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

NCT ID: NCT01278368

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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).

Conditions

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Locally Advanced Pancreatic Adenocarcinoma

Keywords

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pancreatic cancer, neoadjuvant chemotherapy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Preoperative chemotherapy (PCHT)

Patients who underwent pancreatic resection after PCHT.

Group Type ACTIVE_COMPARATOR

Pancreatic resection after preoperative chemotherapy

Intervention Type PROCEDURE

Pancreatic resection after preoperative chemotherapy

Control

Patient who underwent pancreatic resection without preoperative therapy

Group Type ACTIVE_COMPARATOR

Pancreatic resection

Intervention Type PROCEDURE

Pancreatic resection

Interventions

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Pancreatic resection after preoperative chemotherapy

Pancreatic resection after preoperative chemotherapy

Intervention Type PROCEDURE

Pancreatic resection

Pancreatic resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of pancreatic cancer
* Preoperative chemotherapy
* Pancreatic resection

Exclusion Criteria

* Metastatic disease
* ASA score 4
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Marco Braga

Associate Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Braga, MD

Role: PRINCIPAL_INVESTIGATOR

Università Vita-Salute San Raffaele

Locations

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San Raffaele Hospital

Milan, Milan, Italy

Site Status

Countries

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Italy

Other Identifiers

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NEOADJUVANT_MATCH

Identifier Type: -

Identifier Source: org_study_id