Status:
COMPLETED
Pancreatic Anastomosis After Duodenopancreatectomy
Lead Sponsor:
Fundación para la Investigación del Hospital Clínico de Valencia
Collaborating Sponsors:
Instituto de Salud Carlos III
Conditions:
Pancreatic Anastomotic Leak
Pancreatic Neoplasms
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart anastomosis).
Detailed Description
Background: Postoperative pancreatic fistula is currently the most frequent complications after duodenopancreatectomy. There are currently no RCT comparing two of the most frequently used method of pa...
Eligibility Criteria
Inclusion
- Patients over 18 years old.
- Diagnosis of pancreatic and periampullary tumor pathology that requires pancreatoduodenectomy
- Signature of informed consent by the patient or his legal representative
Exclusion
- Patients in whom liver metastases or peritoneal carcinomatosis are detected during surgery.
- Patients in whom tumor resection is ultimately not achieved due to intraoperative evidence that the tumor is locally advanced, unresectable.
- Patients with macroscopic residual tumor (R2).
- High risk patients with severe pathology (ASA IV) according to the American Association of Anesthetists.
Key Trial Info
Start Date :
June 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 11 2024
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04462354
Start Date
June 4 2020
End Date
September 11 2024
Last Update
October 21 2024
Active Locations (1)
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1
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010