A Randomized, Controlled Trial Comparing the Total Enteroscopy Rate and Diagnostic Efficacy of Novel Motorized Spiral Enteroscopy and Single-Balloon Enteroscopy in Patients With Small-Bowel Disorders: The Motor Trial (NCT 05548140).

INTRODUCTION: Device-assisted enteroscopy has revolutionized the management of small-bowel disorders (SBD). No study to date has compared both novel motorized spiral enteroscopy (NMSE) and single-balloon enteroscopy (SBE) as a randomized controlled trial. Hence, this study was planned to include patients having SBD with the primary aim to compare the total enteroscopy rate (TER). METHODS: This study was conducted at the Asian Institute of Gastroenterology (AIG Hospitals), Hyderabad, India, from September 20, 2022, to December 15, 2022. All consecutive patients, older than 18 years with suspected SBD, and planned for total enteroscopy were screened for inclusion. The primary outcome was to compare the TER, and secondary outcomes were to compare the technical success, time taken to reach the depth of maximal insertion, withdrawal time, total procedure time, diagnostic yield, therapeutic success, and adverse events (AE). RESULTS: Seventy-two patients of the 110 patients screened were randomized in either NMSE (n = 35) or SBE (n = 37) group. The most common indication for the procedures was obscure gastrointestinal bleed (48%), others being unexplained abdominal pain with indeterminate radiologic findings (32%) and chronic diarrhea (20%). In NMSE group, the TER was 71.4%, whereas in the SBE group, it was 10.8% ( P < 0.0001). The total procedure time (minutes) was much lesser with NMSE (58.17 ± 21.5 minutes) vs SBE (114.2 ± 33.5 minutes) ( P < 0.0001). The diagnostic yield of NMSE (80%) was comparatively higher than SBE (62.1%) ( P = 0.096). Minor AE (grade I) were observed in both the groups: NMSE 8.5% (3/35) and SBE 5.4% (2/37). DISCUSSION: This randomized controlled trial shows that with NMSE higher TER can be achieved in shorter duration with minimal AE, compared with SBE.

Diagnostic yield and technical performance of the novel motorized spiral enteroscopy compared with single-balloon enteroscopy in suspected Crohn's disease: a prospective study (with video).

BACKGROUND AND AIMS: Both single-balloon enteroscopy (SBE) and the novel motorized spiral enteroscopy (NMSE) are effective techniques for device-assisted enteroscopy (DAE). To date, no study has prospectively compared both modalities in suspected Crohn's disease (CD). METHODS: Patients with suspected CD undergoing either SBE or NMSE between March 2021 and December 2021 in a high-volume tertiary center were prospectively compared for technical success (ability to reach the lesion), diagnostic yield, depth of maximal insertion (DMI), procedure time, and total enteroscopy rates. RESULTS: One hundred seventy-seven patients (37.2% female; aged 7-75 years) with suspected CD underwent 201 DAEs. Technical success was 83% (SBE 81.5% vs NMSE 87.3%, P = .61) and impacted subsequent management in 92% (SBE 88.5% vs NMSE 97.8%, P = .2). Technical success with antegrade NMSE was significantly higher (81.4%) than antegrade SBE (33.3%, P = .007) for lesions in the proximal ileum and beyond. There was no significant difference in the diagnostic yield (SBE 80.8% vs NMSE 83.6%, P = .65). Median procedure time was significantly lower in both antegrade (NMSE, 40 minutes [range, 10-75]; SBE, 60 minutes [range, 20-180]; P < .0001) and retrograde (NMSE, 25 minutes [range, 20-60]; SBE, 60 minutes [range, 20-180]; P < .0001) NMSE. Median DMI was higher with antegrade NMSE (NMSE, 400 cm [range, 70-600]; SBE, 180 cm [range, 60-430]; P < .0001). The total enteroscopy rate was higher with NMSE (37% vs .7% with SBE, P < .0001). All adverse events were mild. CONCLUSIONS: Both NMSE and SBE are safe and effective for small-bowel evaluation in suspected CD. NMSE is superior to SBE with regard to deeper small-bowel evaluation with complete small-bowel coverage and shorter procedure time.

Endoscopic sleeve gastroplasty - minimally invasive treatment for non-alcoholic fatty liver disease and obesity.

INTRODUCTION: Adequate weight loss can lead to reduction in steatosis, inflammation, and fibrosis in patients with obesity and non-alcoholic fatty liver disease (NAFLD). We evaluated the role of endoscopic sleeve gastroplasty (ESG) in patients with obesity and NAFLD. METHODS: In this single-center prospective study, consecutive adult patients with NAFLD who underwent ESG between November 2018 and May 2019 were included. The primary outcome was the impact of ESG on hepatic parameters: change in alanine aminotransferase (ALT), hepatic steatosis index (HSI), NAFLD fibrosis score (NFS), fibrosis-4 index (FIB-4), and aspartate aminotransferase (AST)-to-platelet ratio index (APRI) from baseline to 6 and 12 months. Secondary outcomes included change in glycated hemoglobin (HbA1c), percentage weight loss, and safety. Analysis of variance with repeated measures was used for statistical analysis. RESULTS: A total of 26 patients (mean age [SD] 41.5 [9.58] years; 16 females) with mean (SD) weight of 99.43 (21.89) kg at baseline were included. There was significant improvement in ALT (mean ± SD) from baseline of 59.54 ± 17.02 IU/L to 49.50 ± 11.72 IU/L and 48.42 ± 13.22 IU/L at 6 and 12 months (p = 0.001). Mean (SD) NFS was significantly improved from 0.228 (1.00) at baseline to -0.202 (1.16) and -0.552 (1.08) at 6 and 12 months (p 0.001). Mean (SD) HSI, FIB-4, and APRI scores significantly reduced from baseline to 6 and 12 months (p = 0.001). There was 18.07% total body weight loss at 12 months, with significant improvement in HbA1c. There were no major adverse events. CONCLUSION: ESG is a safe and effective treatment option for patients with NAFLD and obesity causing significant weight loss. Rigorous randomized trials are required to incorporate ESG in NAFLD treatment algorithm.

To assess the efficacy of safety measures adopted during endoscopy in the Corona Virus Disease-19 era for health care professionals-A single-centre tertiary care hospital experience.

BACKGROUND AND OBJECTIVES: During Corona Virus Disease-19 (COVID-19) pandemic, it has been estimated that approximately 10% of health care professionals (HCPs) have been diagnosed contacting  COVID-19. Aerosol-generating procedures have led to change in safety practices among HCPs. We thus evaluated the efficacy of the endoscopic safety measures among HCPs posted in the endoscopy unit. METHODS: In this retrospective analysis, all endoscopic procedures performed over a period of 4 months, from 1 April to 31 July 2020 were included. We noted indications and number of COVID-positive procedures as well as comprehensive screening of HCPs posted in our endoscopy unit. The aim of the study was to evaluate the incidence and outcome of COVID-19 among HCPs. RESULTS: Three thousand four hundred and sixty procedures were included in the analysis. Indications were divided as urgent (n = 190, 5.49%), semi-urgent (n = 553, 16%) and non-urgent group (n = 2717, 78.52%). Thirty-four procedures (0.98%) were done on diagnosed COVID-19 patients. The most common indications were gastrointestinal bleed (n = 12/34, 35.30%) followed by biliary sepsis (n = 9/34, 26.5%). Among the HCPs, the incidence of symptomatic COVID-19 was 6.58% (n = 5/76). All HCPs recovered with excellent outcomes. A comprehensive screening showed 7.90% (n = 6/76) HCPs having Immunoglobulin G (IgG) antibody in their sera. CONCLUSION: Addition of safety measures in endoscopy leads to low risk of transmission among HCPs.

Diagnostic yield and therapeutic impact of novel motorized spiral enteroscopy in small-bowel disorders: a single-center, real-world experience from a tertiary care hospital (with video).

BACKGROUND AND AIMS: Novel motorized spiral enteroscopy (NMSE) is a recent advancement in the field of enteroscopy and offers multiple features, including self-propulsion, better irrigation, and shorter enteroscope length with a larger channel. The aim of this study was to evaluate the efficacy in terms of diagnostic yield and therapeutic success of NMSE in patients undergoing enteroscopy by antegrade and/or retrograde approaches for suspected small-bowel disease. METHODS: We retrospectively evaluated consecutive patients with symptomatic small-bowel disease who underwent enteroscopy over a 6-month period. Diagnostic yield, therapeutic success, total enteroscopy rate (TER), technical success, total procedural time, depth of maximal insertion, and adverse events related to the NMSE procedure were noted. RESULTS: Of 61 patients (mean age, 45.67 ± 15.37 years; 43 men) included for NMSE, 57 patients underwent successful enteroscopy with a technical success of 93.4%. The overall diagnostic yield was 65.5% (95% confidence interval, 52.31-77.27) and 70.1% (95% confidence interval, 56.60-81.57) in patients who underwent successful NMSE; TER was 60.6%: 31.1% by the antegrade approach and 29.5% by a combined antegrade and retrograde approach. Depth of maximal insertion and procedural time was of 465 cm (range, 100-650) and 40 minutes (range, 25-60), respectively, by the antegrade approach and 140 cm (range, 50-200) and 35 minutes (range, 30-60) by the retrograde route. Lesions were classified as inflammatory (n = 25), vascular (n = 10), and mass (n = 4). Biopsy specimens were obtained in 50.8% subjects, and 23% patients underwent therapeutic procedures. No major adverse events were seen. CONCLUSIONS: NMSE is a promising technology, showing high efficacy as a diagnostic and therapeutic tool in the management of otherwise difficult-to-treat small-bowel disease.

Impact of ductal interventions on diabetes in patients with chronic pancreatitis.

BACKGROUND AND AIM: Even though ductal interventions in chronic pancreatitis (CP) are known to improve pain, its impact on diabetes is unclear. In this cohort study, we evaluated the impact of ductal interventions on diabetes in these patients. METHODS: Consecutive patients with CP visiting the pancreas clinic between August 1, 2011, and July 21, 2012, were enrolled and followed until December 2018. Detailed clinical, laboratory, imaging, and treatment data were recorded at enrolment and follow-up. Patients were followed up every 6 months through hospital visit and/or telephonic interview. Risk factors for diabetes were evaluated using logistic regression. The impact of ductal interventions on diabetes was evaluated using Kaplan-Meier survival analyses and Cox proportional hazards. RESULTS: A total of 644 patients were enrolled of which 137 were excluded. Of these, 326 (64.3%) patients had idiopathic CP, and 283 (55.8%) patients underwent ductal intervention. The cumulative incidence of diabetes was 57.9%. Median duration between symptom onset and ductal intervention was similar irrespective of diabetes (2.6 [0.6-6.0] vs 3.0 [1.0-5.5] years; P = 0.69). Alcohol intake and pancreatic ductal calculi were independent risk factors for diabetes (odds ratio [95% confidence interval] of 2.05 (1.18-3.55), P = 0.01, and 2.05 (1.28-3.28), P = 0.003, respectively). Kaplan-Meier analyses revealed that diabetes free interval was significantly longer in patients undergoing ductal interventions, predominantly in those with idiopathic CP with obstructive ductal calculi (hazard ratio [95% confidence interval] 0.39 [0.28-0.55]; P < 0.0001). There were no differences in glycemic status in patients with non-idiopathic CP and those with pre-existing diabetes. CONCLUSION: Early ductal intervention could delay development of diabetes in patients with idiopathic CP with obstructive ductal calculi.

Clinical utility of ESGE and ASGE guidelines for prediction of suspected choledocholithiasis in patients undergoing cholecystectomy.

BACKGROUND: Recent guidelines from the European Society of Gastrointestinal Endoscopy (ESGE) and American Society for Gastrointestinal Endoscopy (ASGE) recommend risk stratification according to liver function test (LFT) and abdominal ultrasound in patients with suspected choledocholithiasis. We evaluated and validated the clinical utility of these new risk stratification criteria for choledocholithiasis. METHODS: We retrospectively analyzed prospectively maintained data of patients with suspected choledocholithiasis between January 2016 and December 2018 in patients undergoing cholecystectomy. Patients with common bile duct stricture, cirrhosis, and portal biliopathy were excluded. After LFT and ultrasound, all patients were stratified according to ESGE and ASGE criteria into high, intermediate, and low likelihood of choledocholithiasis. RESULTS: 1042 patients were analyzed. Using ESGE guidelines, 213 patients (20.4 %) met high likelihood criteria, 637 (61.1 %) met intermediate, and 192 (18.4 %) met low likelihood criteria. Using ASGE guidelines, 230 (22.1 %), 678 (65.1 %), and 134 (12.9 %) met high, intermediate, and low likelihood criteria, respectively. Specificity and positive predictive value (PPV) of ASGE high likelihood criteria were 96.87 % (95 % confidence interval [CI] 95.37 - 97.98) and 89.57 % (95 %CI 85.20 - 92.75) for choledocholithiasis compared with 98.96 % (95 %CI 97.95 - 99.55) and 96.24 % (95 %CI 92.76 - 98.09), respectively, for ESGE criteria. ASGE classified 17 (7.4 %) additional patients as high likelihood compared with ESGE, only one of whom had choledocholithiasis. ASGE classified 58 (8.6 %) additional patients as intermediate, none of whom had choledocholithiasis. CONCLUSION: This study validates the clinical utility of new ESGE and ASGE criteria for predicting choledocholithiasis. ESGE risk stratification appears more specific than ASGE.

Is It Safe to Perform Endoscopic Retrograde Cholangiopancreatography in Decompensated Cirrhosis?

BACKGROUND AND AIM: Endoscopic retrograde cholangiopancreatography (ERCP) is treatment modality of choice for management of pancreatobiliary disorders. However, safety of ERCP in the patients with cirrhosis is not adequately studied. This study was aimed to evaluate adverse events in the patients with cirrhosis undergoing ERCP and the predictors of adverse events and mortality. METHODS: The present study was a retrospective analysis of patients with cirrhosis who underwent ERCP from January 2012 to December 2016. Binary logistic regression analysis was performed to ascertain the risk factors for adverse events and mortality at 1 month. RESULTS: A total of 261 patients underwent ERCP (80.8% men, mean age 53.49 ± 12.6years). There were 36 (16.1%) overall adverse events in patients undergoing ERCP for biliary indication, whereas no adverse event in pancreatic indication. On univariate analysis, ascites, encephalopathy, high Child-Pugh-Turcotte (CTP) and model for end-stage liver disease (MELD) score, and creatinine levels were significantly associated; however, on multivariable analysis, CTP class C (p value 0.033; odds ratio [OR] 3.5, 95% confidence interval [CI] 1.1-11.5) and MELD > 18 (p value 0.004; OR 5.6, 95% CI 1.7-17.9) were independent risk factors for adverse events. There were 19 (8.5%) mortalities. On univariate analysis, presence of ascites, encephalopathy, cholangitis, biliary sphincterotomy, high CTP, low albumin, and high creatinine were significantly associated, whereas, on multivariable analysis, presence of cholangitis (p 0.017; OR 3.8, 95% CI 1.3-11.4) was associated increased mortality. CONCLUSION: Although endoscopic sphincterotomy might be safe for the patients with cirrhosis undergoing ERCP; advanced liver cirrhosis may be independent risk factor for post-ERCP adverse events. Cholangitis at admission is an independent risk factor for mortality.

Budd-Chiari syndrome: outcomes of endovascular intervention-A single-center experience.

AIM: Outcomes of endovascular intervention in Budd-Chiari syndrome (BCS) have been reported with varied results. Clinical outcomes of endovascular interventions in BCS and role of various prognostic scores were critically evaluated in this study. METHODS: This study retrospectively analyzed consecutive patients of BCS who underwent endovascular intervention between January 2007 and May 2016 at our center. Technical, clinical successes and complications were documented. The role of the prognostic scores such as Child-Turcotte-Pugh (CTP), model for end-stage liver disease (MELD), Rotterdam index, and original Clichy score in predicting mortality, clinical success, and need for re-interventions were also assessed. RESULTS: A total of 88 patients were analyzed. The median follow up was 12 months (range 1-96 months). Thirteen (14.8%) patients had combined inferior vena cava (IVC) and hepatic vein (HV) obstruction; HV obstruction in 33 (37.5%) and inferior vena cava IVC obstruction in 42 (47.7%) patients. The following interventions were done: IVC angioplasty alone (n = 11), IVC angioplasty with stenting (n = 36), HV angioplasty with stenting (n = 26), combined HV and IVC stent (n = 2), and direct intrahepatic porto-systemic shunt (DIPS) (n = 13). Overall technical success was 87/88 (98.86%), and clinical success was 76/88 (86.36%). Immediate complications were noted in 8 patients (10%). The 1-, 2-, 3-, and 4-year stent patency rates were 90.91%, 81.08%, 74.59%, and 70.45%, respectively. Re-interventions were required in 15 (17%). Overall mortality was 6 (6.8%). Apart from MELD >14, none of the other prognostic score could predict mortality, clinical success, and need for re-interventions. CONCLUSION: Endovascular interventions play an important role in the management of BCS, in properly selected patients, even if prognostic score is unfavorable.