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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01278368
First Posted: January 17, 2011
Last Update Posted: December 24, 2012
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.
Information provided by (Responsible Party):
Marco Braga, Università Vita-Salute San Raffaele
  Purpose
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.

Condition Intervention
Locally Advanced Pancreatic Adenocarcinoma Procedure: Pancreatic resection after preoperative chemotherapy Procedure: Pancreatic resection

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION.

Further study details as provided by Marco Braga, Università Vita-Salute San Raffaele:

Primary Outcome Measures:
  • Postoperative morbidity rate [ Time Frame: Postoperative. From 0 to 30 days after discharge ]

Secondary Outcome Measures:
  • Postoperative mortality [ Time Frame: Postoperative. From 0 to 30 days after discharge ]
  • Length of hospital stay (LOS) [ Time Frame: Postoperative. From 0 to 30 days after discharge ]

Enrollment: 150
Study Start Date: January 2003
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of pancreatic cancer
  • Preoperative chemotherapy
  • Pancreatic resection

Exclusion Criteria:

  • Metastatic disease
  • ASA score 4
  Contacts and Locations
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): NCT01278368


Locations
Italy
San Raffaele Hospital
Milan, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
Investigators
Principal Investigator: Marco Braga, MD Università Vita-Salute San Raffaele
  More Information

Responsible Party: Marco Braga, Associate Professor of Surgery, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01278368     History of Changes
Other Study ID Numbers: NEOADJUVANT_MATCH
First Submitted: January 14, 2011
First Posted: January 17, 2011
Last Update Posted: December 24, 2012
Last Verified: December 2012

Keywords provided by Marco Braga, Università Vita-Salute San Raffaele:
pancreatic cancer, neoadjuvant chemotherapy

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms