Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05657366

Collaborator

(none)

260

Enrollment

Location

Arms

53.9

Anticipated Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Fistula Pancreaticoduodenal; Fistula	Procedure: Peritoneal lavage	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

The Effect of Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy in Patients With Different Pancreatic Fistula Risk Scores

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2026

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low and medium risk（a-FRS）lavage alternative pancreatic fistula risk score system，a-FRS Low risk group (0~5%), medium risk group (>5%~20%), lavage	Procedure: Peritoneal lavage Continuous abdominal flushing with normal saline
No Intervention: low and medium risk（a-FRS） no lavage alternative pancreatic fistula risk score system，a-FRS Low risk group (0~5%), medium risk group (>5%~20%), no lavage
Experimental: high risk（a-FRS）lavage alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) lavage	Procedure: Peritoneal lavage Continuous abdominal flushing with normal saline
No Intervention: high risk（a-FRS）no lavage alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) no lavage

Outcome Measures

Primary Outcome Measures

Post-operative Pancreatic Fistula (POPF) [30 days post-operative]
Presence of Amylase > 3 times the upper limit of normal in surgical drains

Secondary Outcome Measures

Biliary fistula [90 days post-operative]
Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out
Post-Pancreatectomy Hemorrhage [90 days post-operative]
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Mortality [90 days post-operative]
Death related to surgical morbidity
Delayed Gastric Emptying [90 days post-operative]
As defined by ISGPS, grade A, B and C rates
Abdominal abscess or infection [90 days post-operative]
Collection >5cm in size, containing gas bubbles, determining systemic signs of infection
Gastrojejunal/Duodenojejunal fistula [90 days post-operative]
Fistula from gastro/duodenojejunostomy
Wound infection [90 days post-operative]
Superficial and Deep Surgical Site Incisional Infection
Length of Hospital Stay [1 year post-operative]
calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission
Reoperation [90 days post-operative]
Need for new surgery due to severe morbidity
Readmission [30 days post-operative]
New admission within 30-days of discharge from hospital
drainage tube duration [90 days post-operative]
Retention time of abdominal drainage tube

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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.

Exclusion Criteria:

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;

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The second affiliated hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

Second Affiliated Hospital, School of Medicine, Zhejiang University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Second Affiliated Hospital, School of Medicine, Zhejiang University

ClinicalTrials.gov Identifier:

NCT05657366

Other Study ID Numbers:

zyeyPDlavage

First Posted:

Dec 20, 2022

Last Update Posted:

Dec 20, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pancreatic Fistula

Fistula

Study Results

No Results Posted as of Dec 20, 2022