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

Zhejiang University

Status: Not yet enrolling

Conditions: Pancreatic Fistula; Pancreaticoduodenal; Fistula

Treatments: Procedure: Peritoneal lavage

Study type: Interventional

Funder types: Other

Identifiers

NCT05657366

zyeyPDlavage

Details and patient eligibility

About

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.

Enrollment: 260 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

260 participants in 4 patient groups

low and medium risk（a-FRS）lavage

Experimental group

Description:

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

Treatment:

Procedure: Peritoneal lavage

low and medium risk（a-FRS） no lavage

No Intervention group

Description:

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 group

Description:

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

Treatment:

Procedure: Peritoneal lavage

high risk（a-FRS）no lavage

No Intervention group

Description:

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