NCT07455227

Brief Summary

to investigate the role and potential benefits or drawbacks of ERCP with sphincterotomy in patients declining subsequent cholecystectomy for gallstone-induced pancreatitis.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
23mo left

Started Apr 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026May 2028

First Submitted

Initial submission to the registry

March 3, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 6, 2026

Completed
26 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

March 6, 2026

Status Verified

May 1, 2025

Enrollment Period

1.1 years

First QC Date

March 3, 2026

Last Update Submit

March 3, 2026

Conditions

Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • recurrent pancreatitis

    1 year

Study Arms (2)

Placebo

NO INTERVENTION

ERCP

EXPERIMENTAL
Procedure: ERCP

Interventions

ERCPPROCEDURE

ERPC endoscopic sphictotomy

ERCP

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of gallstone-related pancreatitis (classified as mild pancreatitis according to the 2012 revised Atlanta classification and definitions).
  • Imaging studies reveal the presence of gallstones or sludge, along with at least one of the following conditions: i. Imaging evidence of common bile duct dilation (common bile duct diameter \> 8 mm for patients aged ≤ 75 years; \> 10 mm for patients aged \> 75 years).
  • ii. Biochemical evidence of cholestasis with total bilirubin levels between 1.8 - 4 mg/dL.
  • iii. Alanine aminotransferase (ALT) levels greater than twice the upper limit of normal.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pancreatitis

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

CholangiographyRadiography, AbdominalRadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, Digestive SystemEndoscopy, Digestive SystemEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2026

First Posted

March 6, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

March 6, 2026

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share