NCT06031363

Brief Summary

This study is a single-center, randomized, single-blind, parallel controlled clinical study to explore the optimal dose of postoperative indomethacin suppository for the prevention of post-ERCP pancreatitis. The purpose of this study is to explore the optimal dosage of indomethacin suppository for PEP prevention, to study the control effect of indomethacin on hyperamylaseemia, and to further explore the group of patients who benefit most from this therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 11, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

1.1 years

First QC Date

September 2, 2023

Last Update Submit

March 13, 2024

Conditions

PancreatitisCholangiopancreatography, Endoscopic RetrogradeIndomethacin

Keywords

Indomethacin SuppositoryPost-ERCP Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • serum amylase concentration

    blood test

    before operation, 3 hours after operation, 24 hours after operation, 48 hours after operation

Secondary Outcomes (3)

  • incidence of post-ERCP pancreatitis

    3rd day after operation

  • incidence of hyperamylaseemia

    3rd day after operation

  • incidence of indomethacin adverse reaction events

    3rd day after operation

Study Arms (3)

Regular dosage group

ACTIVE COMPARATOR

Give indomethacin suppository 100mg anal plug immediately after operation.

Drug: Indomethacin Suppository

Low dosage group

EXPERIMENTAL

Give indomethacin suppository 50mg anal plug immediately after operation.

Drug: Indomethacin Suppository

High dosage group

EXPERIMENTAL

Give indomethacin suppository 150mg anal plug immediately after operation.

Drug: Indomethacin Suppository

Interventions

Indomethacin SuppositoryDRUG

Patients in the regular dose group are given indomethacin suppository 100 mg anal plug immediately after operation, patients in the low dose group are given indomethacin suppository 50 mg anal plug immediately after operation, and patients in the high dose group are given indomethacin suppository 150 mg anal plug immediately after operation.

Also known as: Indomethacin
High dosage groupLow dosage groupRegular dosage group

Eligibility Criteria

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

You may qualify if:

  • According to the "Chinese ERCP Guidelines (2018 Edition)", patients with various biliary and pancreatic diseases who have indications for ERCP examination and treatment, who are at least 18 years old and have no contraindications, and who can tolerate the examination;
  • Preoperative blood coagulation function, liver and kidney function indicators are in the normal range;
  • The patients agreed to participate in this experiment, signed the informed consent form, and was approved by the hospital ethics committee.

You may not qualify if:

  • Contraindications to indomethacin and other NSAIDs: such as allergy to indomethacin, severe heart failure, active peptic ulcer/bleeding, perioperative period of coronary artery bypass surgery, etc.;
  • There are severe cardiovascular and cerebrovascular diseases, respiratory insufficiency and coagulation dysfunction, etc., and cannot tolerate ERCP examination;
  • Those who have recently used indomethacin and other non-steroidal anti-infective drugs;
  • Pregnant or lactating women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

MeSH Terms

Conditions

Pancreatitis

Interventions

Indomethacin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

IndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Rui Li, Dr.

    The First Affiliated Hospital of Soochow University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of the Department of Gastroenterology

Study Record Dates

First Submitted

September 2, 2023

First Posted

September 11, 2023

Study Start

November 1, 2022

Primary Completion

December 6, 2023

Study Completion

January 31, 2024

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

CN(1)