Margin Status After Pancreaticoduodenectomy for Cancer

Pancreatic Cancer Clinical Trial

Official title:

Margin Status After Pancreaticoduodenectomy for Cancer. Results of a Multicentric Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267966
• Other study ID #: NI 01/13
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: June 2019

Study information

• Verified date: February 2020
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This multicentric prospective randomized controlled trial (RCT) compares the Leeds Pathology Protocol (LEEPP) with other "conventional" pathological protocol of PD specimen for periampullary cancer. Our aims were to evaluate the impact of the protocol and of the clearance on R1 rate and its prognostic value.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: June 2019
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• pancreaticoduodenectomy for periampullary cancer

Exclusion Criteria:

• diagnosis of neuroendocrine neoplasm;

• previous pancreatic surgery;

• frozen section of each transection margins not performed or presence of positive transection margins without further resection (R1 intraoperative resection);

• presence of macroscopic residual tumor (R2 resection).

Related Conditions & MeSH terms

• Ampullary Cancer
• Cholangiocarcinoma
• Pancreatic Cancer

Intervention

Diagnostic Test:
• Leeds Pathology Protocol (LEEPP)
LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Campus Bio-Medico University	Azienda Ospedaliero, Universitaria Pisana, Humanitas Hospital, Italy, Medical University of Silesia

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	R1 resection rate	To evaluate difference in terms of R1 resection rates between study groups with 0-mm and 1-mm clearance	1 month
Secondary	pathological data	To evaluate differences in pathological results (T status, N status, number of blocks, number of lymphnodes, etc) between the two study groups	1 month
Secondary	oncological results	To evaluate the correlation between R1 resection and oncological results (local recurrence, overall survival) in the two study groups	60 months