ETGBD in Surgically Unfit Patients With Both Choledocholithiasis and Cholecystolithiasis

NCT05935969 | Completed

• 1 other identifier: 2305-030-1429
• Study Type: observational
• Target: 302
• Locations: 1 country
• Sites: 1

Brief Summary

Cholecystectomy is recommended for patients with both gallbladder (GB) and common bile duct (CBD) stones to prevent recurrent biliary complications, unless there are specific reasons for surgery is considered inappropriate. The aim of this study was to evaluate the role of transpapillary gallbladder stent placement in surgically unfit patients with both CBD stone and gallstone.

Conditions

Efficacy

Keywords

Endoscopic transpapillary gallbladder drainage; High risk surgery; Gallstone; Common bile duct stone

Outcome Measures

Primary Outcomes (1)

• Recurrence of biliary complications

  The primary outcome measures were biliary complications, including acute cholecystitis, acute cholangitis, recurrence of choledocolithiasis, and biliary colic. The diagnosis of acute cholangitis, acute cholecystitis were based on Tokyo guideline 18.

  through study completion, an average of 2 year

Interventions

ERCP(Endoscopic retrograde choangiopancreatography), ETGBD(endoscopic transpapillary gallbladder drainage) PROCEDURE

For transpapillary gallbladder drainage, biliary cannulation was performed with a duodenoscope (JF-260V or TJF-260V; Olympus Optical). After successful deep cannulation of the CBD, we checked the cholangiogram, performed endoscopic sphincterotomy, and removed the CBD stone using a memory basket and/or retrieval balloon. Cholangiography was then performed again to locate the cystic duct orifice, and a guide wire (Jagwire; Boston Scientific, Marlborough, Massachusetts, USA or Visiglide; Olympus, Tokyo, Japan) was inserted into the gallbladder with different types of catheters (standard catheter, pull-sphincterotome, or rotating sphincterotome) under fluoroscopic guidance. After placement of the guide wire into the gallbladder, contrast dye was injected to confirm good entry into the gallbladder. Once the gallbladder was selected and the guidewire was coiled in the GB, a 7Fr 12-15cm double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Winston-Salem, NC) was inserted into the GB.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

From January 2010 to March 2022, 302 patients with both choledocholithiasis and cholecystolithiasis who were at high surgical risk, were reviewed retrospectively. All 302 patients were initially treated with endoscopic CBD stone removal.

You may qualify if:

• (i) age ≥20 years (ii) presence of choledocolithiasis and cholecystolithiasis on imaging studies (iii) surgically unfit for cholecystectomy.

You may not qualify if:

• (i) presence of malignant biliary obstruction (ii) follow-up of less than 1 month (iii) previous EST status (iv) pregnancy

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Links

• pubmed

MeSH Terms

Conditions

Gallstones

Condition Hierarchy (Ancestors)

Cholelithiasis; Biliary Tract Diseases; Digestive System Diseases; Cholecystolithiasis; Gallbladder Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Myeong Hwan Lee, M.D

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 27, 2023
• First Posted: July 7, 2023
• Study Start: August 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

KR (1)