Partially covered versus uncovered pyloro-duodenal stents for unresectable malignant gastric outlet obstruction: Randomized controlled study.

OBJECTIVES: The aim of the current study was to compare the efficacy of partially covered duodenal stent (PCDS) vs. uncovered duodenal stent (UCDS) in patients suffering from unresectable primary malignant gastric outlet obstruction (GOO). METHODS: This was a prospective international randomized controlled study conducted in 10 high-volume institutions. Consecutive patients suffering from malignant GOO were recruited. The primary outcome measurement was the reintervention rate. Secondary outcomes included technical and clinical success, 30-day adverse events, 30-day mortality, causes of stent dysfunction, and the duration of stent patency. RESULTS: Between March 2017 and October 2020, 115 patients (59 PCDS, 56 UCDS) were recruited. The 1-year reintervention was not significantly different (PCDS vs. UDCS = 12/59, 20.3% vs. 14/56, 25%, P = 0.84). There was a trend to fewer patients with tumor ingrowth in the PCDS group (6/59 [10.2%]) vs. 13/56 [23.2%], P = 0.07). There were no significant differences in the technical success (100% vs. 100%, P = 1), clinical success (91.5% vs. 98.2%, P = 0.21), procedural time (21.5 [interquartile range [IQR] 17-30] vs. 20.0 [IQR 15-34.75], P = 0.62), hospital stay (4 [IQR 3-12] vs. 5 [IQR 3-8] days, P = 0.81), 30-day adverse events (18.6% vs. 14.3%, P = 0.62), or 30-day mortality (6.8% vs. 5.2%, P = 1.00). CONCLUSION: The use of PCDS was associated with a lower risk of tumor ingrowth but did not improve on reintervention rates or stent patency. Both kinds of stents could be used in this group of patients.

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.

Impact of timing of ERCP on long term outcomes of ERCP for acute cholangitis - A single center retrospective study.

INTRODUCTION: Acute cholangitis is a critical medical emergency. The association between the timing of ERCP and clinical outcomes of acute cholangitis is still debated. The current study aims to evaluate whether ERCP within 48 h (urgent) is associated with improved long term clinical outcomes. METHODS: This study is a single-center retrospective analysis of a prospectively maintained database. All patients admitted with acute cholangitis as per Tokyo guidelines at AIG Hospitals, Hyderabad between January 2022 to December 2022 were included. We evaluated the association between urgent ERCP and length of hospital stay, need for reintervention and readmissions, and mortality. RESULTS: A total of consecutive 301 patients underwent ERCP for acute cholangitis; of which 217 patients (31.3 % females; mean age 54.02 ± 14.9 years) underwent urgent ERCP. The remaining 84 (32.1 % females; mean age 56.56 ± 13.9 years) underwent routine ERCP. Fifty-eight (26.7 %) and 22 (26.2 %) patients with Grade III underwent urgent and routine ERCP respectively. The median (IQR) hospital stay for urgent ERCP was 8.00 (6.00 - 11.00) days and for routine ERCP was 11.00(8.00 - 15.00; p value 0.0001), with similar hospital stay post ERCP (p 0.26). There was no significant difference in mortality upto one year between patients who underwent urgent (22.1 %;48/217) or routine ERCP (31.0 %;26/84, p 0.135). The cox proportional hazard model showed that mortality is independently associated with older age (HR 1.034;95 %CI: 1.013 - 1.054; p 0.001) and malignancy (HR 8.64;95 %CI:4.728 - 15.790; p 0.0001). There was no significant difference between two groups in terms of need for reinterventions and readmissions. CONCLUSIONS: Urgent ERCP for acute cholangitis is associated comparable overall mortality, need for reinterventions, and readmissions with decreased total length of hospital stay. There is an unmet need to confirm these findings by randomized controlled studies.

Adjuvant endobiliary radio-frequency ablation combined with self-expandable biliary metal stents for unresectable malignant hilar strictures: A pragmatic comparative study.

INTRODUCTION: The role of endo-biliary radio-frequency ablation (EB-RFA) in treating malignant biliary strictures remains a subject of controversy. This study aims to assess the efficacy and safety of EB-RFA in conjunction with self-expandable metal stents (SEMS) compared to SEMS alone. METHODS: This single-center prospective pragmatic comparative study, conducted between June 2021 and November 2022, involved 23 patients undergoing EB-RFA plus SEMS and 48 patients undergoing SEMS for unresectable malignant hilar obstruction. The study evaluated overall survival, stent patency and adverse events. RESULTS: Seventy-one patients (mean age [SD], 57.8 [11.2] years; 73.2% men) were enrolled. The clinical success rates did not significantly differ between the two groups (78.3% in EB-RFA and 66.6% in SEMS; p 0.316). The median (95% CI) overall survival was 155 (79.87-230.13) days in the EB-RFA group, contrasting with 86.0 (78.06-123.94) days in the SEMS group (p 0.020). The presence of carcinoma gallbladder (p 0.035; HR 0.55; 95% CI 0.32-0.96) and EB-RFA (p 0.047; HR 1.88; 95% CI 1.01-3.49) independently predicted overall survival. Median (95% CI) stent patency was 143.0 (95% CI, 61.61-224.39) days in the EB-RFA group compared to 78.0 (95% CI, 32.74-123.26) days in the SEMS group (p 0.019). The presence of carcinoma gallbladder (p 0.046, HR 0.60; 95% CI, 0.36-0.99), EB-RFA (p 0.023; HR 1.92; 95% CI, 1.10-3.36) and chemotherapy (p 0.017, HR 1.91; 95% CI, 1.12-3.26) independently predicted longer stent patency. There was no difference in procedure-related adverse events in both groups. CONCLUSION: EB-RFA with SEMS placement proves to be a safe and effective technique for palliative biliary decompression in patients with malignant biliary strictures, demonstrating superior overall survival and stent patency compared to SEMS alone. Further confirmation through multi-center trials is warranted. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (ID: NCT05320328).

Application of machine-learning model to optimize colonic adenoma detection in India.

AIMS: There is limited data on the prevalence and risk factors of colonic adenoma from the Indian sub-continent. We aimed at developing a machine-learning model to optimize colonic adenoma detection in a prospective cohort. METHODS: All consecutive adult patients undergoing diagnostic colonoscopy were enrolled between October 2020 and November 2022. Patients with a high risk of colonic adenoma were excluded. The predictive model was developed using the gradient-boosting machine (GBM)-learning method. The GBM model was optimized further by adjusting the learning rate and the number of trees and 10-fold cross-validation. RESULTS: Total 10,320 patients (mean age 45.18 ± 14.82 years; 69% men) were included in the study. In the overall population, 1152 (11.2%) patients had at least one adenoma. In patients with age > 50 years, hospital-based adenoma prevalence was 19.5% (808/4144). The area under the receiver operating curve (AUC) (SD) of the logistic regression model was 72.55% (4.91), while the AUCs for deep learning, decision tree, random forest and gradient-boosted tree model were 76.25% (4.22%), 65.95% (4.01%), 79.38% (4.91%) and 84.76% (2.86%), respectively. After model optimization and cross-validation, the AUC of the gradient-boosted tree model has increased to 92.2% (1.1%). CONCLUSIONS: Machine-learning models may predict colorectal adenoma more accurately than logistic regression. A machine-learning model may help optimize the use of colonoscopy to prevent colorectal cancers. TRIAL REGISTRATION: ClinicalTrials.gov (ID: NCT04512729).

Small Bowel Capsule Endoscopy: Experience from a single large tertiary care centre.

Background and study aims Capsule endoscopy (CE) has transformed examination of the small bowel (SB), once considered a dark continent. The present study aimed to describe the indications, diagnostic yield, practical issues and complications of CE in one of the largest tertiary center in India. Patients and methods This retrospective analysis from a prospectively maintained database, conducted from January 2013 to June 2021 included 1155 CEs performed during this period. Patient medical records were reviewed for indications, results, and complications of CE. Results A total of 1154 patients (809 males and 345 females), mean age 53 years (range 6-87 years), one capsule got stuck in the esophagus, were included in the study. Active SB bleeding had no effect on SB transit time (324.7±161 minutes, n = 137 patients with active bleed vs 310.6±166.9 minutes, n = 1017 patients without active bleed; P = 0.35). The indication and diagnostic yield (DY) of CE were potential overt SB bleed (68.6% & 43.9%), potential occult SB bleed (8.2% and 40%), chronic diarrhea (7.9% and 28.4%), abdominal pain (6.5% and 21.3%), anemia (5.9% and 57.9%), and suspected/known case of Crohn's disease (2.3% & 56.5%) respectively. The DY for patients with age ≥60 years was similar to those with age < 60 years (61.9% vs. 51.8% respectively; P = 0.4). 21 patients (1.8%) had capsule retention of which six (0.5%) had to be referred for surgery. Conclusions CE is a safe and effective investigation with ever increasing range of indications. Potential SB bleed remains the most common indication for CE with high detection rate.