Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
216 participants
INTERVENTIONAL
2020-06-04
2024-09-11
Brief Summary
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Detailed Description
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Hypothesis: in patients with resectable pancreatic and periampullary tumors, performing a Blumgart (AB) anastomosis for pancreatoenteric reconstruction after duodenopancreatectomy decreases the rate of postoperative pancreatic fistula (PPF) compared to to pancreatogastric anastomosis.
Main goal: To comparatively evaluate the rate of PPF in patients with pancreatic and periampullary tumors undergoing cephalic duodenopancreatectomy after reconstruction with Blumgart anastomosis or pancreatogastric anastomosis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Pancreatogastric anastomosis.
Pancreatogastric anastomosis.
Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Pancreatogastric anastomosis.
Blumgart Anastomosis
Blumgart Anastomosis
Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Blumgart anastomosis
Interventions
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Blumgart Anastomosis
Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Blumgart anastomosis
Pancreatogastric anastomosis.
Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Pancreatogastric anastomosis.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of pancreatic and periampullary tumor pathology that requires pancreatoduodenectomy
* Signature of informed consent by the patient or his legal representative
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Instituto de Salud Carlos III
OTHER_GOV
Fundación para la Investigación del Hospital Clínico de Valencia
OTHER
Responsible Party
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Locations
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Hospital Clínico Universitario de Valencia
Valencia, , Spain
Countries
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Other Identifiers
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PANGASBLUM
Identifier Type: -
Identifier Source: org_study_id
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