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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05687825
Other study ID # SVU/MED/SUR011/4/23/4/612
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 1, 2017
Est. completion date July 30, 2022

Study information

Verified date July 2023
Source South Valley University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.


Description:

For periampullary and pancreatic head disorders, pancreaticoduodenectomy (PD) is the standard treatment. However, PD is technically demanding and has high morbidity and mortality rates. The most significant and life-threatening complication of PD is postoperative pancreatic fistula (POPF), with reported rates of 5 to 70% for total POPF and 10 to 45% for clinically relevant (CR-POPF). Operative risk variables for CR-POPF after PD were investigated in this study.


Recruitment information / eligibility

Status Completed
Enrollment 107
Est. completion date July 30, 2022
Est. primary completion date July 30, 2022
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria: 1. Patients with resectable distal CBD carcinoma, periampullary carcinoma, duodenal carcinoma, and carcinoma of the head of the pancreas. 2. American Society of Anesthesiologists (ASA) scores I & II. 3. Patients aged > 20 years. 4. Agreement to complete the study. Exclusion Criteria: 1. Patients with benign disease, trauma, and receive neoadjuvant therapy. 2. double primary cancers.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
pancreaticoduodenectomy procedure
Pancreaticoduodenectomy operation

Locations

Country Name City State
Egypt Qena faculty of Medicine, South Valley University Cairo

Sponsors (1)

Lead Sponsor Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary clinically relevant post operative pancreatic fistula A drainage fluid of any measurable volume with an amylase level more than three times the upper normal serum level on or after the 3rd postoperative day 10 days
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