Efficacy of Rectal Indomethacin in Prevention of Post-pan... | NCT05722548

Studies
Efficacy of Rectal Indomethacin in Prevention of Post-pancreatectomy Acute Pancreatitis

NCT05722548

Sponsor

Shanghai Jiao Tong University School of Medicine

Status

Unknown status

Last Update Posted

Feb 10, 2023Actual

Enrollment

200Estimated

Phase

Phase 2

Conditions

Pancreatectomy

Interventions

Indomethacin suppository
Standard Medical Treatment

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2023Estimated

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Feb 1, 2024Estimated

First Submitted Date

Feb 1, 2023

First Submission Date that Met QC Criteria

Feb 1, 2023

First Posted Date

Feb 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 1, 2023

Last Update Posted Date

Feb 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yingbin Liu, MD, PhD, FACS, prof., Shanghai Jiao Tong University School of MedicinePrincipal Investigator

Lead Sponsor

Shanghai Jiao Tong University School of MedicineOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 suppository Other: Standard Medical Treatment
Group B	Active Comparator	Standard Medical Treatment	Other: Standard Medical Treatment

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Indomethacin suppository	Drug	100mg of Indomethacin Suppository sigle dose at the time of induction of anesthesia	Group A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Post-pancreatectomy Acute Pancreatitis		2 weeks after pancreatectomy

Secondary Outcomes

Measure	Description	Time Frame
Pancreatic Fistula		30 days after pancreatectomy
Peripancreatic abscess		30 days after pancreatectomy
Length of hospital stay

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

*All patients planned to undergo pancreatectomy.

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yingbin Liu, PHD	Contact	+8613918803900		laoniulyb@163.com

Overall Officials

Name	Affiliation	Role
Yingbin Liu, PHD	RenJi Hospital	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided