Learning Curve for Laparoscopic Distal Pancreatectomy

Learning Curve for Laparoscopic Distal Pancreatectomy in a High-volume Hospital

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Lesions Located at Body or Tail.
• Intervention / Treatment: Procedure: Laparoscopy

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy, 20132
    • San Raffaele Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• pancreatic lesion located at body or tail

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopic Distal Pancreatectomy	Procedure: Laparoscopy; Laparoscopic distal pancreatectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Conversion to open surgery	during surgery; 3 to 5 hours from the start of the procedure

Secondary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Università Vita-Salute San Raffaele

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): August 1, 2010
• Study Completion (Actual): August 1, 2010

Study Registration Dates

• First Submitted: December 10, 2010
• First Submitted That Met QC Criteria: December 10, 2010
• First Posted (Estimate): December 13, 2010

Study Record Updates

• Last Update Posted (Estimate): December 13, 2010
• Last Update Submitted That Met QC Criteria: December 10, 2010
• Last Verified: August 1, 2010

More Information

Terms related to this study

• Keywords: distal pancreatectomy, laparoscopy, learning curve
• Other Study ID Numbers: PANCREAS-LDP2010