Back to resultsPeritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
Primary Purpose
Pancreatic Fistula, Pancreaticoduodenal; Fistula
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Peritoneal lavage
Sponsored by
About this trial
This is an interventional treatment trial for Pancreatic Fistula
Eligibility Criteria
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;
Sites / Locations
- The second affiliated hospital of Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
Experimental
No Intervention
Arm Label
low and medium risk（a-FRS）lavage
low and medium risk（a-FRS） no lavage
high risk（a-FRS）lavage
high risk（a-FRS）no lavage
Arm Description
alternative pancreatic fistula risk score system，a-FRS Low risk group (0~5%), medium risk group (>5%~20%), lavage
alternative pancreatic fistula risk score system，a-FRS Low risk group (0~5%), medium risk group (>5%~20%), no lavage
alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) lavage
alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) no lavage
Outcomes
Primary Outcome Measures
Post-operative Pancreatic Fistula (POPF)
Presence of Amylase > 3 times the upper limit of normal in surgical drains
Secondary Outcome Measures
Biliary fistula
Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out
Post-Pancreatectomy Hemorrhage
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Mortality
Death related to surgical morbidity
Delayed Gastric Emptying
As defined by ISGPS, grade A, B and C rates
Abdominal abscess or infection
Collection >5cm in size, containing gas bubbles, determining systemic signs of infection
Gastrojejunal/Duodenojejunal fistula
Fistula from gastro/duodenojejunostomy
Wound infection
Superficial and Deep Surgical Site Incisional Infection
Length of Hospital Stay
calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission
Reoperation
Need for new surgery due to severe morbidity
Readmission
New admission within 30-days of discharge from hospital
drainage tube duration
Retention time of abdominal drainage tube
Full Information
NCT ID
NCT05657366
First Posted
November 7, 2022
Last Updated
April 20, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT05657366
Brief Title
Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Fistula, Pancreaticoduodenal; Fistula
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
low and medium risk（a-FRS）lavage
Arm Type
Experimental
Arm Description
alternative pancreatic fistula risk score system，a-FRS Low risk group (0~5%), medium risk group (>5%~20%), lavage
Arm Title
low and medium risk（a-FRS） no lavage
Arm Type
No Intervention
Arm Description
alternative pancreatic fistula risk score system，a-FRS Low risk group (0~5%), medium risk group (>5%~20%), no lavage
Arm Title
high risk（a-FRS）lavage
Arm Type
Experimental
Arm Description
alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) lavage
Arm Title
high risk（a-FRS）no lavage
Arm Type
No Intervention
Arm Description
alternative pancreatic fistula risk score system，a-FRS high risk group (>20%) no lavage
Intervention Type
Procedure
Intervention Name(s)
Peritoneal lavage
Intervention Description
Continuous abdominal flushing with normal saline
Primary Outcome Measure Information:
Title
Post-operative Pancreatic Fistula (POPF)
Description
Presence of Amylase > 3 times the upper limit of normal in surgical drains
Time Frame
30 days post-operative
Secondary Outcome Measure Information:
Title
Biliary fistula
Description
Output of bile from drains on or by POD 3, pancreaticojejunostomy leak should be ruled out
Time Frame
90 days post-operative
Title
Post-Pancreatectomy Hemorrhage
Description
As defined by the International Study Group for Pancreatic Surgery (ISGPS), grade A, B and C rates
Time Frame
90 days post-operative
Title
Mortality
Description
Death related to surgical morbidity
Time Frame
90 days post-operative
Title
Delayed Gastric Emptying
Description
As defined by ISGPS, grade A, B and C rates
Time Frame
90 days post-operative
Title
Abdominal abscess or infection
Description
Collection >5cm in size, containing gas bubbles, determining systemic signs of infection
Time Frame
90 days post-operative
Title
Gastrojejunal/Duodenojejunal fistula
Description
Fistula from gastro/duodenojejunostomy
Time Frame
90 days post-operative
Title
Wound infection
Description
Superficial and Deep Surgical Site Incisional Infection
Time Frame
90 days post-operative
Title
Length of Hospital Stay
Description
calculated from the day of surgery to the day of discharge, adding up the days after a possible re-admission
Time Frame
1 year post-operative
Title
Reoperation
Description
Need for new surgery due to severe morbidity
Time Frame
90 days post-operative
Title
Readmission
Description
New admission within 30-days of discharge from hospital
Time Frame
30 days post-operative
Title
drainage tube duration
Description
Retention time of abdominal drainage tube
Time Frame
90 days post-operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Huanbing Zhu, PhD
Phone
15857174159
Email
juvanbn@zju.edu.cn
Facility Information:
Facility Name
The second affiliated hospital of Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Peritoneal Lavage on the Incidence of Pancreatic Fistula and Related Complications After Pancreatoduodenectomy
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