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Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection

Primary Purpose

Locally Advanced Pancreatic Adenocarcinoma

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Pancreatic resection after preoperative chemotherapy
Pancreatic resection
Sponsored by
Università Vita-Salute San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Locally Advanced Pancreatic Adenocarcinoma focused on measuring pancreatic cancer, neoadjuvant chemotherapy

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of pancreatic cancer
  • Preoperative chemotherapy
  • Pancreatic resection

Exclusion Criteria:

  • Metastatic disease
  • ASA score 4

Sites / Locations

  • San Raffaele Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Preoperative chemotherapy (PCHT)

Control

Arm Description

Patients who underwent pancreatic resection after PCHT.

Patient who underwent pancreatic resection without preoperative therapy

Outcomes

Primary Outcome Measures

Postoperative morbidity rate

Secondary Outcome Measures

Postoperative mortality
Length of hospital stay (LOS)

Full Information

First Posted
January 14, 2011
Last Updated
December 21, 2012
Sponsor
Università Vita-Salute San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT01278368
Brief Title
Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection
Official Title
PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Università Vita-Salute San Raffaele

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
No comparative trial investigating the effect of preoperative chemotherapy for locally advanced pancreatic cancer on short-term postoperative outcome has been published so far. The aim of the present study is to assess the potential impact of preoperative chemotherapy on short-term postoperative outcome after pancreatic resection in a case-matched series of cancer patients.
Detailed Description
Between 2003 and 2011, patients with locally advanced (stage III) pancreatic cancer who were treated with preoperative chemotherapy (PCHT) underwent surgical resection. Each patient was matched with the closest two patients with pancreatic cancer ( control group ) selected from our prospective electronic database who met the following match criteria: age (+/- 3 years), gender, ASA score, type of resection, pancreatic duct diameter (+/- 1 mm), and tumour size (+/- 5 mm).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Pancreatic Adenocarcinoma
Keywords
pancreatic cancer, neoadjuvant chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Preoperative chemotherapy (PCHT)
Arm Type
Active Comparator
Arm Description
Patients who underwent pancreatic resection after PCHT.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patient who underwent pancreatic resection without preoperative therapy
Intervention Type
Procedure
Intervention Name(s)
Pancreatic resection after preoperative chemotherapy
Intervention Description
Pancreatic resection after preoperative chemotherapy
Intervention Type
Procedure
Intervention Name(s)
Pancreatic resection
Intervention Description
Pancreatic resection
Primary Outcome Measure Information:
Title
Postoperative morbidity rate
Time Frame
Postoperative. From 0 to 30 days after discharge
Secondary Outcome Measure Information:
Title
Postoperative mortality
Time Frame
Postoperative. From 0 to 30 days after discharge
Title
Length of hospital stay (LOS)
Time Frame
Postoperative. From 0 to 30 days after discharge

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: Diagnosis of pancreatic cancer Preoperative chemotherapy Pancreatic resection Exclusion Criteria: Metastatic disease ASA score 4
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marco Braga, MD
Organizational Affiliation
Università Vita-Salute San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Raffaele Hospital
City
Milan
ZIP/Postal Code
20132
Country
Italy

12. IPD Sharing Statement

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Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection

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