Investigation of Pancreaticoduodenectomy

A Multicenter Big⁃Sample Retrospective Study of Pancreaticoduodenectomy

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03791450

Enrollment

10085

Registered

2019-01-02

Start date

2019-03-01

Completion date

2019-08-01

Last updated

2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreaticoduodenectomy

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

Patients who had underwent pancreaticoduodenectomy between 2008 to 2018.

Exclusion criteria

None

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Morbidity	Within 90 days after surgery	The incidence of operative complications within 90 days after surgery
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
Hospital costs	From first day after surgery to release from hospital (anticipate 5 days minimally)	The total hospitalization expenses

Countries

China

Outcome results