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

Not Applicable

Completed

• Conditions: Locally Advanced Pancreatic Adenocarcinoma
• Interventions: Procedure: Pancreatic resection after preoperative chemotherapy; Procedure: Pancreatic resection

• Registration Number: NCT01278368
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief 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.

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).

Study Timeline

• Study Start: 2003-01
• Study First Submitted: 2011-01-14
• Study First Submitted QC: 2011-01-14
• Study First Posted: 2011-01-17
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-21
• Last Update Posted: 2012-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• Diagnosis of pancreatic cancer
• Preoperative chemotherapy
• Pancreatic resection

Exclusion Criteria

• Metastatic disease
• ASA score 4

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Preoperative chemotherapy (PCHT)	Pancreatic resection after preoperative chemotherapy	Patients who underwent pancreatic resection after PCHT.
Control	Pancreatic resection	Patient who underwent pancreatic resection without preoperative therapy

Primary Outcome Measures

Name	Time	Method
Postoperative morbidity rate	Postoperative. From 0 to 30 days after discharge

Secondary Outcome Measures

Name	Time	Method
Postoperative mortality	Postoperative. From 0 to 30 days after discharge
Length of hospital stay (LOS)	Postoperative. From 0 to 30 days after discharge

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, Italy