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Learning Curve for Laparoscopic Distal Pancreatectomy

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ClinicalTrials.gov Identifier: NCT01258621
Recruitment Status : Completed
First Posted : December 13, 2010
Last Update Posted : December 13, 2010
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Lesions Located at Body or Tail. Procedure: Laparoscopy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
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
Study Start Date : March 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010
Arms and Interventions
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Arm Intervention/treatment
Experimental: Laparoscopic Distal Pancreatectomy Procedure: Laparoscopy
Laparoscopic distal pancreatectomy


Outcome Measures
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Primary Outcome Measures :
  1. Conversion to open surgery [ Time Frame: during surgery; 3 to 5 hours from the start of the procedure ]

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

Eligibility Criteria
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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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: December 13, 2010    Key Record Dates
Last Update Posted: December 13, 2010
Last Verified: August 2010

Keywords provided by Università Vita-Salute San Raffaele:
distal pancreatectomy, laparoscopy, learning curve