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

NCT ID: NCT05657366

Last Updated: 2023-04-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2027-06-30

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.

Conditions

Pancreatic Fistula; Pancreaticoduodenal; Fistula

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Peritoneal lavage

Intervention Type: PROCEDURE

Continuous abdominal flushing with normal saline

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

high risk（a-FRS）lavage

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

Group Type: EXPERIMENTAL

Peritoneal lavage

Intervention Type: PROCEDURE

Continuous abdominal flushing with normal saline

high risk（a-FRS）no lavage

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Peritoneal lavage

Continuous abdominal flushing with normal saline

Intervention Type: PROCEDURE

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The second affiliated hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Huanbing Zhu, PhD

Role: CONTACT

juvanbn@zju.edu.cn

15857174159

Other Identifiers

zyeyPDlavage

Identifier Type: -

Identifier Source: org_study_id