Learning Curve for Laparoscopic Distal Pancreatectomy

Pancreatic Lesions Located at Body or Tail. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01258621
• Other study ID #: PANCREAS-LDP2010
• Status: Completed
• Phase: N/A
• First received: December 10, 2010
• Last updated: December 10, 2010
• Start date: March 2009
• Est. completion date: August 2010

Study information

• Verified date: August 2010
• Source: Università Vita-Salute San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• pancreatic lesion located at body or tail

Exclusion Criteria:

• major vessels infiltration

• severe organ dysfunction

• refusing laparoscopic approach

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatic Lesions Located at Body or Tail.

Intervention

Procedure:
• Laparoscopy
Laparoscopic distal pancreatectomy

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Università Vita-Salute San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion to open surgery		during surgery; 3 to 5 hours from the start of the procedure	No
Secondary	Operative Time		during surgery; 3 to 5 hours from the start of the procedure	No
Secondary	Blood loss		during surgery; 3 to 5 hours from the start of the procedure	No
Secondary	Length of Hospital Stay		Postoperative. From 0 to 30 days after discharge.	No