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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05657366
Other study ID # zyeyPDlavage
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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;

Study Design


Related Conditions & MeSH terms


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
See also
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Recruiting NCT04380506 - Validations of New cut-of for the Stratification of Postoperative Complications,Drains Management N/A
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Completed NCT02784990 - Study of Pancreatic Enzymes in the Drains as Early Biomarkers of Post-operative Pancreatic Fistula and Its Clinical Repercussions