臨床研究等提出・公開システム

Minimal endoscopic sphincterotomy with papillary balloon dilation versus endoscopic sphincterotomy for the treatment of common bile duct stones (MARBLE Trial)

MARBLE Trial

Inoue Tadahisa

Aichi Medical University

1-1 Yazakokarimata, Nagakute, Aichi

tinoue-tag@umin.ac.jp

Inoue Tadahisa

Aichi Medical University

1-1 Yazakokarimata, Nagakute, Aichi

+81-561623311

tinoue-tag@umin.ac.jp

Recruiting

April. 21, 2025

Interventional

randomized controlled trial

open(masking not used)

active control

parallel assignment

treatment purpose

1. Patients diagnosed with common bile duct stones via imaging modalities such as CT, MRCP, abdominal ultrasound, or endoscopic ultrasound.
2. Patients for whom endoscopic stone removal is deemed necessary.
3. Patients who are 18 years of age or older at the time of consent, regardless of gender.
4. Patietns who have received a thorough explanation of the study, fully understood it, and provided written informed consent voluntarily.

1. Patients with common bile duct stones measuring 12 mm or more in diameter.
2. Patients with surgically altered anatomy other than Billroth-I reconstruction.
3. Patients with biliary tract reconstruction.
4. Patients with concomitant biliary strictures.
5. Patients with biliary tumors, including duodenal papillary tumors.
6. Patients with intradiverticular papilla.
7. Patients taking antithrombotic agents where withdrawal or adjustment of medication is not feasible in accordance with the guidelines.
8. Patients with bleeding tendency (platelet count <50,000/mm3 or PT-INR >1.5).
9. Patients with concomitant severe cholangitis.
10. Patients with concomitant pancreatitis.
11. Patients with any prior intervention at the duodenal papilla.
12. Patients in which endoscopic treatment is deemed unsafe.
13. Patients who are pregnant or possibly pregnant.
14. Patients deemed unsuitable for this study by the principal investigator or sub-investigator.

Both

Common bile duct stone

Currently, endoscopic sphincterotomy (EST) is the first-line treatment for papillary intervention in the management of small common bile duct stones. This study aims to evaluate the efficacy of minimal endoscopic sphincterotomy with balloon dilation (ESBD) as a new therapeutic option for papillary intervention. To do this, we will conduct a randomized controlled trial, assigning patients in a 1:1 ratio to either the ESBD group or the conventional EST group, and compare outcomes between the two groups.

Common bile duct stone, Choledocholithiasis

minimal endoscopic sphincterotomy with balloon dilation, ESBD, endoscopic sphincterotomy, EST

D042883

D016717

The rate of procedure-related adverse event

1. Type and severity of procedure-related adverse events
2. Technical success rate (rate at which ESBD or EST was completed as per protocol)
3. Clinical success rate (rate of complete stone removal in a single session)
4. Total procedure time (from the start of biliary cannulation to completion of stone removal)
5. Procedure time required for stone removal (from completion of ESBD or EST to completion of stone removal)
6. Rate of mechanical lithotripsy performed
7. Stone recurrence rate during the follow-up period (up to 5 years after registration), following successful stone removal
8. Time to stone recurrence during the follow-up period (up to 5 years after registration), following successful stone removal
9. Incidence of biliary events during the follow-up period (up to 5 years after registration), following successful stone removal
10. Time to biliary event occurrence during the follow-up period (up to 5 years after registration), following successful stone removal

+81-561623311

Mar. 13, 2025

No

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