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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03791450
Other study ID # C201812
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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