NCT01258621

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 13, 2010

Completed
Last Updated

December 13, 2010

Status Verified

August 1, 2010

Enrollment Period

1.4 years

First QC Date

December 10, 2010

Last Update Submit

December 10, 2010

Conditions

Pancreatic Lesions Located at Body or Tail.

Keywords

distal pancreatectomy, laparoscopy, learning curve

Outcome Measures

Primary Outcomes (1)

  • Conversion to open surgery

    during surgery; 3 to 5 hours from the start of the procedure

Secondary Outcomes (3)

  • Operative Time

    during surgery; 3 to 5 hours from the start of the procedure

  • Blood loss

    during surgery; 3 to 5 hours from the start of the procedure

  • Length of Hospital Stay

    Postoperative. From 0 to 30 days after discharge.

Study Arms (1)

Laparoscopic Distal Pancreatectomy

EXPERIMENTAL
Procedure: Laparoscopy

Interventions

LaparoscopyPROCEDURE

Laparoscopic distal pancreatectomy

Laparoscopic Distal Pancreatectomy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • pancreatic lesion located at body or tail

You may not qualify if:

  • major vessels infiltration
  • severe organ dysfunction
  • refusing laparoscopic approach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

EndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 10, 2010

First Posted

December 13, 2010

Study Start

March 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

December 13, 2010

Record last verified: 2010-08

Locations

IT(1)