Clinical trial · Interventional
Billroth II or Roux-en-Y Reconstruction for GJ After PD: Randomized Controlled Trial (PAUDA TRIAL)
Billroth II or Roux-en-Y Reconstruction for Gastrojejunostomy After Pancreaticoduodenectomy: Randomized Controlled Trial (PAUDA TRIAL): Comparison of Morbidity and Delayed Gastric Emptying
NCT02246205CI-TRIAL-00029918PAUDAcompletedN/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)
The aim of the study is to compare the effect of Roux-en Y reconstruction (study group, DPCDA) versus classical Child reconstruction (DPCUN) in the incidence of VGL in patients for DPC. The hypotesis of the study is that Roux-en Y reconstruction decreases incidence of DGE after pancreaticoduodenectomy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasm of Head of Pancreas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pancreaticoduodenectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- DPC DN
- description
- Roux-en Y reconstruction after pancreaticoduodenectomy
- interventionNames
- Procedure: Pancreaticoduodenectomy
- type
- ACTIVE_COMPARATOR
- label
- DPC UN
- description
- Child reconstruction after pancreaticoduodenectomy
- interventionNames
- Procedure: Pancreaticoduodenectomy
Primary outcomes (1)
- measure
- Delayed gastric emptying incidence after pancreaticoduodenectomy
- timeFrame
- within the first 60 daysafter surgery
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patients with pancreatic head cancer considered resectable after the extension study * Patients suffering from periampullary tumors considered resectable after the extension study * Patients suffering from pancreatic inflammatory disease with medically intractable pain * Patients who have read the information sheet of the study and signed the informed consent form Exclusion Criteria: * Patients with history of previous gastrectomy * Patients with associated resections of other organs, except for the superior portal vein or mesenteric vein * Patients with enlargement to total pancreatectomy * Patients who has recieved neoadjuvant treatment * Patients with plastic peritonitis * Patients with liver cirrhosis.
References
Publications (0)
Data not yet available
No reference posted for this study.