Common bile duct stenting after stone clearance in ERCP

Recruiting

Conditions: Disorders of gallbladder, biliarytract and pancreas in diseases classified elsewhere, (2) ICD-10 Condition: O||Medical and Surgical,

Registration Number: CTRI/2021/09/036538

Lead Sponsor: PGIMER

Brief Summary: Gall stone disease is a leading cause for hospitaladmissions related to gastrointestinal disorders. The incidence of common bileduct stones (CBDS) has been reported in 5-18% patients undergoingcholecystectomy for gallstones. The vast majority of CBDS arise fromgallbladder and migrate to common bile duct(CBD) following gallbladdercontraction. These stones may be asymptomatic or cause variety of problems likeobstruction and jaundice and other complication in the form of cholangitis,pancreatitis rarely mirrizi syndrome and bouveret syndrme. Endoscopicretrograde cholangiography(ERCP) with endoscopic sphincterotomy (EST) isaccepted as therapy of CBD stone. In acute situation, biliary stenting preventcomplication from cholangitis particularly after failed duct clearance. Howeverprophylactic CBD stent to eliminate complication can be done during ERCP. Oneprospective study that compared EST and CBD clearance without stenting vs CBDstenting did not show any benefit in CBD stenting. However there are not muchrandomized prospective studies and data to conclude CBD stenting is notbeneficial. So we planned this randomised controlled trial comparing CBDstent versus no stent for recurrence of CBD stone and biliary complications after ERCP and CBD clearance

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 70

Inclusion Criteria

Cases of choledocholithiasis with Gall Stone in whom CBD clearance achieved Definition of CBD clearance- after achieving clearance, on occlusion cholangiogram no filling defects seen on scout film.

Exclusion Criteria

Informed consent not available -Patients opting for single stage surgery -Previous hepatobiliary surgery -Failure to completely clear CBDS on ERCP -Previous cholecystectomy patients -Associated malignancy -Coagulopathy(INR>1.5, platlets<1lac).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To see the reduction on recurrence of CBD stone	At baseline, 1 week, 4 weeks, 8 weeks and 12 weeks

Secondary Outcome Measures

Name	Time	Method
(i)Difference in biliary and pancreatic complication rates	(ii)Need for repeat ERCP during the waiting period

Trial Locations

Locations (1): PGIMER
🇮🇳
Chandigarh, CHANDIGARH, India
PGIMER
🇮🇳Chandigarh, CHANDIGARH, India
HARSHAL MANDAVDHARE
Principal investigator
9592814877
hmandavdhare760@gmail.com