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

Pancreatic Fistula Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05657366
• Other study ID #: zyeyPDlavage
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2023
• Est. completion date: June 30, 2027

Study information

• Verified date: November 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Huanbing Zhu, PhD
• Phone: 15857174159
• Email: juvanbn[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula
• Pancreaticoduodenal; Fistula

Intervention

Procedure:
• Peritoneal lavage
Continuous abdominal flushing with normal saline

Locations

Country	Name	City	State
China	The second affiliated hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative Pancreatic Fistula (POPF)	Presence of Amylase > 3 times the upper limit of normal in surgical drains	30 days post-operative
Secondary	Biliary fistula	Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out	90 days post-operative
Secondary	Post-Pancreatectomy Hemorrhage	As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates	90 days post-operative
Secondary	Mortality	Death related to surgical morbidity	90 days post-operative
Secondary	Delayed Gastric Emptying	As defined by ISGPS, grade A, B and C rates	90 days post-operative
Secondary	Abdominal abscess or infection	Collection >5cm in size, containing gas bubbles, determining systemic signs of infection	90 days post-operative
Secondary	Gastrojejunal/Duodenojejunal fistula	Fistula from gastro/duodenojejunostomy	90 days post-operative
Secondary	Wound infection	Superficial and Deep Surgical Site Incisional Infection	90 days post-operative
Secondary	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
Secondary	Reoperation	Need for new surgery due to severe morbidity	90 days post-operative
Secondary	Readmission	New admission within 30-days of discharge from hospital	30 days post-operative
Secondary	drainage tube duration	Retention time of abdominal drainage tube	90 days post-operative