Learning Curve for Laparoscopic Distal Pancreatectomy

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01258621

First Posted: December 13, 2010

Last Update Posted: December 13, 2010

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Università Vita-Salute San Raffaele

Purpose

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.

Condition	Intervention
Pancreatic Lesions Located at Body or Tail.	Procedure: Laparoscopy


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Learning Curve for Laparoscopic Distal Pancreatectomy in a High-volume Hospital

Further study details as provided by Università Vita-Salute San Raffaele:

Primary Outcome Measures:

Conversion to open surgery [ Time Frame: during surgery; 3 to 5 hours from the start of the procedure ]

Secondary Outcome Measures:

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


Enrollment:	30
Study Start Date:	March 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Laparoscopic Distal Pancreatectomy	Procedure: Laparoscopy Laparoscopic distal pancreatectomy

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.

Eligibility

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Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

pancreatic lesion located at body or tail

Exclusion Criteria:

major vessels infiltration
severe organ dysfunction
refusing laparoscopic approach

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01258621

Locations


Italy
San Raffaele Hospital
Milan, Italy, 20132

Sponsors and Collaborators

Università Vita-Salute San Raffaele

More Information


Responsible Party:	Marco Braga, MD, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:	NCT01258621 History of Changes
Other Study ID Numbers:	PANCREAS-LDP2010
First Submitted:	December 10, 2010
First Posted:	December 13, 2010
Last Update Posted:	December 13, 2010
Last Verified:	August 2010

Keywords provided by Università Vita-Salute San Raffaele:


distal pancreatectomy, laparoscopy, learning curve

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