Clinical trial · Interventional
Pancreatic Anastomosis After Duodenopancreatectomy
Pancreatic Anastomosis After Duodenopancreatectomy: Pancreatogastrostomy Versus Blumgart Anastomosis: Prospective, Randomized and Multicentric Study
NCT04462354CI-TRIAL-00081787PANGASBLUMcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A national, multicenter, randomized, prospective, parallel group clinical study to evaluate two therapeutic strategies (invaginating pancreatogastric anastomosis versus Blumgart anastomosis).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Anastomotic Leak | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blumgart Anastomosis | Procedure | — | UNRESOLVED |
| Pancreatogastric anastomosis. | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Pancreatogastric anastomosis.
- interventionNames
- Procedure: Pancreatogastric anastomosis.
- type
- EXPERIMENTAL
- label
- Blumgart Anastomosis
- interventionNames
- Procedure: Blumgart Anastomosis
Primary outcomes (1)
- measure
- Postoperative pancreatic fistula rate (PPF)
- timeFrame
- 3 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.