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

NCT04892615 — Unknown, 114 participants, Xian-Jun Yu

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

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

Registry	NCT04892615
Status	Unknown
Study type	Observational
Enrollment	114 (Estimated)
Sponsor	Xian-Jun Yu (Other)
Conditions	Safety Issues
Interventions	drainage tube was removed on 5th days after surgery., drainage tube was removed on 7th days after surgery. (Device)
Dates	start 2021-06-01 (estimated), primary completion 2024-01-30 (estimated), completion 2024-09-30 (estimated), first posted 2021-05-19, last updated 2021-05-19
Locations	1 site in China

-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).

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Cohort A		Device: drainage tube was removed on 5th days after surgery.	The drainage tube was removed on the 5th day after surgery.
Cohort B		Device: drainage tube was removed on 7th days after surgery.	The drainage tube was removed on the 7th day after surgery.

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

+Outcome measures

Primary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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.

+Locations (1)

Facility	City	Country	Status
Xianjun Fudan Yu	Shanghai, Sahnghai	China

+Investigators

Xianjun F Yu, Principal investigator, Fudan University