Impact of withdrawal time on adenoma detection rate: results from a prospective multicenter trial.

BACKGROUND AND AIMS: Performing a high-quality colonoscopy is critical for optimizing the adenoma detection rate (ADR). Colonoscopy withdrawal time (a surrogate measure) of ≥6 minutes is recommended; however, a threshold of a high-quality withdrawal and its impact on ADR are not known. METHODS: We examined withdrawal time (excluding polyp resection and bowel cleaning time) of subjects undergoing screening and/or surveillance colonoscopy in a prospective, multicenter, randomized controlled trial. We examined the relationship of withdrawal time in 1-minute increments on ADR and reported odds ratio (OR) with 95% confidence intervals. Linear regression analysis was performed to assess the maximal inspection time threshold that impacts the ADR. RESULTS: A total of 1142 subjects (age, 62.3 ± 8.9 years; 80.5% men) underwent screening (45.9%) or surveillance (53.6%) colonoscopy. The screening group had a median withdrawal time of 9.0 minutes (interquartile range [IQR], 3.3) with an ADR of 49.6%, whereas the surveillance group had a median withdrawal time of 9.3 minutes (IQR, 4.3) with an ADR of 63.9%. ADR correspondingly increased for a withdrawal time of 6 minutes to 13 minutes, beyond which ADR did not increase (50.4% vs 76.6%, P < .01). For every 1-minute increase in withdrawal time, there was 6% higher odds of detecting an additional subject with an adenoma (OR, 1.06; 95% confidence interval, 1.02-1.10; P = .004). CONCLUSIONS: Results from this multicenter, randomized controlled trial underscore the importance of a high-quality examination and efforts required to achieve this with an incremental yield in ADR based on withdrawal time. (Clinical trial registration number: NCT03952611.).

High-Definition Colonoscopy Compared With Cuff- and Cap-Assisted Colonoscopy: Results From a Multicenter, Prospective, Randomized Controlled Trial.

BACKGROUND AND AIMS: Mucosal exposure devices including distal attachments such as the cuff and cap have shown variable results in improving adenoma detection rate (ADR) compared with high-definition white light colonoscopy (HDWLE). METHODS: We performed a prospective, multicenter randomized controlled trial in patients undergoing screening or surveillance colonoscopy comparing HDWLE to 2 different types of distal attachments: cuff (CF) (Endocuff Vision) or cap (CP) (Reveal). The primary outcome was ADR. Secondary outcomes included adenomas per colonoscopy, advanced adenoma and sessile serrated lesion detection rate, right-sided ADR, withdrawal time, and adverse events. Continuous variables were compared using Student's t test and categorical variables were compared using chi-square or Fisher's exact test using statistical software Stata version16. A P value <.05 was considered significant. RESULTS: A total of 1203 subjects were randomized to either HDWLE (n = 384; mean 62 years of age; 81.3% males), CF (n = 379; mean 62.7 years of age; 79.9% males) or CP (n = 379; mean age 62.1 years of age; 80.5% males). No significant differences were found among 3 groups for ADR (57.3%, 59.1%, and 55.7%; P = .6), adenomas per colonoscopy (1.4 ± 1.9, 1.6 ± 2.4, and 1.4 ± 2; P = .3), advanced adenoma (7.6%, 9.2%, and 8.2%; P = .7), sessile serrated lesion (6.8%, 6.3%, and 5.5%; P = .8), or right ADR (48.2%, 49.3%, and 46.2%; P = .7). The number of polyps per colonoscopy were significantly higher in the CF group compared with HDWLE and CP group (2.7 ± 3.4, 2.3 ± 2.5, and 2.2 ± 2.3; P = .013). In a multivariable model, after adjusting for age, sex, body mass index, withdrawal time, and Boston Bowel Preparation Scale score, there was no impact of device type on the primary outcome of ADR (P = .77). In screening patients, CF resulted in more neoplasms per colonoscopy (CF: 1.7 ± 2.6, HDWLE: 1.3 ± 1.7, and CP: 1.2 ± 1.8; P = .047) with a shorter withdrawal time. CONCLUSIONS: Results from this multicenter randomized controlled trial do not show any significant benefit of using either distal attachment devices (CF or CP) over HDWLE, at least in high-detector endoscopists. The Endocuff may have an advantage in the screening population. (ClinicalTrials.gov, Number: NCT03952611).

Impact of a ring-fitted cap on insertion time and adenoma detection: a randomized controlled trial.

BACKGROUND AND AIMS: Devices for flattening colon folds can improve polyp detection at colonoscopy. However, there are few data on the endoscopic ring-fitted cap (EndoRings; EndoAid, Caesarea, Israel). We sought to compare adenoma detection with EndoRings with that of standard high-definition colonoscopy. METHODS: This was a single-center, randomized controlled trial of 562 patients (284 randomized to EndoRings and 278 to standard colonoscopy) at 2 outpatient endoscopy units in the Indiana University Hospital system. Adenoma detection was the primary outcome measured as adenoma detection rate (ADR) and adenomas per colonoscopy (APC). We also compared sessile serrated polyp detection rate, insertion times, withdrawal times, and ease of passage through the sigmoid colon. RESULTS: EndoRings was superior to standard colonoscopy in terms of APC (1.46 vs 1.06, P = .025), but there were no statistically significant differences in ADR or sessile serrated polyp detection rate. Mean withdrawal time (in patients with no polyps) was shorter and insertion time (all patients) was longer in the EndoRings arm by 1.8 minutes and 0.75 minutes, respectively. One provider had significantly higher detection with Endo-Rings and contributed substantially to the overall results. CONCLUSIONS: EndoRings can increase adenoma detection without a significant increase in procedure time, but the effect varies between operators. The use of EndoRings slows colonoscope insertion. (Clinical trial registration number: NCT03418662.).

A comparison of 2 distal attachment mucosal exposure devices: a noninferiority randomized controlled trial.

BACKGROUND AND AIMS: Endocuff (Arc Medical Design, Leeds, UK) and Endocuff Vision (Arc Medical Design, Leeds, UK) are effective mucosal exposure devices for improving polyp detection during colonoscopy. AmplifEYE (Medivators Inc, Minneapolis, Minn, USA) is a device that appears similar to the Endocuff devices but has received minimal clinical testing. METHODS: We performed a randomized controlled clinical trial using a noninferiority design to compare Endocuff Vision with AmplifEYE. RESULTS: The primary endpoint of adenomas per colonoscopy was similar in AmplifEYE at 1.63 (standard deviation 2.83) versus 1.51 (2.29) with Endocuff Vision (P = .535). The 95% lower confidence limit was 0.88 for ratio of means, establishing noninferiority of AmplifEYE (P = .008). There was no difference between the arms for mean insertion time, and mean inspection time (withdrawal time minus polypectomy time and time for washing and suctioning) was shorter with AmplifEYE (6.8 minutes vs 6.9 minutes, P = .042). CONCLUSIONS: AmplifEYE is noninferior to Endocuff Vision for adenoma detection. The decision on which device to use can be based on cost. Additional comparisons of AmplifEYE with Endocuff by other investigators are warranted. (Clinical trial registration number: NCT03560128.).

Correction to: Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Low Dose.

The original version of the article unfortunately contained an error in article title. The corrected title is 'Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Low Dose'.

Fecal Microbiota Transplantation Capsules with Targeted Colonic Versus Gastric Delivery in Recurrent Clostridium difficile Infection: A Comparative Cohort Analysis of High and Lose Dose.

BACKGROUND: Fecal microbiota transplantation (FMT) is an effective therapy for recurrent Clostridium. difficile infection (rCDI). FMT capsules have emerged, and it is unknown if delivery location and dose impact efficacy. METHODS: We compared two cohorts of patients receiving two capsule formulations: gastric release (FMTgr) and targeted colonic release (FMTcr) at two different sites. Cohort A received FMTgr at (1) high dose: 60 capsules and low dose: 30 capsules. Patients in Cohort B received FMTcr at (1) high dose: 30 capsules (2) low dose: 10 capsules. Clinical cure rates and adverse events were monitored through week 8. Paired t-tests were used to compare diversity pre- and post-FMT. RESULTS: 51 rCDI patients were enrolled. Cohort A contained n = 20 and Cohort B contained n = 31. Overall cure at week 8 for FMTgr was 75% (15/20) compared to 80.6% for FMTcr, (25/31), p = 0.63. Both formulations were safe with no serious adverse events. FMTcr was superior at increasing gut microbial diversity. DISCUSSION: To our knowledge, this is the first study to compare targeted delivery of FMT capsules. While both capsules were safe and efficacious, microbial engraftment patterns were superior in FMTcr.

Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial.

BACKGROUND: The value of narrow-band imaging (NBI) for detecting serrated lesions is unknown. OBJECTIVE: To assess NBI for the detection of proximal colon serrated lesions. DESIGN: Randomized, controlled trial. SETTING: Two academic hospital outpatient units. PATIENTS: Eight hundred outpatients 50 years of age and older with intact colons undergoing routine screening, surveillance, or diagnostic examinations. INTERVENTIONS: Randomization to colon inspection in NBI versus white-light colonoscopy. MAIN OUTCOME MEASUREMENTS: The number of serrated lesions (sessile serrated polyps plus hyperplastic polyps) proximal to the sigmoid colon. RESULTS: The mean inspection times for the whole colon and proximal colon were the same for the NBI and white-light groups. There were 204 proximal colon lesions in the NBI group and 158 in the white light group (P = .085). Detection of conventional adenomas was comparable in the 2 groups. LIMITATIONS: Lack of blinding, endoscopic estimation of polyp location. CONCLUSION: NBI may increase the detection of proximal colon serrated lesions, but the result in this trial did not reach significance. Additional study of this issue is warranted. ( CLINICAL TRIAL REGISTRATION NUMBER: NCT01572428.).

Association of greater intravenous volume infusion with shorter hospitalization for patients with post-ERCP pancreatitis.

BACKGROUND AND AIM: There are no data specifically correlating early intravenous volume infusion (IVI) with the length of hospitalization for postendoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). METHODS: We conducted a retrospective cohort study of patients admitted within 24 h after ERCP to our institute with PEP. IVI during the first 24 h after ERCP was assessed. Primary outcome was severity of PEP, defined by length of hospitalization according to consensus guidelines: mild ≤ 3, moderate 4-10, and severe > 10 days. RESULTS: Of 72 eligible patients, 41 (56.9%) had mild and 31 (43.1%) moderate/severe PEP. Both groups had comparable demographics, indications, and procedural factors except patients with moderate/severe PEP were older (median age 49 vs 36 years, P = 0.05) and more likely to be discharged and readmitted within the first 24 h (41.9% vs 14.6%, P < 0.01). Patients with mild PEP received significantly greater IVI during the first 24 h (2834 mL [2046, 3570] vs 2044 mL [1227, 2875], P < 0.02) and 50% more fluid post-ERCP (2270 mL [1435, 2961] vs 1515 [950-2350], P < 0.02) compared with those with at least moderate PEP. CONCLUSION: In patients with PEP, greater IVI during the first 24 h after ERCP is associated with reduced length of hospitalization. Lower IVI was more commonly observed in individuals who were discharged and then readmitted during the first 24 h.

Ruptured idiopathic hepatic artery pseudoaneurysm causing portal vein thrombosis with portal hypertension and variceal bleeding.

Portal vein thrombosis (PVT) is an important cause of noncirrhotic portal hypertension. Noncancerous extrinsic compression of portal vein to drive PVT formation is rare, but important to identify. A 64-year-old female with idiopathic hepatic artery pseudoaneurysm (HAPA) rupture 7 months prior presented with acute-onset hematemesis and melena and was found to have prehepatic portal hypertensive variceal bleeding. Her HAPA-related retroperitoneal hematoma had resulted in portal vein compression, thrombosis, and cavernous transformation despite prompt stent graft placement across the ruptured HAPA, and required definitive treatment by transjugular intrahepatic portosystemic shunt creation with portal vein reconstruction utilizing a trans-splenic access. This case highlights the importance of interval abdominal imaging and hypercoagulability screening for noncirrhotic patients at-risk for PVT, which identified the patient as a heterozygous carrier of Factor V Leiden.

Inflammatory Bowel Disease Outcomes Following Fecal Microbiota Transplantation for Recurrent C. difficile Infection.

BACKGROUND: Recurrent Clostridioides difficile infection (CDI) in patients with inflammatory bowel disease (IBD) is a clinical challenge. Fecal microbiota transplantation (FMT) has emerged as a recurrent CDI therapy. Anecdotal concerns exist regarding worsening of IBD activity; however, prospective data among IBD patients are limited. METHODS: Secondary analysis from an open-label, prospective, multicenter cohort study among IBD patients with 2 or more CDI episodes was performed. Participants underwent a single FMT by colonoscopy (250 mL, healthy universal donor). Secondary IBD-related outcomes included rate of de novo IBD flares, worsening IBD, and IBD improvement-all based on Mayo or Harvey-Bradshaw index (HBI) scores. Stool samples were collected for microbiome and targeted metabolomic profiling. RESULTS: Fifty patients enrolled in the study, among which 15 had Crohn's disease (mean HBI, 5.8 ± 3.4) and 35 had ulcerative colitis (mean partial Mayo score, 4.2 ± 2.1). Overall, 49 patients received treatment. Among the Crohn's disease cohort, 73.3% (11 of 15) had IBD improvement, and 4 (26.6%) had no disease activity change. Among the ulcerative colitis cohort, 62% (22 of 34) had IBD improvement, 29.4% (11 of 34) had no change, and 4% (1 of 34) experienced a de novo flare. Alpha diversity significantly increased post-FMT, and ulcerative colitis patients became more similar to the donor than Crohn's disease patients (P = 0.04). CONCLUSION: This prospective trial assessing FMT in IBD-CDI patients suggests IBD outcomes are better than reported in retrospective studies.

Terlipressin therapy for reversal of type 1 hepatorenal syndrome: a meta-analysis of randomized controlled trials.

BACKGROUND AND AIM: Hepatorenal syndrome (HRS) is a serious complication of advanced liver disease and carries a poor prognosis. Recent trials have indicated that terlipressin may be effective in reversing HRS. Our aim was to evaluate the efficacy of terlipressin therapy in reversing type 1 HRS defined as a serum creatinine <1.5 mg/dL during treatment. METHODS: Randomized controlled trials in which patients with type 1 HRS received at least 3 days of terlipressin therapy and albumin in the intervention arm were included after a systematic search of the published English reports. Studies with other vasoconstrictor therapies in the control group were excluded. RESULTS: A total of 223 patients with HRS type 1 in four different trials, were included in the final analysis. Alcohol-related cirrhosis was the most common underlying etiology. The risk ratio for reversal in type 1 HRS with terlipressin therapy was 3.66 (95% confidence interval 2.15-6.23). Recurrence of HRS was low (8%). Serious side-effects requiring discontinuation of therapy were seen only in 6.8% of patients on terlipressin therapy. There was a trend towards improved transplant-free survival at 90 days in the terlipressin group (relative risk 1.86 95% confidence interval 1.0-3.4, P = 0.05). CONCLUSIONS: Terlipressin is effective in reversing HRS type 1. Recurrence of HRS is rare with at least 14 days of therapy. Serious side-effects requiring discontinuation of therapy are less common. There appears to be a survival benefit in patients with HRS treated with terlipressin.

Bannayan Ruvalcaba Riley Syndrome.

A 63-year-old male with history of prostate cancer treated with radiation presented for a colonoscopy for small volume hematochezia. The colonoscopy revealed numerous polyps, which were found to be ganglioneuromas on histological examination. He was referred to medical genetics with suspicion for hamartomatous polyposis syndrome and was found to have a mutation in the PTEN gene. Based on this and suggestive clinical findings, he was diagnosed with Bannayan Ruvalcaba Riley syndrome.

Early measures of hemoconcentration and inflammation are predictive of prolonged hospitalization from post- endoscopic retrograde cholangiopancreatography pancreatitis.

OBJECTIVES: Hemoconcentration markers are predictors of severe acute pancreatitis but have not been specifically evaluated in post-endoscopic retrograde cholangiopancreatography pancreatitis (PEP). METHODS: Case-control study of patients undergoing ERCP for suspected sphincter of Oddi dysfunction. We identified patients with PEP (PEP positive) and controls (PEP negative) in a 1:2 ratio. blood urea nitrogen (BUN) and hematocrit (Hct) were measured before procedure, upon admission, and 24 hours later. Preprocedure levels of BUN and Hct were analyzed to control for confounders. Among the PEP-positive patients, BUN level, Hct level, and systemic inflammatory response syndrome are compared between severe and mild/moderate cases. RESULTS: There were 149 PEP-positive patients, including 18 patients (12.1%) with severe PEP and 301 PEP-negative controls. After adjusting, higher preprocedure BUN level (odds ratio [OR], 1.05 [1.01, 1.10]; P < 0.02) and pancreatic sphincterotomy (OR, 1.60 [1.01, 2.55]; P < 0.05) were associated with PEP, whereas older age (OR, 0.98 [0.96, 0.99]; P < 0.02) and a greater body mass index (OR, 0.97 [0.94, 0.99]; P < 0.03) with a lower rate.Difference in BUN level of 0.0 or greater (failure to decline) had a sensitivity of 71% and a specificity of 79% for differentiating severe from mild/moderate PEP. Patients with severe PEP were more likely to have systemic inflammatory response syndrome upon admission (44.4% [21.5, 67.4]) and after 24 hours (61.1% [38.6, 83.6] versus mild/moderate (9.2% [4.2, 14.1], 10.6% [5.4,16.0]; P < 0.0001 for each). CONCLUSIONS: Preprocedure BUN level is associated with the development of PEP. The preprocedure BUN level and failure of the BUN level to decline during the first 24 hours are associated with prolonged hospitalization.