Pancreatic Neoplasm Clinical Trial
— MPMOfficial title:
Multicolour Versus Monocolour Inking Specimens After Pancreaticoduodenectomy for Periampullary Cancer: a Single Center Prospective Randomised Clinical Trial.
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.
Status | Completed |
Enrollment | 68 |
Est. completion date | January 2016 |
Est. primary completion date | January 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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). |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Italy | S.Orsola-Malpighi Hospital, University of Bologna | Bologna |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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. | At the time of pathological examination | No |
Secondary | 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. | At the time of pathological examination | No |
Secondary | 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. | At the time of pathological examination | No |
Secondary | 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. | At the time of pathological examination | No |
Secondary | 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. | At the time of pathological examination | No |
Secondary | 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. | At the time of pathological examination | No |
Secondary | Disease Free Survival and Overall Survival of the participants | Disease Free Survival and Overall Survival of the participants are measured using Kaplan-Meier curves. | Through study completion, an average of 6 months | No |
Secondary | 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). | Through study completion, an average of 6 months | No |
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