Learning Curve for Laparoscopic Distal Pancreatectomy

Not Applicable

Completed

• Conditions: Pancreatic Lesions Located at Body or Tail.
• Interventions: Procedure: Laparoscopy

• Registration Number: NCT01258621
• Lead Sponsor: Università Vita-Salute San Raffaele

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2009-03
• Status Verified: 2010-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Study First Submitted: 2010-12-10
• Study First Submitted QC: 2010-12-10
• Last Update Submitted: 2010-12-10
• Study First Posted: 2010-12-13
• Last Update Posted: 2010-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• pancreatic lesion located at body or tail

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Laparoscopic Distal Pancreatectomy	Laparoscopy	-

Primary Outcome Measures

Name	Time	Method
Conversion to open surgery	during surgery; 3 to 5 hours from the start of the procedure

Secondary Outcome Measures

Name	Time	Method
Operative Time	during surgery; 3 to 5 hours from the start of the procedure
Blood loss	during surgery; 3 to 5 hours from the start of the procedure
Length of Hospital Stay	Postoperative. From 0 to 30 days after discharge.

Trial Locations

Locations (1)

San Raffaele Hospital; 🇮🇹 Milan, Italy