NCT06391359

Brief Summary

Rationale: Annually, acute pancreatitis is diagnosed in 6,500 patients in the Netherlands. In up to 25% of patients no definitive cause can be determined after routine work-up including endoscopic ultrasound and this is deemed to be idiopathic acute pancreatitis (IAP). IAP is known for its high recurrence rate. It is hypothesized that microlithiasis, a type of biliary pancreatitis, is the most common cause of IAP. Laparoscopic cholecystectomy (LC) is highly effective in preventing recurrence of biliary pancreatitis. Currently no randomized trial has compared LC with conservative treatment in patients with IAP after adequate work-up including endoscopic ultrasound. Objective: To assess the effectiveness of LC as compared to conservative treatment in patients after a first, second or third episode of an 'EUS-negative' IAP. Study design: Multicenter randomized controlled trial. Patients will be followed for one year after randomization. Study population: Adults with a first, second or third episode of IAP, of which at least one episode is characterized by a 'negative EUS'. Intervention (if applicable): Laparoscopic cholecystectomy versus conservative treatment. Main study parameters/endpoints: The primary endpoint is pancreatitis recurrence. Secondary endpoints include occurrence of biliary events, complications of LC, number and severity of recurrent episodes of pancreatitis, quality of life (QALY), costs (hospital and societal) and cost-effectiveness.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
262

participants targeted

Target at P75+ for not_applicable

Timeline
24mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
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 Progress60%
Jul 2023Jul 2028

Study Start

First participant enrolled

July 30, 2023

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2024

Completed
3 months until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2028

Last Updated

August 3, 2026

Status Verified

July 1, 2026

Enrollment Period

4 years

First QC Date

January 30, 2024

Last Update Submit

July 31, 2026

Conditions

Idiopathic Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Acute pancreatitis recurrence

    Acute pancreatitis recurrence, irrespective of etiology

    Within 1 year after date of inclusion

Study Arms (2)

Laparoscopic cholecystectomy

EXPERIMENTAL
Procedure: Laparoscopic cholecystectomy

Watchful waiting

ACTIVE COMPARATOR
Other: Watchful waiting

Interventions

Laparoscopic cholecystectomyPROCEDURE

Laparoscopic cholecystectomy

Laparoscopic cholecystectomy
Watchful waitingOTHER

Watchful waiting

Watchful waiting

Eligibility Criteria

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

You may qualify if:

  • At least 18 years old
  • Eligible for early (laparoscopic)\* cholecystectomy
  • Full required diagnostic work-up of patient has been performed, including EUS
  • First, second or third episode of IAP, of which at least one episode characterized by a 'negative-EUS'' result
  • Informed consent for participation was obtained \*if required open cholecystectomy is allowed

You may not qualify if:

  • Patients with more than 3 episodes of acute pancreatitis
  • Diagnosis of chronic pancreatitis
  • Diagnosis of necrotizing pancreatitis
  • Current pancreatic malignancy
  • Prior cholecystectomy
  • Documented etiology of acute pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC, location University of Amsterdam

Amsterdam, North Holland, 1081 HV, Netherlands

RECRUITING

MeSH Terms

Interventions

Cholecystectomy, LaparoscopicWatchful Waiting

Intervention Hierarchy (Ancestors)

CholecystectomyBiliary Tract Surgical ProceduresDigestive System Surgical ProceduresSurgical Procedures, OperativeLaparoscopyEndoscopyMinimally Invasive Surgical ProceduresOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services Administration

Central Study Contacts

Rolf R. B. Schwarz, MD

CONTACT

+31 088-320-7052r.schwarz@amsterdamumc.nl

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, MD PhD

Study Record Dates

First Submitted

January 30, 2024

First Posted

April 30, 2024

Study Start

July 30, 2023

Primary Completion (Estimated)

July 30, 2027

Study Completion (Estimated)

July 30, 2028

Last Updated

August 3, 2026

Record last verified: 2026-07

Locations

NL(1)