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Learning Curve for Laparoscopic Distal Pancreatectomy

NCT ID: NCT01258621

Last Updated: 2010-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pancreatic Lesions Located at Body or Tail.

Keywords

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distal pancreatectomy, laparoscopy, learning curve

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Laparoscopic Distal Pancreatectomy

Group Type EXPERIMENTAL

Laparoscopy

Intervention Type PROCEDURE

Laparoscopic distal pancreatectomy

Interventions

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Laparoscopy

Laparoscopic distal pancreatectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* pancreatic lesion located at body or tail

Exclusion Criteria

* major vessels infiltration
* severe organ dysfunction
* refusing laparoscopic approach
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Università Vita-Salute San Raffaele

OTHER

Sponsor Role lead

Responsible Party

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Università Vita-Salute San Raffaele

Locations

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San Raffaele Hospital

Milan, , Italy

Site Status

Countries

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Italy

Other Identifiers

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PANCREAS-LDP2010

Identifier Type: -

Identifier Source: org_study_id