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

• Sponsor: Università Vita-Salute San Raffaele (Other)
• Overall Status: Completed
• CT.gov ID: NCT01278368
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 107
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Locally Advanced Pancreatic Adenocarcinoma	Procedure: Pancreatic resection after preoperative chemotherapy; Procedure: Pancreatic resection	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: PREOPERATIVE CHEMOTHERAPY DOES NOT ADVERSELY AFFECT SHORT-TERM OUTCOME AFTER PANCREATIC RESECTION.
• Study Start Date: Jan 1, 2003
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Postoperative morbidity rate [Postoperative. From 0 to 30 days after discharge]

Secondary Outcome Measures

1. Postoperative mortality [Postoperative. From 0 to 30 days after discharge]

2. Length of hospital stay (LOS) [Postoperative. From 0 to 30 days after discharge]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of pancreatic cancer

• Preoperative chemotherapy

• Pancreatic resection

Exclusion Criteria:

• Metastatic disease

• ASA score 4

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Raffaele Hospital	Milan		Italy	20132

Sponsors and Collaborators

• Università Vita-Salute San Raffaele

Investigators

• Principal Investigator: Marco Braga, MD, Università Vita-Salute San Raffaele

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marco Braga, Associate Professor of Surgery, Università Vita-Salute San Raffaele
• ClinicalTrials.gov Identifier: NCT01278368
• Other Study ID Numbers: NEOADJUVANT_MATCH
• First Posted: Jan 17, 2011
• Last Update Posted: Dec 24, 2012
• Last Verified: Dec 1, 2012

• Keywords provided by Marco Braga, Associate Professor of Surgery, Università Vita-Salute San Raffaele: pancreatic cancer, neoadjuvant chemotherapy
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

No Results Posted as of Dec 24, 2012