Clinical trial · Interventional
Margin Status After Pancreaticoduodenectomy for Cancer
Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial
NCT03267966CI-TRIAL-00043223completedN/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)
This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other "conventional" pathological protocol of PD specimen for periampullary cancer. Our aims were to evaluate the impact of the protocol and of the clearance on R1 rate and its prognostic value.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ampullary Cancer | Ampulla of Vater Carcinoma | ALIAS | 0.90 |
| Cholangiocarcinoma | Cholangiocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leeds Pathology Protocol (LEEPP) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Leeds Pathology Protocol (LEEPP)
- interventionNames
- Diagnostic Test: Leeds Pathology Protocol (LEEPP)
- type
- NO_INTERVENTION
- label
- Group B
- description
- "Conventional" method of pathological evaluation
Primary outcomes (1)
- measure
- R1 resection rate
- timeFrame
- 1 month
- description
- To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance
Secondary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * pancreaticoduodenectomy for periampullary cancer Exclusion Criteria: * diagnosis of neuroendocrine neoplasm; * previous pancreatic surgery; * frozen section of each transection margins not performed or presence of positive transection margins without further resection (R1 intraoperative resection); * presence of macroscopic residual tumor (R2 resection).
References
Publications (0)
Data not yet available
No reference posted for this study.