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

N/ANot Yet RecruitingNCT05657366

Second Affiliated Hospital, School of Medicine, Zhejiang University260 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

260

Conditions

Pancreatic Fistula Pancreaticoduodenal; Fistula

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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;

Outcomes

Primary Outcomes

Post-operative Pancreatic Fistula (POPF)

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

Time frame: 30 days post-operative