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Learning Curve for Laparoscopic Distal Pancreatectomy

Learning Curve for Laparoscopic Distal Pancreatectomy in a High-volume Hospital

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01258621
Enrollment
30
Registered
2010-12-13
Start date
2009-03-31
Completion date
2010-08-31
Last updated
2010-12-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Lesions Located at Body or Tail.

Keywords

distal pancreatectomy, laparoscopy, learning curve

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.

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.

Interventions

PROCEDURELaparoscopy

Laparoscopic distal pancreatectomy

Sponsors

Università Vita-Salute San Raffaele
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* pancreatic lesion located at body or tail

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Conversion to open surgeryduring surgery; 3 to 5 hours from the start of the procedure

Secondary

MeasureTime frame
Operative Timeduring surgery; 3 to 5 hours from the start of the procedure
Blood lossduring surgery; 3 to 5 hours from the start of the procedure
Length of Hospital StayPostoperative. From 0 to 30 days after discharge.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026