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.

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.

Endoscopic "step-up approach" using a dedicated biflanged metal stent reduces the need for direct necrosectomy in walled-off necrosis (with videos).

BACKGROUND AND AIMS: EUS-guided drainage using plastic stents may be inadequate for treatment of walled-off necrosis (WON). Recent studies report variable outcomes even when using covered metal stents. The aim of this study was to evaluate the efficacy of a dedicated covered biflanged metal stent (BFMS) when adopting an endoscopic "step-up approach" for drainage of symptomatic WON. METHODS: We retrospectively evaluated consecutive patients with symptomatic WON who underwent EUS-guided drainage using BFMSs over a 3-year period. Reassessment was done between 48 and 72 hours for resolution. Endoscopic reinterventions were tailored in nonresponders in a stepwise manner. Step 1 encompassed declogging the blocked lumen of the BFMS. In step 2, a nasocystic tube was placed via BFMSs with intermittent irrigation. Step 3 involved direct endoscopic necrosectomy (DEN). BFMSs were removed between 4 and 8 weeks of follow-up. The main outcome measures were technical success, clinical success, adverse events, and need for DEN. RESULTS: Two hundred five WON patients underwent EUS-guided drainage using BFMSs. Technical success was achieved in 203 patients (99%). Periprocedure adverse events occurred in 8 patients (bleeding in 6, perforation in 2). Clinical success with BFMSs alone was seen in 153 patients (74.6%). Reintervention adopting the step-up approach was required in 49 patients (23.9%). Incremental success was achieved in 10 patients with step 1, 16 patients with step 2, and 19 patients with step 3. Overall clinical success was achieved in 198 patients (96.5%), with DEN required in 9.2%. Four patients failed treatment and required surgery (2) or percutaneous drainage (2). CONCLUSIONS: The endoscopic step-up approach using BFMSs was safe, effective, and yielded successful outcomes in most patients, reducing the need for DEN.