Efficacy and Safety of Fecal Microbiota Transplantation for Clearance of Multidrug-Resistant Organisms under Multiple Comorbidities: A Prospective Comparative Trial.

Fecal microbiota transplantation (FMT) could decolonize multidrug-resistant organisms. We investigated FMT effectiveness and safety in the eradication of carbapenem-resistant Enterobacteriaceae (CRE) and vancomycin-resistant enterococci (VRE) intestinal colonization. A prospective non-randomized comparative study was performed with 48 patients. FMT material (60 g) was obtained from a healthy donor, frozen, and administered via endoscopy. The primary endpoint was 1-month decolonization, and secondary endpoints were 3-month decolonization and adverse events. Microbiota analysis of fecal samples was performed using 16S rRNA sequencing. Intention-to-treat analysis revealed overall negative conversion between the FMT and control groups at 1 (26% vs. 10%, p = 0.264) and 3 (52% vs. 24%, p = 0.049) months. The 1-month and 3-month CRE clearance did not differ significantly by group (36% vs. 10%, p = 0.341; and 71% vs. 30%, p = 0.095, respectively). Among patients with VRE, FMT was ineffective for 1-month or 3-month negative conversion (13% vs. 9%, p > 0.999; and 36% vs. 18%, p = 0.658, respectively) However, cumulative overall negative-conversion rate was significantly higher in the FMT group (p = 0.037). Enterococcus abundance in patients with VRE significantly decreased following FMT. FMT may be effective at decolonizing multidrug-resistant organisms in the intestinal tract.

Prognosis of incompletely resected small rectal neuroendocrine tumor using endoscope without additional treatment.

BACKGROUND: In recent years, the incidence of rectal neuroendocrine tumors (NET)s has markedly increased due to the widespread use of screening colonoscopy. However, many patients are referred from local clinics after undergoing conventional endoscopic mucosal resection (EMR) for polyps without perceived NET, with a pathological report of incomplete resection. We evaluated the prognosis of incompletely resected small rectal NET without additional endoscopic resection for small rectal NET less than 10 mm in diameter present within the submucosal layer showing good prognosis, due to its rare metastatic potential. METHODS: We retrospectively reviewed patients from 2008 to 2018 at a single center who had had small rectal NET (located in the rectum from the anal verge to 20 cm in proximity) and had undergone 'incomplete resection' using endoscopy with a positive deep margin or with a very small safe deep margin (< 100 um). A small rectal NET was defined as a tumor ≤ 10 mm in diameter, without lymph node nor distant metastasis, and with low grade (G1) according to the WHO grading system. RESULTS: Of 267 patients who were diagnosed with small rectal NET, 77 were diagnosed with incomplete resection or possible remnant NET. Of those, 55 patients (55/77, 71.4%) were referred from local clinics post EMR diagnosed as polyps. The rate of histologically incomplete resection was highest in endoscopic submucosal dissection (11/21, 52.4%) and lowest in surgical resection (0/9, 0%), while endoscopic submucosal resection with band ligation showed an incomplete resection rate of 4.4% (5/113). After exclusion of 36 patients, namely 21 patients had undergone additional surgical (n = 6) or endoscopic (n = 15) resection and 25 patients who were lost during the follow-up period of 2 years, 31 patients had undergone surveillance with endoscopic evaluation or either a biopsy or radiological evaluation for distant metastasis during a median follow-up duration of 2 years. None of the incompletely resected small rectal NET patients showed local or distant metastasis. CONCLUSION: Incomplete resection of small rectal NET with G1 grade has a good prognosis without additional treatment.

Hemostatic efficacy and safety of the hemostatic powder UI-EWD in patients with lower gastrointestinal bleeding.

BACKGROUND AND AIMS: Acute lower gastrointestinal bleeding (LGIB) is a common cause of emergency hospitalization and may require readmission for re-bleeding. Recently, a novel endoscopic hemostatic powder (UI-EWD/Nexpowder™, Nextbiomedical, Incheon, South Korea) was developed and applied for the control of LGIB. The aim of this study was to evaluate the hemostatic efficacy and long-term safety of UI-EWD in LGIB. PATIENTS AND METHODS: We conducted a retrospective cohort study of LGIB at a single tertiary center in south Korea. One hundred and sixty-seven consecutive patients with LGIB who were initially successful in endoscopic hemostasis were included and divided into the conventional treatment group (n = 112) and the UI-EWD therapy group (n = 55; 38 patients with conventional treatment and 17 patients with UI-EWD alone). The success rate of hemostasis, adverse events related to UI-EWD, and re-bleeding rate were evaluated. RESULTS: The incidence of endoscopic hemostasis applied to the hepatic flexure (7.3% vs. 0%, p = 0.011) and larger than 4 cm (25.5% vs. 8.0%, p = 0.002) were significantly higher in the UI-EWD group than in the conventional therapy group. The cumulative rebleeding rate within 28 days in the UI-EWD group was 5.5% (3/55), which was significantly lower than that in the conventional treatment group (17.0% [19/112]; p = 0.039). No UI-EWD-related adverse events were recorded. CONCLUSION: Based on our results, application of UI-EWD in LGIB showed promising results for the prevention of re-bleeding, especially in locations where it is difficult to approach or cases with more bleeding. There were no significant complications, such as perforation or embolism. In particular, UI-EWD should be considered first for anatomical or technical impediments to endoscopic access in LGIB.

Bismuth containing quadruple therapy versus tailored therapy as first-line treatments for Helicobacter pylori infection in a high clarithromycin resistance area.

BACKGROUND: Increasing clarithromycin resistance has led to the need for an alternative first-line therapy for the eradication of Helicobacter pylori (H. pylori) in Korea, and bismuth containing quadruple therapy (BQT) and tailored therapy (TT) have been proposed as alternative regimens. The aim of this study was to compare the eradication rates of BQT and TT as first-line H. pylori eradication therapies. METHODS: H. pylori infection was diagnosed using the rapid urease test or dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR) during endoscopy. Patients positive for H. pylori were divided into two groups; those tested using the rapid urease test received empirical BQT (the BQT group) whereas those tested by DPO-PCR received TT (the TT group). Eradication rates, adverse events, and overall medical costs, which included diagnostic test and eradication regimen costs, were compared. RESULTS: Three hundred and sixty patients were included in the study (TT group 178, BQT group 182). The modified intention-to-treat eradication rates of BQT and TT were 88.2% (142/161) and 80.3% (118/147), respectively (p = .055), and corresponding eradication rates in the per-protocol population were 88.8% (142/160) and 81.4% (118/145) (p = .07). Compliance and adverse event rates were similar in the two groups. Average medical costs were $90.3 per patient in the TT group and $75.5 in the BQT group (p = .000). CONCLUSIONS: Empirical BQT and tailored therapy were similar in terms of H. pylori eradication rate, safety, and tolerability, but BQT was more cost-effective.

Efficacy and Safety of Rebamipide versus Its New Formulation, AD-203, in Patients with Erosive Gastritis: A Randomized, Double-Blind, Active Control, Noninferiority, Multicenter, Phase 3 Study.

Background/Aims: : The mucoprotective drug rebamipide is used to treat gastritis and peptic ulcers. We compared the efficacy of MucostaⓇ (rebamipide 100 mg) and its new formulation, AD-203 (rebamipide 150 mg), in treating erosive gastritis. Methods: This double-blind, active control, noninferiority, multicenter, phase 3 clinical trial randomly assigned 475 patients with endoscopically proven erosive gastritis to two groups: AD-203 twice daily or MucostaⓇ thrice daily for 2 weeks. The intention-to-treat (ITT) analysis included 454 patients (AD-203, n=229; MucostaⓇ, n=225), and the per-protocol (PP) analysis included 439 patients (AD-203, n=224; MucostaⓇ, n=215). The posttreatment assessments included the primary (erosion improvement rate) and secondary endpoints (erosion and edema cure rates; improvement rates of redness, hemorrhage, and gastrointestinal symptoms). Drug-related adverse events were evaluated. Results: According to the ITT analysis, the erosion improvement rates (posttreatment) in AD-203-treated and MucostaⓇ-treated patients were 39.7% and 43.8%, respectively. According to the PP analysis, the erosion improvement rates (posttreatment) in AD-203-treated and MucostaⓇ-treated patients were 39.3% and 43.7%, respectively. The one-sided 97.5% lower limit for the improvement rate difference between the study groups was -4.01% (95% confidence interval [CI], -13.09% to 5.06%) in the ITT analysis and -4.44% (95% CI, -13.65% to 4.78%) in the PP analysis. The groups did not significantly differ in the secondary endpoints in either analysis. Twenty-four AD-203-treated and 20 MucostaⓇ-treated patients reported adverse events but no serious adverse drug reactions; both groups presented similar adverse event rates. Conclusions: The new formulation of rebamipide 150 mg (AD-203) twice daily was not inferior to rebamipide 100 mg (MucostaⓇ) thrice daily. Both formulations showed a similar efficacy in treating erosive gastritis.

Percutaneous endoscopic gastrostomy feeding effects in patients with neurogenic dysphagia and recurrent pneumonia.

BACKGROUND: Percutaneous endoscopic gastrostomy (PEG) feeding provides enteral nutrition to patients with neurological dysphagia. However, the conditions in which PEG should be applied to prevent pneumonia remain unclear. We aimed to evaluate the effect of PEG for patients with neurological dysphagia in preventing pneumonia. METHODS: We undertook a retrospective data review of 232 patients with neurological dysphagia who had undergone PEG from January 2008 to December 2018 at Inha University Hospital, in Incheon, Korea. We excluded patients who had not been followed up 6 months pre- and post-PEG feeding. In total, our study comprised 42 patients. We compared pneumonia episodes and incidence pre- and post-PEG. RESULTS: During the median post-PEG follow-up period, the 6-month pneumonia incidence among patients who had undergone PEG had decreased [median 0.3 (interquartile range (IQR) 0.0-0.7) versus 0.1 (IQR 0.1-0.3) episodes, p = 0.04]. In a multiple mixed model, PEG did not decrease the incidence of pneumonia (p = 0.76). However, the association between PEG and the incidence of pneumonia differed significantly depending on the presence or absence of recurrent pneumonia (p < 0.001). CONCLUSIONS: PEG could effectively reduce the incidence of pneumonia in patients with neurogenic dysphagia, especially in those who had experienced recurrent pneumonia.The reviews of this paper are available via the supplemental material section.

Clinical Practice and Guidelines for Managing Antithrombotics before and after Endoscopy: A National Survey Study.

Background/Aims: The proper handling of antithrombotics is critical, and this study aimed to assess guideline adherence in the management of antithrombotics before and after endoscopy. Methods: A survey questionnaire was developed. The respondents' demographic information was included, and the questionnaire was divided into the first section for forceps biopsy, the second for polypectomy, and the third for endoscopic submucosal dissection (ESD) in which aspirin, clopidogrel, combination therapy (aspirin and clopidogrel), warfarin, and direct oral anticoagulants (apixaban) were prescribed to imaginary patients. Results: A total of 415 endoscopists completed this survey (response rate of 6.2%, 415/6,673). The percentage of respondents who chose to proceed with biopsy for patients taking aspirin, those taking clopidogrel, those under combination therapy, those taking warfarin, and those taking apixaban was 89.4%, 74.2%, 61.0%, 38.6%, and 50.4%, respectively. Most respondents answered that they would discontinue aspirin, clopidogrel, and a combination of both drugs for 5 days before polypectomy or ESD (69.4%/76.9%, 83.6%/83.9%, and 53.3%/65.8%, respectively). The answers indicated that warfarin should be discontinued with heparin bridge therapy in high thromboembolic risk patients (polypectomy 70.1%, ESD 73.5%). Regarding apixaban use in polypectomy and ESD, 63.9% and 58.1% of respondents, respectively, chose answers consistent with the guidelines. Conclusions: The gap between the guidelines and clinical practice in the management of antithrombotics before and after endoscopy is considerable and should be addressed via educational strategies.

Effect of scheduled second-look endoscopy on peptic ulcer bleeding: a prospective randomized multicenter trial.

BACKGROUND AND AIM: This study aimed to investigate the effectiveness of scheduled second-look endoscopy (EGD) with endoscopic hemostasis on peptic ulcer rebleeding and to identify the risk factors related to the need for second-look EGD. METHODS: We prospectively randomized patients who had endoscopically confirmed bleeding peptic ulcer with stigmata of active bleeding, visible vessel, or adherent clot into 2 groups between August 2010 and January 2013. Hemoclip application or thermal coagulation and/or epinephrine injection were allowed for initial endoscopic therapy. The same dosage of proton pump inhibitor was injected intravenously. The study group received scheduled second-look EGD 24 to 36 hours after the initial hemostasis, and further therapy was applied if endoscopic stigmata persisted, as above. Those patients who developed rebleeding underwent operation or radiologic intervention despite the additional endoscopic therapy. Outcome measures included rebleeding, amount of transfusion, duration of hospitalization, and mortality. RESULTS: After initial endoscopic hemostasis, 319 eligible patients were randomized into 2 groups. Sixteen (10.1%) and 9 (5.6%) patients developed rebleeding (P = .132), respectively. There was also no difference in surgical intervention (0, 0% vs 1, .6%, P >.999) or radiologic intervention (3, 1.9% vs 2, 1.2%, P = .683), median duration of hospitalization (6.0 vs 5.0 days, P = .151), amount of transfusion (2.4 ± 1.7 vs 2.2 ± 1.6 units, P = .276), and mortality (2, 1.3% vs 2, 1.2%, P > .999) between the 2 groups. Multivariate analysis showed that grades 3 to 4 of endoscopists' estimation to success of initial hemostasis, history of nonsteroidal anti-inflammatory drug (NSAID) use, and larger amounts of blood transfusions (≥4 units of red blood cells) were the independent risk factors of rebleeding. CONCLUSIONS: A single EGD with endoscopic hemostasis is not inferior to scheduled second-look endoscopy in terms of reduction in rebleeding rate of peptic ulcer bleeding. Repeat endoscopy would be helpful in the patients with unsatisfactory initial endoscopic hemostasis, use of NSAIDs, and larger amounts of transfused blood. (Clinical trial registration number: KCT0000565; 4-2010-0348.).

Accuracy of endoscopic ultrasonography for diagnosing ulcerative early gastric cancers.

Although endoscopic ultrasonography (EUS) is the first-choice imaging modality for predicting the invasion depth of early gastric cancer (EGC), the prediction accuracy of EUS is significantly decreased when EGC is combined with ulceration.The aim of present study was to compare the accuracy of EUS and conventional endoscopy (CE) for determining the depth of EGC. In addition, the various clinic-pathologic factors affecting the diagnostic accuracy of EUS, with a particular focus on endoscopic ulcer shapes, were evaluated.We retrospectively reviewed data from 236 consecutive patients with ulcerative EGC. All patients underwent EUS for estimating tumor invasion depth, followed by either curative surgery or endoscopic treatment. The diagnostic accuracy of EUS and CE was evaluated by comparing the final histologic result of resected specimen. The correlation between accuracy of EUS and characteristics of EGC (tumor size, histology, location in stomach, tumor invasion depth, and endoscopic ulcer shapes) was analyzed. Endoscopic ulcer shapes were classified into 3 groups: definite ulcer, superficial ulcer, and ill-defined ulcer.The overall accuracy of EUS and CE for predicting the invasion depth in ulcerative EGC was 68.6% and 55.5%, respectively. Of the 236 patients, 36 patients were classified as definite ulcers, 98 were superficial ulcers, and 102 were ill-defined ulcers, In univariate analysis, EUS accuracy was associated with invasion depth (P = 0.023), tumor size (P = 0.034), and endoscopic ulcer shapes (P = 0.001). In multivariate analysis, there is a significant association between superficial ulcer in CE and EUS accuracy (odds ratio: 2.977; 95% confidence interval: 1.255-7.064; P = 0.013).The accuracy of EUS for determining tumor invasion depth in ulcerative EGC was superior to that of CE. In addition, ulcer shape was an important factor that affected EUS accuracy.

A randomized controlled trial of an educational video to improve quality of bowel preparation for colonoscopy.

BACKGROUND: High-quality bowel preparation is necessary for colonoscopy. A few studies have been conducted to investigate improvement in bowel preparation quality through patient education. However, the effect of patient education on bowel preparation has not been well studied. METHODS: A randomized and prospective study was conducted. All patients received regular instruction for bowel preparation during a pre-colonoscopy visit. Those scheduled for colonoscopy were randomly assigned to view an educational video instruction (video group) on the day before the colonoscopy, or to a non-video (control) group. Qualities of bowel preparation using the Ottawa Bowel Preparation Quality scale (Ottawa score) were compared between the video and non-video groups. In addition, factors associated with poor bowel preparation were investigated. RESULT: A total of 502 patients were randomized, 250 to the video group and 252 to the non-video group. The video group exhibited better bowel preparation (mean Ottawa total score: 3.03 ± 1.9) than the non-video group (4.21 ± 1.9; P < 0.001) and had good bowel preparation for colonoscopy (total Ottawa score <6: 91.6 % vs. 78.5 %; P < 0.001). Multivariate analysis revealed that males (odds ratio [OR] = 1.95, P = 0.029), diabetes mellitus patients (OR = 2.79, P = 0.021), and non-use of visual aids (OR = 3.09, P < 0.001) were associated with poor bowel preparation. In the comparison of the colonoscopic outcomes between groups, the polyp detection rate was not significantly different between video group and non-video group (48/250, 19.2 % vs. 48/252, 19.0 %; P = 0.963), but insertion time was significantly short in video group (5.5 ± 3.2 min) than non-video group (6.1 ± 3.7 min; P = 0.043). CONCLUSION: The addition of an educational video could improve the quality of bowel preparation in comparison with standard preparation method. TRIAL REGISTRATION: Clinical Research Information Service KCT0001836 . The date of registration: March, 08(th), 2016, Retrospectively registered.

Histopathology and TB-PCR kit analysis in differentiating the diagnosis of intestinal tuberculosis and Crohn's disease.

AIM: To compare the histopathologic features of intestinal tuberculosis (ITB) and Crohn's disease (CD) and to identify whether polymerase chain reaction for Mycobacterium tuberculosis (TB-PCR) would be helpful for differential diagnosis between ITB and CD. METHODS: We selected 97 patients with established diagnoses (55 cases of ITB and 42 cases of CD) who underwent colonoscopic biopsies. Microscopic features of ITB and CD were reviewed, and eight pathologic parameters were evaluated. Nine cases of acid fast bacilli culture-positive specimens and 10 normal colonic tissue specimens were evaluated as the positive and negative control of the TB-PCR test, respectively. PCR assays were done using two commercial kits: kit detected IS6110 and MPB64, and kit detected IS6110 only; a manual in-house PCR method was also performed on formalin-fixed, paraffin-embedded colonoscopic biopsy specimens. RESULTS: Statistically significant differences were noted between ITB and CD with regard histopathologic criteria: size of granulomas (P = 0.000), giant cells (P = 0.015), caseation necrosis (P = 0.003), confluent granulomas (P = 0.001), discrete granulomas (P = 0.000), and granulomas with lymphoid cuffs (P = 0.037). However, 29 cases (52.7%) of ITB showed less than five kinds of pathologic parameters, resulting in confusion with CD. The sensitivities and specificities of the TB-PCR test by kit , kit , and the in-house PCR method were 88.9% and 100%, 88.9% and 100%, and 66.7% and 100% in positive and negative controls, respectively. The PCR test done on endoscopic biopsy specimens of ITB and CD were significantly different with kit (P = 0.000) and kit (P = 0.000). The sensitivities and specificities of TB-PCR were 45.5% and 88.1%, 36.4% and 100%, and 5.8% and 100%, for kit and kit and in-house PCR method on endoscopic biopsy specimens. Among the 29 cases of histopathologically confusing CD, 10 cases assayed using kit and 6 cases assayed using kit were TB-PCR positive. A combination of histologic findings and TB-PCR testing led to an increase of diagnostic sensitivity and the increase (from 47.3% to 58.2) was statistically significant with kit (P = 0.000). CONCLUSION: The TB-PCR test combined with histopathologic factors appears to be a helpful technique in formulating the differential diagnosis of ITB and CD in endoscopic biopsy samples.