NCT05722548

Brief Summary

The purpose of this study is to evaluate the efficacy of rectal indomethacin in prevention of post-pancreatectomy acute pancreatitis.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_2

Status
unknown

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

First Submitted

Initial submission to the registry

February 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 10, 2023

Status Verified

January 1, 2023

Enrollment Period

11 months

First QC Date

February 1, 2023

Last Update Submit

February 1, 2023

Conditions

Pancreatectomy

Outcome Measures

Primary Outcomes (1)

  • Post-pancreatectomy Acute Pancreatitis

    2 weeks after pancreatectomy

Secondary Outcomes (3)

  • Pancreatic Fistula

    30 days after pancreatectomy

  • Peripancreatic abscess

    30 days after pancreatectomy

  • Length of hospital stay

    30 days after pancreatectomy

Study Arms (2)

Group A

EXPERIMENTAL

Patients will be administered 100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia with Standard Medical Treatment

Drug: Indomethacin suppositoryOther: Standard Medical Treatment

Group B

ACTIVE COMPARATOR

Standard Medical Treatment

Other: Standard Medical Treatment

Interventions

Indomethacin suppositoryDRUG

100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia

Group A
Standard Medical TreatmentOTHER

Standard Medical Treatment

Group AGroup B

Eligibility Criteria

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

You may qualify if:

  • \*All patients planned to undergo pancreatectomy.

You may not qualify if:

  • asthma
  • allergic reactions to NSAIDs
  • CKD
  • internal hemorrhoids
  • anti-platelet medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yingbin Liu, PHD

    RenJi Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yingbin Liu, PHD

CONTACT

+8613918803900laoniulyb@163.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
prof.

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

February 1, 2023

Primary Completion

December 31, 2023

Study Completion

February 1, 2024

Last Updated

February 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share