Investigation of Pancreaticoduodenectomy

Completed

• Conditions: Pancreaticoduodenectomy

• Registration Number: NCT03791450
• Lead Sponsor: Tongji Hospital

Brief Summary

The investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

Detailed Description

For patients with malignant or benign disease of the pancreatic head and periampullary region, pancreaticoduodenectomy is the only potential approach to radical cure. However, pancreaticoduodenectomy is consider as one of the most complex operations associated with a high rate of postoperative complications such as pancreatic fistula, delayed gastric emptying, hemorrhage, abscess, and sepsis. These complications increase the costs associated with pancreaticoduodenectomy. Numerous interventions and techniques have been introduced to decrease the morbidity. But there is little evidence for the superiority of one anastomotic technique over the others. Therefore, investigators intend to conduct a multicentre, big-sample, retrospective study to analysis the surgery results of pancreaticoduodenectomy and compare the different suture technique.

Study Timeline

• Study First Submitted: 2018-12-21
• Study First Submitted QC: 2018-12-28
• Study First Posted: 2019-01-02
• Study Start: 2019-03-01
• Primary Completion: 2019-08-01
• Study Completion: 2019-08-01
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-01
• Last Update Posted: 2020-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10085

Inclusion Criteria

Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Pancreatic Fistula(POPF)	Within 30 days after surgery	The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.

Secondary Outcome Measures

Name	Time	Method
Mortality	Within 30 days after surgery	The death occurred within 30 days after surgery
Duration of operation	Intraoperative	The time of operation count by minute.
Length of hospital stay after surgery	From first day after surgery to release from hospital (anticipate 5 days minimally)	Days between surgery and hospital discharge
Morbidity	Within 90 days after surgery	The incidence of operative complications within 90 days after surgery
Hospital costs	From first day after surgery to release from hospital (anticipate 5 days minimally)	The total hospitalization expenses

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China