NCT05657366
Not yet recruiting
Not Applicable
The Effect of Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy in Patients With Different Pancreatic Fistula Risk Scores
Second Affiliated Hospital, School of Medicine, Zhejiang University1 site in 1 country260 target enrollmentMay 1, 2023
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pancreatic Fistula
- Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Enrollment
- 260
- Locations
- 1
- Primary Endpoint
- Post-operative Pancreatic Fistula (POPF)
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preoperative diagnosis was pancreatic head, lower common bile duct, ampulla and duodenum tumors;
- •Patients with resectable tumors evaluated by imaging examination, and patients who plan to undergo pancreatoduodenectomy;
- •Subjects informed consent, understood and were willing to cooperate with the trial protocol, and signed relevant documents.
Exclusion Criteria
- •Complicated with severe liver, kidney, heart, brain, lung and other organ complications;
- •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;
- •Patients and their families do not understand the treatment implementation plan of this study;
- •Failure to complete follow-up;
Outcomes
Primary Outcomes
Post-operative Pancreatic Fistula (POPF)
Time Frame: 30 days post-operative
Presence of Amylase \> 3 times the upper limit of normal in surgical drains
Secondary Outcomes
- Wound infection(90 days post-operative)
- Post-Pancreatectomy Hemorrhage(90 days post-operative)
- Gastrojejunal/Duodenojejunal fistula(90 days post-operative)
- Reoperation(90 days post-operative)
- Biliary fistula(90 days post-operative)
- Mortality(90 days post-operative)
- Delayed Gastric Emptying(90 days post-operative)
- Abdominal abscess or infection(90 days post-operative)
- drainage tube duration(90 days post-operative)
- Length of Hospital Stay(1 year post-operative)
- Readmission(30 days post-operative)
Study Sites (1)
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