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

NCT04892615 | Unknown

• 1 other identifier: CSPAC-34
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 1

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).

Conditions

Safety Issues

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cohort A

The drainage tube was removed on the 5th day after surgery.

Device: 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.

Interventions

drainage tube was removed on 5th days after surgery. DEVICE

drainage tube was removed on 5th days after surgery.

Cohort A

drainage tube was removed on 7th days after surgery. DEVICE

drainage tube was removed on 7th days after surgery.

Cohort B

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xian-Jun Yu: lead

Study Sites (1)

Xianjun Fudan Yu

Shanghai, Sahnghai, China

Location

Study Officials

• Xianjun F Yu

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianjun F Yu

CONTACT

18019112906; yuxianjun@fudanpci.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President of Pancreatic Cancer Institute

Study Record Dates

• First Submitted: May 15, 2021
• First Posted: May 19, 2021
• Study Start: June 1, 2021
• Primary Completion: January 30, 2024
• Study Completion: September 30, 2024
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

CN (1)