Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Peritoneal lavage.
- Who it may be relevant to
- Registry conditions: Pancreatic Fistula, Pancreaticoduodenal; Fistula. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
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.
Interventions
- Procedure Peritoneal lavage
Continuous abdominal flushing with normal saline
Primary outcome measures
- Post-operative Pancreatic Fistula (POPF) [Time frame: 30 days post-operative]
Secondary outcome measures (11)
- Biliary fistula [Time frame: 90 days post-operative]
- Post-Pancreatectomy Hemorrhage [Time frame: 90 days post-operative]
- Mortality [Time frame: 90 days post-operative]
- Delayed Gastric Emptying [Time frame: 90 days post-operative]
- Abdominal abscess or infection [Time frame: 90 days post-operative]
- Gastrojejunal/Duodenojejunal fistula [Time frame: 90 days post-operative]
- Wound infection [Time frame: 90 days post-operative]
- Length of Hospital Stay [Time frame: 1 year post-operative]
- Reoperation [Time frame: 90 days post-operative]
- Readmission [Time frame: 30 days post-operative]
- drainage tube duration [Time frame: 90 days post-operative]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The second affiliated hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT05657366 · zyeyPDlavage