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Multicolour Versus Monocolour Specimens Inking After Pancreaticoduodenectomy for Periampullary Cancer

NCT02900950 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2016-09-15

No results posted yet for this study

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

Interventions

PROCEDURE

Multicolour inking specimens

PROCEDURE

Monocolour inking specimens

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Riccardo Casadei, Professor · S. Orsola-Malpighi Hospita, University of Bologna, Italy

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2016-01-31
Completion
2016-01-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02900950 on ClinicalTrials.gov