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2003-01
2011-12
2011-12
150
NCT01278368
Università Vita-Salute San Raffaele
Università Vita-Salute San Raffaele
INTERVENTIONAL
Effect Of Preoperative Chemotherapy On 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.
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).
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 Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2011-01-14 | N/A | 2012-12-21 |
2011-01-14 | N/A | 2012-12-24 |
2011-01-17 | N/A | 2012-12 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Treatment
Allocation:
Non Randomized
Interventional Model:
Parallel
Masking:
None
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
|
| ACTIVE_COMPARATOR: Control Patient who underwent pancreatic resection without preoperative therapy | PROCEDURE: Pancreatic resection
|
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Postoperative morbidity rate | Postoperative. From 0 to 30 days after discharge |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Postoperative mortality | Postoperative. From 0 to 30 days after discharge | |
| Length of hospital stay (LOS) | Postoperative. From 0 to 30 days after discharge |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
