Endoscopic Sphincterotomy With Balloon Dilatation Versus Sphincterotomy Alone For Common Bile Duct Stones Removal
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kelantan
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Kubang Kerian, Kelantan, Malaysia, 16150
- Department of Surgery School of Medical Sciences, Universiti Sains Malaysia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patient's age 18 and above
- Patient with CBD stone documented on imaging studies
Exclusion Criteria:
- CBD stone size more than 15mm
- CBD stone number more than 3
- Concurrent hepatobiliary tumour
- Intrahepatic stone
- Bleeding tendencies: coagulopathy, thrombocytopenia, patient on anticoagulant medication
- Patient in sepsis/ Cholangitis patient
- Patient with acute pancreatitis
- Prior history of Bilroth II or Roux-en-y surgery
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: EST alone
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EST alone vs EST plus EPLBD in removing common bile duct stone
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Active Comparator: EST + EPLBD
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EST alone vs EST plus EPLBD in removing common bile duct stone
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of complete common bile stone clearance of EST alone versus EST plus EPLBD
Time Frame: 12 months
|
to compare the rate of overall complete stone clearance in EST alone arm vs EST plus EPLBD arm
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12 months
|
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Complication rate of EST alone versus EST plus EPLBD in removing CBD stone
Time Frame: 12 months
|
to compare complication rate which are post ERCP bleeding, post-ERCP pancreatitis, perforation and cholangitis rate of EST alone arm versus EST plus EPLBD arm in removing CBD stone
|
12 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Cotton PB, Lehman G, Vennes J, Geenen JE, Russell RC, Meyers WC, Liguory C, Nickl N. Endoscopic sphincterotomy complications and their management: an attempt at consensus. Gastrointest Endosc. 1991 May-Jun;37(3):383-93. doi: 10.1016/s0016-5107(91)70740-2.
- Suissa A, Yassin K, Lavy A, Lachter J, Chermech I, Karban A, Tamir A, Eliakim R. Outcome and early complications of ERCP: a prospective single center study. Hepatogastroenterology. 2005 Mar-Apr;52(62):352-5.
- 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.
- Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
- Fu BQ, Xu YP, Tao LS, Yao J, Zhou CS. Endoscopic papillary balloon intermittent dilatation and endoscopic sphincterotomy for bile duct stones. World J Gastroenterol. 2013 Apr 21;19(15):2425-32. doi: 10.3748/wjg.v19.i15.2425.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUSM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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