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

December 21, 2012 updated by: Marco Braga, Università Vita-Salute San Raffaele

PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Milan, Italy, 20132
        • San Raffaele Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of pancreatic cancer
  • Preoperative chemotherapy
  • Pancreatic resection

Exclusion Criteria:

  • Metastatic disease
  • ASA score 4

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Preoperative chemotherapy (PCHT)
Patients who underwent pancreatic resection after PCHT.
Procedure: Pancreatic resection after preoperative chemotherapy
Pancreatic resection after preoperative chemotherapy
Active Comparator: Control
Patient who underwent pancreatic resection without preoperative therapy
Procedure: Pancreatic resection
Pancreatic resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative morbidity rate
Time Frame: Postoperative. From 0 to 30 days after discharge
Postoperative. From 0 to 30 days after discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Postoperative mortality
Time Frame: Postoperative. From 0 to 30 days after discharge
Postoperative. From 0 to 30 days after discharge
Length of hospital stay (LOS)
Time Frame: Postoperative. From 0 to 30 days after discharge
Postoperative. From 0 to 30 days after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Università Vita-Salute San Raffaele

Investigators

  • Principal Investigator: Marco Braga, MD, Università Vita-Salute San Raffaele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

December 24, 2012

Last Update Submitted That Met QC Criteria

December 21, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEOADJUVANT_MATCH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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