Pancreatic Anastomosis After Duodenopancreatectomy
PANGASBLUM
1 other identifier
interventional
216
1 country
1
Brief Summary
A national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart anastomosis).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 4, 2020
CompletedFirst Submitted
Initial submission to the registry
July 3, 2020
CompletedFirst Posted
Study publicly available on registry
July 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 11, 2024
CompletedOctober 21, 2024
October 1, 2024
4.3 years
July 3, 2020
October 18, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Postoperative pancreatic fistula rate (PPF)
The post-operative pancreatic fistula (PPF) rate will be measured using the definition of the International Study Group of Pancreatic Fistula (ISGPF) : any measurable amount of fluid from a drain placed during the operation or percutaneously, with an amylase concentration greater than three times the plasma value.
3 months
Secondary Outcomes (4)
Bleeding
3 months
Gastric Emptying Delay (GED)
3 months
Biliary Fistula
3 months
Other complications.
3 months
Study Arms (2)
Pancreatogastric anastomosis.
ACTIVE COMPARATORBlumgart Anastomosis
EXPERIMENTALInterventions
Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Blumgart anastomosis
Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Pancreatogastric anastomosis.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2020
First Posted
July 8, 2020
Study Start
June 4, 2020
Primary Completion
September 11, 2024
Study Completion
September 11, 2024
Last Updated
October 21, 2024
Record last verified: 2024-10