Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02900950
Recruitment Status : Completed
First Posted : September 15, 2016
Last Update Posted : September 15, 2016
Sponsor:
Information provided by (Responsible Party):
Riccardo Casadei, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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.

Condition or disease Intervention/treatment Phase
Stage, Pancreatic Cancer Neoplasm, Residual Pancreatic Neoplasm Periampullary Cancer Procedure: Multicolour inking specimens Procedure: Monocolour inking specimens Not Applicable

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: Multicolour Versus Monocolour Inking Specimens After Pancreaticoduodenectomy for Periampullary Cancer: a Single Center Prospective Randomised Clinical Trial.
Study Start Date : June 2012
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Arm A-Multicolour inking specimen

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
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



Primary Outcome Measures :
  1. Evaluate overall microscopic resection margins involvement (R1 rate) after pancreaticoduodenectomy for periampullary cancer. [ Time Frame: At the time of pathological examination ]
    Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.

  2. Evaluate R1 rate differences between multicolour and monocolour inking of the specimen [ Time Frame: At the time of pathological examination ]
    Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.


Secondary Outcome Measures :
  1. Evaluate R1 resection rate in anterior surface of the pancreatic head. [ Time Frame: At the time of pathological examination ]
    Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.

  2. Evaluate R1 resection rate in posterior surface of the pancreatic head. [ Time Frame: At the time of pathological examination ]
    Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.

  3. Evaluate R1 resection rate in superior mesenteric/portal vein groove [ Time Frame: At the time of pathological examination ]
    Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.

  4. Evaluate R1 resection rate in superior mesenteric artery margin [ Time Frame: At the time of pathological examination ]
    Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.

  5. Evaluate R1 resection rate in pancreatic transection margin [ Time Frame: At the time of pathological examination ]
    Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.

  6. Evaluate R1 resection rate in common bile duct margin [ Time Frame: At the time of pathological examination ]
    Microscopic margin involvement (R1) was defined as a distance of the tumour from the resection margin of ≤1 mm.

  7. Disease Free Survival and Overall Survival of the participants [ Time Frame: Through study completion, an average of 6 months ]
    Disease Free Survival and Overall Survival of the participants are measured using Kaplan-Meier curves.

  8. Relation between Disease Free Survival and Overall Survival of the participants and R status [ Time Frame: Through study completion, an average of 6 months ]
    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).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02900950


Locations
Layout table for location information
Italy
S.Orsola-Malpighi Hospital, University of Bologna
Bologna, Italy, 40138
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
Investigators
Layout table for investigator information
Principal Investigator: Riccardo Casadei, Professor S. Orsola-Malpighi Hospita, University of Bologna, Italy

Layout table for additonal information
Responsible Party: Riccardo Casadei, Associate Professor of Surgery at University of Bologna, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT02900950    
Other Study ID Numbers: MPM-DCP
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: September 15, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Riccardo Casadei, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi:
cancer
resection margin
pathology
pancreas
Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatic Neoplasms
Neoplasm, Residual
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Neoplastic Processes
Pathologic Processes
Pancrelipase
Gastrointestinal Agents