NCT05657366

Brief Summary

As one of the possible strategies to prevent pancreatic fistula, peritoneal lavage is still widely used in clinical practice, but it lacks more evidence of evidence-based medicine and recommendations of guidelines. Some clinicians believe that routine flushing after pancreatoduodenectomy wastes medical resources and has a negative impact on patients' comfort. In this study, the investigators designed a multicenter prospective controlled trial to compare the effects of peritoneal lavage and natural drainage on the incidence of pancreatic fistula and related complications after pancreatoduodenectomy. To study the indications of peritoneal lavage.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
260

participants targeted

Target at P75+ for not_applicable

Timeline
14mo left

Started May 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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 Progress73%
May 2023Jun 2027

First Submitted

Initial submission to the registry

November 7, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 20, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

April 21, 2023

Status Verified

November 1, 2022

Enrollment Period

3.7 years

First QC Date

November 7, 2022

Last Update Submit

April 20, 2023

Conditions

Pancreatic FistulaPancreaticoduodenal; Fistula

Outcome Measures

Primary Outcomes (1)

  • Post-operative Pancreatic Fistula (POPF)

    Presence of Amylase \> 3 times the upper limit of normal in surgical drains

    30 days post-operative

Secondary Outcomes (11)

  • Biliary fistula

    90 days post-operative

  • Post-Pancreatectomy Hemorrhage

    90 days post-operative

  • Mortality

    90 days post-operative

  • Delayed Gastric Emptying

    90 days post-operative

  • Abdominal abscess or infection

    90 days post-operative

  • +6 more secondary outcomes

Study Arms (4)

low and medium risk（a-FRS）lavage

EXPERIMENTAL

alternative pancreatic fistula risk score system，a-FRS Low risk group (0\~5%), medium risk group (\>5%\~20%), lavage

Procedure: Peritoneal lavage

low and medium risk（a-FRS） no lavage

NO INTERVENTION

alternative pancreatic fistula risk score system，a-FRS Low risk group (0\~5%), medium risk group (\>5%\~20%), no lavage

high risk（a-FRS）lavage

EXPERIMENTAL

alternative pancreatic fistula risk score system，a-FRS high risk group (\>20%) lavage

Procedure: Peritoneal lavage

high risk（a-FRS）no lavage

NO INTERVENTION

alternative pancreatic fistula risk score system，a-FRS high risk group (\>20%) no lavage

Interventions

Peritoneal lavagePROCEDURE

Continuous abdominal flushing with normal saline

high risk（a-FRS）lavagelow and medium risk（a-FRS）lavage

Eligibility Criteria

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

You may qualify if:

  • Preoperative diagnosis was pancreatic head, lower common bile duct, ampulla and duodenum tumors;
  • Patients with resectable tumors evaluated by imaging examination, and patients who plan to undergo pancreatoduodenectomy;
  • Subjects informed consent, understood and were willing to cooperate with the trial protocol, and signed relevant documents.

You may not qualify if:

  • Complicated with severe liver, kidney, heart, brain, lung and other organ complications;
  • Intraoperative changes in surgical methods, such as patients with tumor dissemination and only abdominal opening and closing; Or it needs to be resected in combination with other organs;
  • Patients and their families do not understand the treatment implementation plan of this study;
  • Failure to complete follow-up;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The second affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Pancreatic FistulaFistula

Interventions

Peritoneal Lavage

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesPancreatic DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutic IrrigationInvestigative Techniques

Central Study Contacts

Huanbing Zhu, PhD

CONTACT

15857174159juvanbn@zju.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2022

First Posted

December 20, 2022

Study Start

May 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2027

Last Updated

April 21, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL

Locations

CN(1)