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

Safety Issues Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04892615
• Other study ID #: CSPAC-34
• Status: Not yet recruiting
• Start date: June 1, 2021
• Est. completion date: September 30, 2024

Study information

• Verified date: May 2021
• Source: Fudan University
• Contact: Xianjun F Yu
• Phone: 18019112906
• Email: yuxianjun[@]fudanpci.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 114
• Est. completion date: September 30, 2024
• Est. primary completion date: January 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Safety Issues

Intervention

Device:
• drainage tube was removed on 5th days after surgery.
drainage tube was removed on 5th days after surgery.
• drainage tube was removed on 7th days after surgery.
drainage tube was removed on 7th days after surgery.

Locations

Country	Name	City	State
China	Xianjun Fudan Yu	Shanghai	Sahnghai

Sponsors (1)

Lead Sponsor	Collaborator
Xian-Jun Yu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of postoperative pancreatic fistula and abdominal infection;		3month
Primary	Severity of complications (duration of postoperative hospital stay) was assessed by Dindo Clavien classification.		3month