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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pancreatic Fistula; Pancreaticoduodenal; Fistula
• Intervention / Treatment: Procedure: Peritoneal lavage

• Study Type: Interventional
• Enrollment (Anticipated): 260
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Huanbing Zhu, PhD; Phone Number: 15857174159; Email: juvanbn@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • The Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Complicated with severe liver, kidney, heart, brain, lung and other organ complications;
2. 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;
3. Patients and their families do not understand the treatment implementation plan of this study;
4. Failure to complete follow-up;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pancreatic Fistula (POPF)	Presence of Amylase > 3 times the upper limit of normal in surgical drains	30 days post-operative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): December 31, 2026
• Study Completion (Anticipated): June 30, 2027

Study Registration Dates

• First Submitted: November 7, 2022
• First Submitted That Met QC Criteria: December 18, 2022
• First Posted (Actual): December 20, 2022

Study Record Updates

• Last Update Posted (Actual): April 21, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathological Conditions, Anatomical; Pancreatic Diseases; Digestive System Fistula; Fistula; Pancreatic Fistula
• Other Study ID Numbers: zyeyPDlavage

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No