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Multicolour Versus Monocolour Specimens Inking After Pancreaticoduodenectomy for Periampullary Cancer (MPM)

Primary Purpose

Stage, Pancreatic Cancer, Neoplasm, Residual, Pancreatic Neoplasm

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Multicolour inking specimens
Monocolour inking specimens
Sponsored by
IRCCS Azienda Ospedaliero-Universitaria di Bologna
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Stage, Pancreatic Cancer focused on measuring cancer, resection margin, pathology, pancreas

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • S.Orsola-Malpighi Hospital, University of Bologna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Arm A-Multicolour inking specimen

Arm B-Monocolour inking specimen

Arm 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: Anterior surface of the pancreas (yellow); Posterior surface of the pancreas (orange); Superior mesenteric/portal vein groove (blu); Superior mesenteric artery margin (retroperitoneal margin) (red); Transection margin of the bile duct (green) The trans-section pancreatic and gastric margins were not inked.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Evaluate R1 resection rate in anterior surface of the pancreatic head.
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Evaluate R1 resection rate in posterior surface of the pancreatic head.
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Evaluate R1 resection rate in superior mesenteric/portal vein groove
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Evaluate R1 resection rate in superior mesenteric artery margin
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Evaluate R1 resection rate in pancreatic transection margin
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Evaluate R1 resection rate in common bile duct margin
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Disease Free Survival and Overall Survival of the participants
Disease Free Survival and Overall Survival of the participants are measured using Kaplan-Meier curves.
Relation between Disease Free Survival and Overall Survival of the participants and R status
Disease Free Survival and Overall Survival of the participants are measured using Kaplan-Meier curves and divided in subgroups related to their margin status (R0 versus R1).

Full Information

First Posted
September 1, 2016
Last Updated
September 9, 2016
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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1. Study Identification

Unique Protocol Identification Number
NCT02900950
Brief Title
Multicolour Versus Monocolour Specimens Inking After Pancreaticoduodenectomy for Periampullary Cancer
Acronym
MPM
Official Title
Multicolour Versus Monocolour Inking Specimens After Pancreaticoduodenectomy for Periampullary Cancer: a Single Center Prospective Randomised Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
This study was a single-centre, prospective, controlled, open, parallel group, randomised clinical trial, conducted in the tertiary referral University Centre of S.Orsola-Malpighi Hospital, Bologna, Italy, from June 2012 to January 2016, which enrolled patients affected by periampullary cancer who underwent pancreaticoduodenectomy (PD). All patients with suspected periampullary cancer were enrolled in the study, but only patients who underwent pancreaticoduodenectomy were randomised and allocated to a multicolour inking specimen (arm A, experimental) or a monocolour inking (arm B, control) after specimen was taken out from the operative field. The analysis regarded only the specimens of the patients who underwent PD in which the final pathologic report showed a diagnosis of invasive periampullary cancer (pancreatic, ampullary and distal bile duct). After performing the pancreaticoduodenectomies, the surgeon intraoperatively inked the surfaces/margins of the specimen with different colours. In the multicolour arm, the surfaces/margins inked were the following: Anterior surface of the pancreas (yellow); Posterior surface of the pancreas (orange); Superior mesenteric/portal vein groove (blu); Superior mesenteric artery margin (retroperitoneal margin) (red); Transection margin of the bile duct (green).The trans-section pancreatic and gastric margins were not inked. In the monocolour arm, 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. In both arms of treatment, the macroscopic evaluation and slicing of the surgical specimen followed the Leeds Pathology Protocol (LEEPP), and seven margins, which included the anterior, posterior, superior mesenteric /portal vein groove, superior mesenteric artery, bile duct, pancreatic neck and stomach margins, were examined. The primary endpoint was to evaluate the overall R1 resection rate and its difference between multicolour (arm A) and monocolour (arm B) inking of the specimen. The secondary endpoints were to evaluate the R1 resection rate in each margin: anterior and posterior surfaces of the pancreatic head; superior mesenteric/portal vein groove; superior mesenteric artery margin; transection pancreatic and bile duct margins, and its difference between the two arms compared. Finally, the impact of the margin status on survival was considered for each margin and type of periampullary tumours. Calculation of the sample size was based on the literature assumption that the overall incidence rate expected of R1 ranged from 10 to 76% while it increased to 81-85% when a standardised pathological technique and margination with multicolour inking, as described in arm A, was performed. To detect a difference in R1 rate between these values with a 5% alpha-error and a 80% beta-error at a two-sided 0.05 significance level, a sample size of 18 patients was required for each group. In relation to the fact that the patients were often randomised without a preoperative biopsy, and that following current literature the 5-13% of the presumed malignancies were benign, it was decided to randomise 25 patients in order to avoid a sample size smaller than expected. The sample size calculation was carried out using PS Power and Sample Size Calculation software (Department of Biostatistics; Vanderbilt University; Nashville, TN, USA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage, Pancreatic Cancer, Neoplasm, Residual, Pancreatic Neoplasm, Periampullary Cancer
Keywords
cancer, resection margin, pathology, pancreas

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm A-Multicolour inking specimen
Arm Type
Experimental
Arm 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: Anterior surface of the pancreas (yellow); Posterior surface of the pancreas (orange); Superior mesenteric/portal vein groove (blu); Superior mesenteric artery margin (retroperitoneal margin) (red); Transection margin of the bile duct (green) The trans-section pancreatic and gastric margins were not inked.
Arm Title
Arm B-Monocolour inking specimen
Arm Type
Other
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Multicolour inking specimens
Intervention Type
Procedure
Intervention Name(s)
Monocolour inking specimens
Primary Outcome Measure Information:
Title
Evaluate overall microscopic resection margins involvement (R1 rate) after pancreaticoduodenectomy for periampullary cancer.
Description
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Time Frame
At the time of pathological examination
Title
Evaluate R1 rate differences between multicolour and monocolour inking of the specimen
Description
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Time Frame
At the time of pathological examination
Secondary Outcome Measure Information:
Title
Evaluate R1 resection rate in anterior surface of the pancreatic head.
Description
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Time Frame
At the time of pathological examination
Title
Evaluate R1 resection rate in posterior surface of the pancreatic head.
Description
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Time Frame
At the time of pathological examination
Title
Evaluate R1 resection rate in superior mesenteric/portal vein groove
Description
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Time Frame
At the time of pathological examination
Title
Evaluate R1 resection rate in superior mesenteric artery margin
Description
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Time Frame
At the time of pathological examination
Title
Evaluate R1 resection rate in pancreatic transection margin
Description
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Time Frame
At the time of pathological examination
Title
Evaluate R1 resection rate in common bile duct margin
Description
Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.
Time Frame
At the time of pathological examination
Title
Disease Free Survival and Overall Survival of the participants
Description
Disease Free Survival and Overall Survival of the participants are measured using Kaplan-Meier curves.
Time Frame
Through study completion, an average of 6 months
Title
Relation between Disease Free Survival and Overall Survival of the participants and R status
Description
Disease Free Survival and Overall Survival of the participants are measured using Kaplan-Meier curves and divided in subgroups related to their margin status (R0 versus R1).
Time Frame
Through study completion, an average of 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riccardo Casadei, Professor
Organizational Affiliation
S. Orsola-Malpighi Hospita, University of Bologna, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
S.Orsola-Malpighi Hospital, University of Bologna
City
Bologna
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

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Multicolour Versus Monocolour Specimens Inking After Pancreaticoduodenectomy for Periampullary Cancer

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