Outcome of endosopic ultrasound guided biliary stenting to relieve jaundice due to cancer.

Phase 2

Not yet recruiting

• Conditions: Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere,

• Registration Number: CTRI/2025/04/083940
• Lead Sponsor: EUS Educational foundation

Brief Summary

EUS-guided biliary drainage is an effective modality for management of malignant obstructive jaundice. Randomized studies and meta-analyses have shown EUS-BD to be equivalent to ERCP in patients with distal malignant obstructive jaundice. The main advantage of EUS-BD is its ability to access the biliary tree from the stomach, duodenum, and also the papilla. The two main routes of drainage are trans-luminal and Tans-papillary. The trans-luminal route creates an anastomosis between the bile duct and duodenum (choledocho-duodenostomy, CDS) or between stomach and left intrahepatic biliary radical( Hepatico-gastrostomy, HGS). The trans-papillary route accesses the biliary system from the left intra-hepatic biliary radical, and places a stent across the papilla (antegrade, AG). A randomized study and a meta analysis has shown CDS and HGS to be equally effective. In a recent randomized study, we have shown that trans-papillary route results in longer stent patency. We have postulated that areas of bile stasis in the distal bile duct may promote early stent block in CDS and HGS. Recent studies have shown that a combination of HGS and AG produce longer stent patency compared to HGS alone. This may be due to better drainage from the distal bile duct by the trans-papillary stent, thus avoiding stasis. A combination of HGS and AG requires two stents, and takes longer procedure time. It is possible that a single long stent combining properties of both HGS and AG will provide longer stent patency and will be easier to place.

Hypothesis

We hypothesized that a long stent extending from proximal stomach across the left intrahepatic biliary radical, liver hilum, common bile duct and papilla into the duodenum should provide long term relief of malignant obstructive jaundice. We also hypothesized that since this stent has dual bile drainage in the stomach as well as duodenum, a smaller diameter than the existing stent may be sufficient.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-03-28
• Study Start: 2025-04-21

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

Unresectable malignant biliary obstruction (malignant distal biliary obstruction and Type I hilar block) with failed ERCP.

Exclusion Criteria

Previous history of ERCP with plastic or metal stent in-situ or PTBD, hilar block II-IV, patients on neo-adjuvant chemotherapy, pregnancy, participation in another investigational trial within 180 days, bleeding tendencies, ascites and benign biliary strictures.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical and clinical success	2 weeks

Secondary Outcome Measures

Name	Time	Method
Adverse events in the from of stent migration, stent block, cholangitis	4 weeks

Trial Locations

Locations (1)

Department of gastroenterology, Institute of Digestive and Liver Care; 🇮🇳 Mumbai, MAHARASHTRA, India

Department of gastroenterology, Institute of Digestive and Liver Care

🇮🇳Mumbai, MAHARASHTRA, India

Vinay Dhir

Principal investigator

9819920266

vinaydhir@gamil.com