Clinical trial NCT05657366: Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
Official title: The Effect of Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy in Patients With Different Pancreatic Fistula Risk Scores
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pancreatic Fistula
Pancreaticoduodenal; Fistula
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2022-12-20
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Post-operative Pancreatic Fistula (POPF)
timeFrame: 30 days post-operative
Secondary outcomes:
measure: Biliary fistula
timeFrame: 90 days post-operative
measure: Post-Pancreatectomy Hemorrhage
timeFrame: 90 days post-operative
measure: Mortality
timeFrame: 90 days post-operative
measure: Delayed Gastric Emptying
timeFrame: 90 days post-operative
measure: Abdominal abscess or infection
timeFrame: 90 days post-operative
measure: Gastrojejunal/Duodenojejunal fistula
timeFrame: 90 days post-operative
measure: Wound infection
timeFrame: 90 days post-operative
measure: Length of Hospital Stay
timeFrame: 1 year post-operative
measure: Reoperation
timeFrame: 90 days post-operative
measure: Readmission
timeFrame: 30 days post-operative
measure: drainage tube duration
timeFrame: 90 days post-operative
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The second affiliated hospital of Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: