Effect Of Preoperative Chemotherapy On Short-Term Outcome After Pancreatic Resection
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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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION. |
- Postoperative morbidity rate [ Time Frame: Postoperative. From 0 to 30 days after discharge ] [ Designated as safety issue: No ]
- Postoperative mortality [ Time Frame: Postoperative. From 0 to 30 days after discharge ] [ Designated as safety issue: No ]
- Length of hospital stay (LOS) [ Time Frame: Postoperative. From 0 to 30 days after discharge ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of pancreatic cancer
- Preoperative chemotherapy
- Pancreatic resection
Exclusion Criteria:
- Metastatic disease
- ASA score 4
Contacts and Locations More Information
No publications provided
| 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 |
| Study First Received: | January 14, 2011 |
| Last Updated: | December 21, 2012 |
| Health Authority: | Italy: Ministry of Health |
Keywords provided by Università Vita-Salute San Raffaele:
|
pancreatic cancer, neoadjuvant chemotherapy |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous |
ClinicalTrials.gov processed this record on May 16, 2013