Pancreatic Fistula, Pancreaticoduodenal; Fistula
Conditions
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.
Interventions
PROCEDUREPeritoneal lavage
Continuous abdominal flushing with normal saline
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pancreatic Fistula (POPF) | 30 days post-operative | Presence of Amylase \> 3 times the upper limit of normal in surgical drains |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-Pancreatectomy Hemorrhage | 90 days post-operative | As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates |
| 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 |
| Gastrojejunal/Duodenojejunal fistula | 90 days post-operative | Fistula from gastro/duodenojejunostomy |
| Biliary fistula | 90 days post-operative | Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out |
| 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 |
| Reoperation | 90 days post-operative | Need for new surgery due to severe morbidity |
| Readmission | 30 days post-operative | New admission within 30-days of discharge from hospital |
| drainage tube duration | 90 days post-operative | Retention time of abdominal drainage tube |
| Wound infection | 90 days post-operative | Superficial and Deep Surgical Site Incisional Infection |
Countries
China
Contacts
Primary ContactHuanbing Zhu, PhD
Outcome results
None listed