Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-03 @ 1:07 PM
Study NCT ID:
NCT05935969
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2023-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ETGBD in Surgically Unfit Patients With Both Choledocholithiasis and Cholecystolithiasis
Sponsor:
Seoul National University Hospital
Organization:
Study Overview
Official Title:
Endoscopic Transpapillary Gallbladder Drainage for Prevention of Biliary Complication in Surgically Unfit Patients With Both Choledocholithiasis and Cholecystolithiasis
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ETGBD
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.
Detailed Description:
Gallstones affect 10-15% of the adult population, and 10-25% of them may develop biliary pain or complications. Patients with symptomatic gallstones often have a concomitant CBD stone in 10-20% of them. Most gallstones do not require invasive treatment due to their benign natural history, but CBD stones should be removed due to the risk of developing gallstone-related complications such as obstructive cholangitis and acute gallstone pancreatitis. CBD stones result mainly from the migration of gallstones into the bile duct, so the gold standard treatment for gallstones with CBD stones is endoscopic removal of the CBD stone followed by cholecystectomy to prevent recurrent biliary complications, such as calculous cholangitis or acute cholecystitis.
However, patients who were ineligible for surgery due to high-risk conditions, including the elderly, critically ill status, and severe underlying morbidities, may not get the chance to undergo cholecystectomy. Initial nonoperative management with delayed cholecystectomy has been considered as an alternative treatment, but laparoscopic cholecystectomy reduces the rate of major complications compared with percutaneous gallbladder drainage, even in high-risk patients, and outcomes after early laparoscopic cholecystectomy in octogenarians are comparable to younger patients. Despite this evidence, there are still debates among experts for optimal treatment methods for high-risk patients for surgery with symptomatic CBD stone with gallstone, and gallbladder drainage therapy first to perform for stabilization with surgery rather than urgent cholecystectomy in real practice. Therefore, there is still an unmet need for how to prevent recurrence of CBD stones in patients with concomitant gallstones after endoscopic removal of CBD stones.
Nonsurgical cholecystic drainage methods, including percutaneous transhepatic gallbladder drainage (PTGBD), endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), and endoscopic transpapillary gallbladder drainage (ETGBD), have been introduced and actively used as a bridge or alternative therapy in patients at high risk for surgery. Several studies have reported the results of its feasibility and efficacy, mainly focusing on the management of patients with acute cholecystitis. However, the evidence for appropriate management considering non-surgical treatments for patients with both CBD stones and gallstones is still limited. This study evaluated the feasibility and efficacy of ETGBD for patients with both CBD stone and gallstones to prevent recurrent biliary complications in patients at high risk for surgery.
However, patients who were ineligible for surgery due to high-risk conditions, including the elderly, critically ill status, and severe underlying morbidities, may not get the chance to undergo cholecystectomy. Initial nonoperative management with delayed cholecystectomy has been considered as an alternative treatment, but laparoscopic cholecystectomy reduces the rate of major complications compared with percutaneous gallbladder drainage, even in high-risk patients, and outcomes after early laparoscopic cholecystectomy in octogenarians are comparable to younger patients. Despite this evidence, there are still debates among experts for optimal treatment methods for high-risk patients for surgery with symptomatic CBD stone with gallstone, and gallbladder drainage therapy first to perform for stabilization with surgery rather than urgent cholecystectomy in real practice. Therefore, there is still an unmet need for how to prevent recurrence of CBD stones in patients with concomitant gallstones after endoscopic removal of CBD stones.
Nonsurgical cholecystic drainage methods, including percutaneous transhepatic gallbladder drainage (PTGBD), endoscopic ultrasound-guided gallbladder drainage (EUS-GBD), and endoscopic transpapillary gallbladder drainage (ETGBD), have been introduced and actively used as a bridge or alternative therapy in patients at high risk for surgery. Several studies have reported the results of its feasibility and efficacy, mainly focusing on the management of patients with acute cholecystitis. However, the evidence for appropriate management considering non-surgical treatments for patients with both CBD stones and gallstones is still limited. This study evaluated the feasibility and efficacy of ETGBD for patients with both CBD stone and gallstones to prevent recurrent biliary complications in patients at high risk for surgery.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: