Endoscopic Sphincterotomy With Balloon Dilatation Versus Sphincterotomy Alone For Common Bile Duct Stones Removal

NCT05638789 | Completed

• 1 other identifier: HUSM
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Choledocholithiasis

Keywords

endoscopic sphincterotomy (EST); endoscopic papillary large balloon dilatation (EPLBD)

Outcome Measures

Primary Outcomes (2)

• Rate of complete common bile stone clearance of EST alone versus EST plus EPLBD

  to compare the rate of overall complete stone clearance in EST alone arm vs EST plus EPLBD arm

  12 months

• Complication rate of EST alone versus EST plus EPLBD in removing CBD stone

  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

Study Arms (2)

EST alone

ACTIVE COMPARATOR

Procedure: endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD)

EST + EPLBD

ACTIVE COMPARATOR

Procedure: endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD)

Interventions

endoscopic sphincterotomy (EST) versus EST plus endoscopic papillary large balloon dilatation (EPLBD) PROCEDURE

EST alone vs EST plus EPLBD in removing common bile duct stone

EST + EPLBD; EST alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient's age 18 and above
• Patient with CBD stone documented on imaging studies

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia: lead

Study Sites (1)

Department of Surgery School of Medical Sciences, Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (7)

• 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.

  PMID: 2070995 RESULT

• 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.

  PMID: 15816433 RESULT

• 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.

  PMID: 6516498 RESULT

• 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.

  PMID: 17509029 RESULT

• 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.

  PMID: 23613639 RESULT

• 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.

  PMID: 27488319 RESULT

• 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.

  PMID: 19551331 RESULT

MeSH Terms

Conditions

Choledocholithiasis

Interventions

Sphincterotomy, Endoscopic

Condition Hierarchy (Ancestors)

Common Bile Duct Diseases; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Cholelithiasis

Intervention Hierarchy (Ancestors)

Biliary Tract Surgical Procedures; Digestive System Surgical Procedures; Surgical Procedures, Operative; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Endoscopy; Minimally Invasive Surgical Procedures; Sphincterotomy; Myotomy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 66 patients with CBD stone will be divided into two groups which is Group A(EST+EPLBD) (33 cases) and Group B (EST alone) (33 cases). Randomization will be done using computer software for sequence generation and was stratified with 1:1 allocation using random block sizes of 6 and 8 to Group A or Group B. The allocation concealment mechanism was developed by preparing 88 sealed and opaque envelopes. Each envelop contain one allocation sequence which is generated by computer software. Data collection officer will randomly open one of the envelop each time one patient recruited and will need to follow the allocation sequences inside the envelop in order to determine whether the patient to be Group A or Group B patient. This is single blinded study whereby the participant is blinded but the endoscopist is not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PRINCIPAL INVESTIGATOR

Model Details: EST alone versus EST + EPLBD group

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: December 6, 2022
• Study Start: June 28, 2021
• Primary Completion: June 27, 2022
• Study Completion: June 27, 2022
• Last Updated: December 6, 2022

Record last verified: 2022-11

Locations

MY (1)