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

Università Vita-Salute San Raffaele

Status: Completed

Conditions: Locally Advanced Pancreatic Adenocarcinoma

Treatments: Procedure: Pancreatic resection; Procedure: Pancreatic resection after preoperative chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01278368

NEOADJUVANT_MATCH

Details and patient eligibility

About

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.

Full 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).

Enrollment: 150 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of pancreatic cancer
• Preoperative chemotherapy
• Pancreatic resection

Exclusion criteria

• Metastatic disease
• ASA score 4

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Preoperative chemotherapy (PCHT)

Active Comparator group

Description:

Patients who underwent pancreatic resection after PCHT.

Treatment:

Procedure: Pancreatic resection after preoperative chemotherapy

Control

Active Comparator group

Description:

Patient who underwent pancreatic resection without preoperative therapy

Treatment:

Procedure: Pancreatic resection