Second Affiliated Hospital, Zhejiang University, School of Medicine
Phase
Not applicable
Started
2023-05-01
Last updated
2023-04-21
Condition(s) studied
Pancreatic FistulaPancreaticoduodenal; Fistula
Investigational drug(s) / intervention(s)
Peritoneal lavage
Peritoneal lavage: Continuous abdominal flushing with normal saline
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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;
Primary outcome measure(s)
Post-operative Pancreatic Fistula (POPF) — 30 days post-operative Presence of Amylase \> 3 times the upper limit of normal in surgical drains
Trial sites (1)
Facility
City
Region
Status
The second affiliated hospital of Zhejiang University School of Medicine
Hangzhou
Zhejiang
More Second Affiliated Hospital, Zhejiang University, School of Medicine trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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