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Learning Curve for Laparoscopic Distal Pancreatectomy

This study has been completed.
Sponsor:
Information provided by:
Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier:
NCT01258621
First received: December 10, 2010
Last updated: NA
Last verified: August 2010
History: No changes posted
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Learning Curve for Laparoscopic Distal Pancreatectomy in a High-volume Hospital

Resource links provided by NLM:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Operative Time [ Time Frame: during surgery; 3 to 5 hours from the start of the procedure ] [ Designated as safety issue: No ]
  • Blood loss [ Time Frame: during surgery; 3 to 5 hours from the start of the procedure ] [ Designated as safety issue: No ]
  • Length of Hospital Stay [ Time Frame: Postoperative. From 0 to 30 days after discharge. ] [ Designated as safety issue: No ]
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
Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01258621

Locations
Italy
San Raffaele Hospital
Milan, Italy, 20132
Sponsors and Collaborators
Università Vita-Salute San Raffaele
  More Information

No publications provided

Responsible Party: Marco Braga, MD, Università Vita-Salute San Raffaele
ClinicalTrials.gov Identifier: NCT01258621     History of Changes
Other Study ID Numbers: PANCREAS-LDP2010
Study First Received: December 10, 2010
Last Updated: December 10, 2010
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on March 01, 2015