC was safe and effective for the closure of GI defect and to achieve hemostasis of non-variceal GI bleeding.

Burdick's Technique for Biliary Access Revisited.

The precut sphincterotomy is used to facilitate selective biliary access in cases of difficult biliary cannulation. Needle-knife precut papillotomy is the standard of care but is associated with a high rate of complications such as pancreatitis, duodenal perforation, bleeding, etc. Sometimes during bowing of the sphincterotome/cannula and the use of guide wire to facilitate biliary cannulation, inadvertent formation of a false passage occurs in the 10 to 11 o'clock direction. Use of this step to access the bile duct by the intramucosal incision technique was first described by Burdick et al., and since then two more studies have also substantiated the safety and efficacy of this non-needle type of precut sphincterotomy. In this review, we discuss this non-needle technique of precut sphincterotomy and also share our experience using this "Burdick's technique."

How useful are medication patient information leaflets to older adults? A content, readability and layout analysis.

BACKGROUND: Patient information leaflets (PILs) are the most important information source for older patients to effectively manage their drug therapy. OBJECTIVE: The objective of this study is to evaluate the appropriateness of current available PILs for use by older adults. METHODS: The content of the PILs were assessed by checking the availability of information relevant to older patients including pharmacokinetics, safety and dose instructions. The layout of the PILs was evaluated using criteria derived from the relevant regulatory guidelines on the design of PILs. The Gunning Fog Index was used to determine the readability of the PILs to older adults. RESULTS: Total of 48 PILs were analysed involving 25 drug substances for the treatment of cardiovascular disease and type 2 diabetes. One out of the 48 PILs contained information on pharmacokinetic changes in older patients and only 15 % of the PILs specified the age of the older person. Thirty-one percent of the PILs provided nonspecific warnings to the older population, while only 15 % included specific side effects that could occur in the older generation. Text font sizes of the PILs were generally too small for older adults to read, with only 9 % of the PILs used type size 12 or over. The readability of 63 % of the PILs had a score above 12, which is considered difficult for older people to understand. CONCLUSION: Currently available medication PILs are inappropriate for use by older adults to manage their medications effectively, which could adversely affect patient safety and adherence to drug therapy.

A clinical trial to evaluate the safety and immunogenicity of the LEISH-F1+MPL-SE vaccine for use in the prevention of visceral leishmaniasis.

Healthy Indian adult volunteers, with or without a history of leishmaniasis, were evaluated for evidence of previous infection with Leishmania donovani based on the direct agglutination test (DAT). Three cohorts of 6 DAT-negative and 6 DAT-positive subjects were enrolled in an open-label, dose-escalating, uncontrolled clinical trial and received three injections of the LEISH-F1+MPL-SE vaccine (consisting of 5µg, 10µg, or 20µg recombinant Leishmania polyprotein LEISH-F1 antigen+25µg MPL®-SE adjuvant). The study injections were given subcutaneously on days 0, 28, and 56, and the subjects were followed through day 168 for safety and immunological endpoints. The vaccine was safe and well-tolerated in DAT-negative and DAT-positive subjects and induced T-cell production of IFN-γ and other cytokines in response to stimulation with the LEISH-F1 antigen. This clinical trial shows that the LEISH-F1+MPL-SE vaccine is safe and immunogenic in healthy subjects with and without history of previous infection with Leishmania donovani.