Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
- Conditions
- Pancreatic FistulaPancreaticoduodenal; Fistula
- Interventions
- Procedure: Peritoneal lavage
- Registration Number
- NCT05657366
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 260
- 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.
- 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;
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description low and medium risk（a-FRS）lavage Peritoneal lavage alternative pancreatic fistula risk score system，a-FRS Low risk group (0\~5%), medium risk group (\>5%\~20%), lavage high risk（a-FRS）lavage Peritoneal lavage alternative pancreatic fistula risk score system，a-FRS high risk group (\>20%) lavage
- Primary Outcome Measures
Name Time Method Post-operative Pancreatic Fistula (POPF) 30 days post-operative Presence of Amylase \> 3 times the upper limit of normal in surgical drains
- Secondary Outcome Measures
Name Time Method Wound infection 90 days post-operative Superficial and Deep Surgical Site Incisional Infection
Post-Pancreatectomy Hemorrhage 90 days post-operative As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Gastrojejunal/Duodenojejunal fistula 90 days post-operative Fistula from gastro/duodenojejunostomy
Reoperation 90 days post-operative Need for new surgery due to severe morbidity
Biliary fistula 90 days post-operative Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out
Mortality 90 days post-operative Death related to surgical morbidity
Delayed Gastric Emptying 90 days post-operative As defined by ISGPS, grade A, B and C rates
Abdominal abscess or infection 90 days post-operative Collection \>5cm in size, containing gas bubbles, determining systemic signs of infection
drainage tube duration 90 days post-operative Retention time of abdominal drainage tube
Length of Hospital Stay 1 year post-operative calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission
Readmission 30 days post-operative New admission within 30-days of discharge from hospital
Trial Locations
- Locations (1)
The second affiliated hospital of Zhejiang University School of Medicine
🇨🇳Hangzhou, Zhejiang, China