Learning Curve for Laparoscopic Distal Pancreatectomy

Università Vita-Salute San Raffaele

Status: Completed

Conditions: Pancreatic Lesions Located at Body or Tail.

Treatments: Procedure: Laparoscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT01258621

PANCREAS-LDP2010

Details and patient eligibility

About

Laparoscopic distal pancreatectomy (LDP) for benign and borderline pancreatic lesions has recently becoming the treatment of choice in experienced centres. No data have been published about learning curve so far. The purpose of this study was to identify the learning curve period for performing LDP.

Full description

Between March 2009 and August 2010 all patients with lesion of body or tail of pancreas were assessed for eligibility for LDP. Exclusion criteria were: major vessels contact in cancer patients, severe organ dysfunction, BMI > 35, and refusing laparoscopic approach. All laparoscopic procedures were carried out by the same surgical team with large experience in open pancreatic surgery. All patients were treated according to an early recovery after surgery protocol. Primary endpoint was conversion rate. Secondary endpoints were operation time, operative blood loss, postoperative morbidity, and length of stay.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• pancreatic lesion located at body or tail

Exclusion criteria

• major vessels infiltration
• severe organ dysfunction
• refusing laparoscopic approach

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Laparoscopic Distal Pancreatectomy

Experimental group

Treatment:

Procedure: Laparoscopy