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

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy in Patients With Different Pancreatic Fistula Risk Scores

Conditions
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Pancreatic Fistula, Pancreaticoduodenal; Fistula

Intervention / Treatment
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* Procedure: Peritoneal lavage


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low and medium risk（a-FRS）lavage<br>alternative pancreatic fistula risk score system，a-FRS Low risk group (0 5%), medium risk group (>5% 20%), lavage | Procedure: Peritoneal lavage<br>* Continuous abdominal flushing with normal saline<br>|
| No Intervention: low and medium risk（a-FRS） no lavage<br>alternative pancreatic fistula risk score system，a-FRS Low risk group (0 5%), medium risk group (>5% 20%), no lavage | |
| Experimental: high risk（a-FRS）lavage<br>alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) lavage | Procedure: Peritoneal lavage<br>* Continuous abdominal flushing with normal saline<br>|
| No Intervention: high risk（a-FRS）no lavage<br>alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) no lavage | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Pancreatic Fistula (POPF) | Presence of Amylase > 3 times the upper limit of normal in surgical drains | 30 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biliary fistula | Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out | 90 days post-operative | 
| Post-Pancreatectomy Hemorrhage | As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates | 90 days post-operative | 
| Mortality | Death related to surgical morbidity | 90 days post-operative | 
| Delayed Gastric Emptying | As defined by ISGPS, grade A, B and C rates | 90 days post-operative | 
| Abdominal abscess or infection | Collection >5cm in size, containing gas bubbles, determining systemic signs of infection | 90 days post-operative | 
| Gastrojejunal/Duodenojejunal fistula | Fistula from gastro/duodenojejunostomy | 90 days post-operative | 
| Wound infection | Superficial and Deep Surgical Site Incisional Infection | 90 days post-operative | 
| Length of Hospital Stay | calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission | 1 year post-operative | 
| Reoperation | Need for new surgery due to severe morbidity | 90 days post-operative | 
| Readmission | New admission within 30-days of discharge from hospital | 30 days post-operative | 
| drainage tube duration | Retention time of abdominal drainage tube | 90 days post-operative |