Investigation of Pancreaticoduodenectomy

Pancreaticoduodenectomy Clinical Trial

Official title:

A Multicenter Big⁃Sample Retrospective Study of Pancreaticoduodenectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03791450
• Other study ID #: C201812
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: August 1, 2019

Study information

• Verified date: March 2020
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10085
• Est. completion date: August 1, 2019
• Est. primary completion date: August 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.

Exclusion Criteria:

None

Related Conditions & MeSH terms

• Pancreaticoduodenectomy

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of Postoperative Pancreatic Fistula(POPF)	The frequency of POPF occurs and the POPF will be strictly diagnosis and classified according to IGSPF criteria.	Within 30 days after surgery
Secondary	Morbidity	The incidence of operative complications within 90 days after surgery	Within 90 days after surgery
Secondary	Mortality	The death occurred within 30 days after surgery	Within 30 days after surgery
Secondary	Duration of operation	The time of operation count by minute.	Intraoperative
Secondary	Length of hospital stay after surgery	Days between surgery and hospital discharge	From first day after surgery to release from hospital (anticipate 5 days minimally)
Secondary	Hospital costs	The total hospitalization expenses	From first day after surgery to release from hospital (anticipate 5 days minimally)