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NCT Number: NCT01278368

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

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.

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Key information

Conditions

Locally Advanced Pancreatic Adenocarcinoma Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Hospital

Milan, 20132, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosis of pancreatic cancer
  • Preoperative chemotherapy
  • Pancreatic resection

Exclusion criteria

  • Metastatic disease
  • ASA score 4

Treatment and study plan

Pancreatic resection after preoperative chemotherapy

Procedure

Pancreatic resection after preoperative chemotherapy

Pancreatic resection

Procedure

Pancreatic resection

Primary outcomes

  1. Postoperative morbidity rate

    Time frame: Postoperative. From 0 to 30 days after discharge

Secondary outcomes

  1. Postoperative mortality

    Time frame: Postoperative. From 0 to 30 days after discharge

  2. Length of hospital stay (LOS)

    Time frame: Postoperative. From 0 to 30 days after discharge

Sponsors and collaborators

Lead sponsor

Università Vita-Salute San Raffaele

Other

Registry information

Official study title

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

Important dates

Study start
2003
Primary completion
2011
Study completion
2011
First posted
Jan 17, 2011
Registry last updated
Dec 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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