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Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy

ConditionsPancreatic FistulaPancreaticoduodenal; Fistula
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Peritoneal lavage

    Procedure/Surgery

    Continuous abdominal flushing with normal saline

Treatment groups

260 Participants
are divided into 4 treatment groups
Group A: low and medium risk（a-FRS）lavageExperimental treatment 1 intervention
Group B: low and medium risk（a-FRS） no lavageNo intervention 0 interventions
Group C: high risk（a-FRS）lavageExperimental treatment 1 intervention
Group D: high risk（a-FRS）no lavageNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Post-operative Pancreatic Fistula (POPF)

Presence of Amylase \> 3 times the upper limit of normal in surgical drains

Time frame
30 days post-operative

Secondary outcomes

1

Biliary fistula

Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out

Time frame
90 days post-operative
2

Post-Pancreatectomy Hemorrhage

As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates

Time frame
90 days post-operative
3

Mortality

Death related to surgical morbidity

Time frame
90 days post-operative
4

Delayed Gastric Emptying

As defined by ISGPS, grade A, B and C rates

Time frame
90 days post-operative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: