Multicolour Versus Monocolour Specimens Inking After Pancreaticoduodenectomy for Periampullary Cancer

NCT02900950 | Completed DMC

• 1 other identifier: MPM-DCP
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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

Stage, Pancreatic Cancer; Neoplasm, Residual; Pancreatic Neoplasm; Periampullary Cancer

Keywords

cancer; resection margin; pathology; pancreas

Outcome Measures

Primary Outcomes (2)

• Evaluate overall microscopic resection margins involvement (R1 rate) after pancreaticoduodenectomy for periampullary cancer.

  Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.

  At the time of pathological examination

• Evaluate R1 rate differences between multicolour and monocolour inking of the specimen

  Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.

  At the time of pathological examination

Secondary Outcomes (8)

• Evaluate R1 resection rate in anterior surface of the pancreatic head.

  At the time of pathological examination

• Evaluate R1 resection rate in posterior surface of the pancreatic head.

  At the time of pathological examination

• Evaluate R1 resection rate in superior mesenteric/portal vein groove

  At the time of pathological examination

• Evaluate R1 resection rate in superior mesenteric artery margin

  At the time of pathological examination

• Evaluate R1 resection rate in pancreatic transection margin

  At the time of pathological examination

Study Arms (2)

Arm A-Multicolour inking specimen

EXPERIMENTAL

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.

Procedure: Multicolour inking specimens

Arm B-Monocolour inking specimen

OTHER

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.

Procedure: Monocolour inking specimens

Interventions

Multicolour inking specimens PROCEDURE

Arm A-Multicolour inking specimen

Monocolour inking specimens PROCEDURE

Arm B-Monocolour inking specimen

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• medical history without previous pancreatic resection or pancreatic cancer
• written consent

You may not qualify if:

• 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).

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

S.Orsola-Malpighi Hospital, University of Bologna

Bologna, Bologna, 40138, Italy

Location

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm, Residual; Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Morphological and Microscopic Findings

Study Officials

• Riccardo Casadei, Professor

  S. Orsola-Malpighi Hospita, University of Bologna, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery at University of Bologna

Study Record Dates

• First Submitted: September 1, 2016
• First Posted: September 15, 2016
• Study Start: June 1, 2012
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: September 15, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)