Clinical trial · Interventional
Multicolour Versus Monocolour Specimens Inking After Pancreaticoduodenectomy for Periampullary Cancer
Multicolour Versus Monocolour Inking Specimens After Pancreaticoduodenectomy for Periampullary Cancer: a Single Center Prospective Randomised Clinical Trial.
- 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 single-centre, randomised clinical trial of patients affected by periampullary cancer who underwent pancreaticoduodenectomies which included two different types of specimen margination: arm A (multicolour inking) and arm B (monocolour inking). The randomisation of the specimen was made after the resection, blinded for the surgeons involved in the operation. The primary endpoint was the overall R1 resection rate and its difference between the two arms. The secondary endpoints were the R1 resection rate in each margin and its difference between the two arms, and the impact of margin status on survival. A sample size of 18 patients was required.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasm, Residual | Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Neoplasm | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Periampullary Cancer | Periampullary Adenocarcinoma | ALIAS | 0.90 |
| Stage, Pancreatic Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monocolour inking specimens | Procedure | — | UNRESOLVED |
| Multicolour inking specimens | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A-Multicolour inking specimen
- description
- After performing the pancreaticoduodenectomies, the surgeon intraoperatively inked the surfaces/margins of the specimen with different colours. The surfaces/margins inked were the following: 1. Anterior surface of the pancreas (yellow); 2. Posterior surface of the pancreas (orange); 3. Superior mesenteric/portal vein groove (blu); 4. Superior mesenteric artery margin (retroperitoneal margin) (red); 5. Transection margin of the bile duct (green) The trans-section pancreatic and gastric margins were not inked.
- interventionNames
- Procedure: Multicolour inking specimens
- type
- OTHER
- label
- Arm B-Monocolour inking specimen
- description
- In arm B, only the superior mesenteric artery margin and the pancreatic margin were intraoperatively indicated by the surgeon in the specimen: a single stitch to identify the transection pancreatic margin and a continuous suture to identify the superior mesenteric artery margin. Monochromatic inking of the superior mesenteric artery margin was subsequently carried out by the pathologist.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * medical history without previous pancreatic resection or pancreatic cancer * written consent Exclusion Criteria: * patients previously treated with chemotherapy radiotherapy or chemoradiotherapy for pancreatic cancer * patients with diagnostic doubts of chronic pancreatitis, serous cystic tumours, intraductal papillary mucinous tumours or neuroendocrine tumours * patients unresectable at laparotomy * patients who had undergone other pancreatic resections (total or subtotal pancreatectomy).
References
Publications (0)
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