A multicenter randomized trial of endoscopic papillary large balloon dilation alone versus endoscopic sphincterotomy for removal of bile duct stones

A multicenter randomized trial of endoscopic papillary large balloon dilation alone versus endoscopic sphincterotomy for removal of bile duct stones - MARVELOUS Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010012

Enrollment

180

Registered

2013-02-12

Start date

2013-02-14

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bile duct stones

Interventions

EPLBD without EST EST

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Patients with large CBD stones(maximum stone size is greater than or equal to 10 mm), and the diameter of the distal common bile duct is greater than or equal to 12 mm 2) greater than or equal to 60 years old 3) Patients with written informed consent

Exclusion criteria

Exclusion criteria: 1) Patients with previous EST or EPBD 2) Patients after gastrectomy with Roux-en-Y reconstruction or Billroth II reconstruction 3) Patients with biliary strictures 4) Patients with acute pancreatitis 5) Patients with severe acute cholangitis 6) Patients with uncontrolled coagulopathy (e.g., LC, ESRD, etc.) 7) Patients considered ineligible for this study

Design outcomes

Primary

Measure	Time frame
Step 1 The rate of complete stone removal in the first session Step 2 Long-term outcomes after EPLBD alone versus EST	—

Secondary

Measure	Time frame
Step 1 1)Usage of mechanical lithotripsy 2)Stone removal time 3)Complete stone clearance rate 4)Early complication rates 5)Cost effectiveness Step 2 Late complication rates and stone recurrence rate	—

Countries

Japan

Contacts

Public ContactShuhei Kawahata, Hirofumi Kogure

Faculty of Medicine, The University of Tokyo Department of Gastroenterology

kawahata-hok@umin.ac.jp03-3815-5411

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026