Clinical trial NCT05638789: Endoscopic Sphincterotomy With Balloon Dilatation Versus Sphincterotomy Alone For Common Bile Duct Stones Removal
Official title: Endoscopic Sphincterotomy With Balloon Dilatation Versus Sphincterotomy Alone For Common Bile Duct Stones Removal
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Choledocholithiasis
Keywords: endoscopic sphincterotomy (EST)
endoscopic papillary large balloon dilatation (EPLBD)
Lead sponsor: Hospital Universiti Sains Malaysia
Sponsor class: OTHER
First posted: 2022-12-06
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: EST alone versus EST + EPLBD group
Primary purpose: TREATMENT

Brief summary: Gallstone is a worldwide clinical problem which affecting most of the populations with incidence of 15 to 20% in west and 10% in Asians. About 5 to 15% of patient with gallstone will go on to develop bile duct calculi. There are several endoscopic strategies developed for treatment of common bile duct stone such as endoscopic sphincterotomy (EST), endoscopic papillary large balloon dilatation (EPLBD) and combination of EST plus EPLBD. Our aim of this study is to compare efficacy, and safety of EST alone group versus EST plus EPLBD group in removing CBD stone.

Detailed description: Endoscopic sphincterotomy (EST) is most widely used during endoscopic retrograde cholangiopancreatography (ERCP) to remove common bile duct (CBD) stone and considered as standard therapy for treatment of choledocholithiasis. However, in view of EST requires an adequate incision on major duodenal papilla to achieve biliary cannulation, it can potentially cause damage to biliary sphincter during the procedure and potentially increased risk of some complications such as bleeding and biliary reflux. This procedure carries risk of complications such as haemorrhage, perforation, and long-term effect like sphincter dysfunction.

Staritz introduced a method called endoscopic papillary large balloon dilatation (EPLBD) in 1983 as an alternative to EST in clearing CBD stone. EPLBD can reduced the risk of bleeding and perforation post procedure, but it carries higher risk of post-ERCP pancreatitis.

About 10 to 15% of CBD stone are unable to be extracted by both EST or EPLBD alone, especially in those patients with big and difficult stone (size bigger than 10 to 15mm, numerous, barrel-shaped, and impacted stones). Besides that, other factors that can contribute to failure of stone extraction are periampullary diverticulum or post operative variation, tortuosity and tightening of distal common bile duct.

In 2003, Ersoz introduced combination of EST plus EPLBD as an alternative method. It can reduce the risk of complications through avoiding a complete sphincterotomy, shortening procedural time, and reducing the need of usage of mechanical lithotripsy.

In a study on 2007, it showed that EST plus EPLBD had comparable efficacy and safety when compared to conventional EST alone and both groups have similar complication rate. Besides that, in a recent study in 2020, it also showed that EST plus EPLBD had a comparable efficacy when compared with EST alone in clearing CBD stone and EST plus EPLBD required shorter procedural time when compared with EST alone. There is no significant increased risk in pancreatitis for EST plus EPLBD. While, in a randomized controlled study in 2017, it showed that EST plus EPLBD is more effective than EST alone in clearing large CBD stone and is equally safe compared to EST alone. In another randomized controlled trial in 2013, the study showed that the success rate for complete CBD stone removal in first session is higher in EST plus EPLBD group when compared to EST alone and it is statistically significant. But the overall stone clearance rate and complication rate was similar in both groups. Apart from that, there are many other studies have suggested EST plus EPBD as a safe and promising alternative to conventional EST or EPLBD. In a published meta-analysis, accumulated data showed that EST plus EPLBD is a safe and effective procedure in removing large or difficult CBD stone without any additional risk of complications.

There is still no definite conclusion in evaluating superiority of EST plus EPLBD vs EST alone in term of efficacy in removing CBD stone.

Eligibility criteria: Inclusion Criteria:

1. Patient's age 18 and above
2. Patient with CBD stone documented on imaging studies

Exclusion Criteria:

1. CBD stone size more than 15mm
2. CBD stone number more than 3
3. Concurrent hepatobiliary tumour
4. Intrahepatic stone
5. Bleeding tendencies: coagulopathy, thrombocytopenia, patient on anticoagulant medication
6. Patient in sepsis/ Cholangitis patient
7. Patient with acute pancreatitis
8. Prior history of Bilroth II or Roux-en-y surgery

Primary outcomes:
measure: Rate of complete common bile stone clearance of EST alone versus EST plus EPLBD
timeFrame: 12 months
measure: Complication rate of EST alone versus EST plus EPLBD in removing CBD stone
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Kubang Kerian
country: Malaysia
facility: Department of Surgery School of Medical Sciences, Universiti Sains Malaysia
state: Kelantan
Study officials:
References:
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citation: Staritz M, Ewe K, Goerg K, Meyer zum Buschenfelde KH. Endoscopic balloon tamponade for conservative management of severe hemorrhage following endoscopic sphincterotomy. Z Gastroenterol. 1984 Nov;22(11):644-6.
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citation: Shim CS, Kim JW, Lee TY, Cheon YK. Is endoscopic papillary large balloon dilation safe for treating large CBD stones? Saudi J Gastroenterol. 2016 Jul-Aug;22(4):251-9. doi: 10.4103/1319-3767.187599.
citation: Attam R, Freeman ML. Endoscopic papillary large balloon dilation for large common bile duct stones. J Hepatobiliary Pancreat Surg. 2009;16(5):618-23. doi: 10.1007/s00534-009-0134-2. Epub 2009 Jun 24.