he Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery

The Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery ： Results of a Prospective Randomized Clinical Trial

Randomized, open, single-center, controlled prospective studies were designed to obtain reliable level I evidence in evidence-based medicine.Based on the premise of at least a 6-fold reduction in pancreatic fistula, as observed by Kawai et al after early drainage.Considering the overall incidence of pancreatic fistula after standard pancreatectomy at our center (approximately 20%), we would expect this complication to occur in approximately 3.4% of cases in Group A.α was set as 0.05 and β was set as 0.2 (efficacy was 80%), indicating that the total number of study subjects was at least 114 patients (at least 57 patients in the experimental group and 57 patients in the control group).

Study Overview

• Status: Not yet recruiting
• Conditions: Safety Issues
• Intervention / Treatment: Device: drainage tube was removed on 5th days after surgery.; Device: drainage tube was removed on 7th days after surgery.

• Study Type: Observational
• Enrollment (Anticipated): 114

Contacts and Locations

• Study Contact: Name: Xianjun F Yu; Phone Number: 18019112906; Email: yuxianjun@fudanpci.org

Study Locations

• China
  • Sahnghai
    • Shanghai, Sahnghai, China
      • Xianjun Fudan Yu
      • Contact: Xianjun F Yu; Phone Number: 18019112906; Email: yuxianjun@fudanpci.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Prepare for elective pancreatic surgery, including laparoscopic or open pancreaticoduodenectomy and distal pancreaticocaudal body resection;

Description

Inclusion Criteria:

• ECOG 0-2;
• The amylase value in the drainage tube of patients receiving pancreaticoduodenectomy or distal pancreatectomy was lower than 5000 IU/L on the first day after surgery;
• postoperative drainage tube placement;
• Patients with no obvious contraindication to surgery;
• Expected postoperative survival ≥3 months;

Exclusion Criteria:

• Pancreaticoduodenectomy and pancreaticogastric anastomosis were performed;
• Suspicion or abdominal bleeding within 5 days after surgery;
• suspected biliary and intestinal fistula within 5 days after operation;
• On the fifth day after the operation, abdominal CT reexamination showed local effusion with a depth greater than 3cm.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort A; The drainage tube was removed on the 5th day after surgery.	Device: drainage tube was removed on 5th days after surgery.; drainage tube was removed on 5th days after surgery.
Cohort B; The drainage tube was removed on the 7th day after surgery.	Device: drainage tube was removed on 7th days after surgery.; drainage tube was removed on 7th days after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The incidence of postoperative pancreatic fistula and abdominal infection;	3month
Severity of complications (duration of postoperative hospital stay) was assessed by Dindo Clavien classification.	3month

Collaborators and Investigators

• Sponsor: Xian-Jun Yu
• Investigators: Principal Investigator: Xianjun F Yu, Fudan University

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2021
• Primary Completion (Anticipated): January 30, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: May 15, 2021
• First Submitted That Met QC Criteria: May 15, 2021
• First Posted (Actual): May 19, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2021
• Last Update Submitted That Met QC Criteria: May 15, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CSPAC-34

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No