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

Sponsor
Xian-Jun Yu (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04892615
Collaborator
(none)
114
Enrollment
1
Location
40
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Device: drainage tube was removed on 5th days after surgery.
  • Device: drainage tube was removed on 7th days after surgery.

Study Design

Study Type:
Observational
Anticipated Enrollment :
114 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Safety Research of Timing of the Removal of Abdominal Drains After Pancreatic Surgery ： Results of a Prospective Randomized Clinical Trial
Anticipated Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jan 30, 2024
Anticipated Study Completion Date :
Sep 30, 2024

Arms and Interventions

Arm 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.

Outcome Measures

Primary Outcome Measures

  1. The incidence of postoperative pancreatic fistula and abdominal infection; [3month]

  2. Severity of complications (duration of postoperative hospital stay) was assessed by Dindo Clavien classification. [3month]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Xianjun Fudan Yu Shanghai Sahnghai China

Sponsors and Collaborators

  • Xian-Jun Yu

Investigators

  • Principal Investigator: Xianjun F Yu, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Xian-Jun Yu, President of Pancreatic Cancer Institute, Fudan University
ClinicalTrials.gov Identifier:
NCT04892615
Other Study ID Numbers:
  • CSPAC-34
First Posted:
May 19, 2021
Last Update Posted:
May 19, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 19, 2021