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NCT01278368 Clinical Trial

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

Locally Advanced Pancreatic Adenocarcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01278368
Other study ID # NEOADJUVANT_MATCH
Secondary ID
Status Completed
Phase N/A
First received January 14, 2011
Last updated December 21, 2012
Start date January 2003
Est. completion date December 2011

Study information
Verified date December 2012
Source Università Vita-Salute San Raffaele
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility
Status Completed
Enrollment 150
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Diagnosis of pancreatic cancer

- Preoperative chemotherapy

- Pancreatic resection

Exclusion Criteria:

- Metastatic disease

- ASA score 4

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Pancreatic resection after preoperative chemotherapy
Pancreatic resection after preoperative chemotherapy
• Pancreatic resection
Pancreatic resection

Locations
Country Name City State
Italy San Raffaele Hospital Milan

Sponsors (1)
Lead Sponsor Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Postoperative morbidity rate Postoperative. From 0 to 30 days after discharge No
Secondary Postoperative mortality Postoperative. From 0 to 30 days after discharge No
Secondary Length of hospital stay (LOS) Postoperative. From 0 to 30 days after discharge No
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