Validation of 3 Dimensional Laparoscopic System in Disral Pancreatectomy and Splenectomy

NCT02757690 | Completed Phase 4 DMC

• 1 other identifier: 2D vs 3D LDPS comparison
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Traditionally, laparoscopy has been based on 2-dimensional (2D) imaging, which has represented a considerable challenge for those approaching this technique. Thus, 3-dimensional (3D) visualization technology for laparoscopy has been proposed, since the early 1990s, as a way to facilitate laparoscopic performance. However, early 3D laparoscopic technology was limited in terms of image quality, so that its use had not been implemented. More recently, industry has developed novel 3D systems where the imaging is similar to stereoscopic vision, in which the depth perception is achieved by different unique images received by each eye. Thus, more recent studies have suggested a possible advantage provided by these new 3D systems during laparoscopic performance. However, comparative assessments of new generation 3D vs 2D laparoscopy remain limited, especially in the hepatobiliary and pancreatic field. To assess the benefits and harms of use of three dimensional systems versus two dimensional systems during laparoscopic distal pancreatectomy.

Conditions

Benign Neoplasm of Body of Pancreas; Benign Neoplasm of Tail of Pancreas

Outcome Measures

Primary Outcomes (1)

• Operation time

  The unedited videos of the operations will be assessed from start to end of the operation by two clinicians. The average of operation time will be compare according to 2D versus 3D laparoscopic system.

  expected duration: 200mins (for each operation)

Secondary Outcomes (2)

• Numbers of errors during operation

  During operation (expected duration: 200mins)

• Subjective scoring in the view of operator, 1st assist

  During operation (expected duration: 200mins)

Study Arms (2)

2-dimenasional distal pancreatectomy

ACTIVE COMPARATOR

device: 2 dimensional laparoscopy of Olympus

Device: 2-dimensional distal pancreatectomy

3-dimenasional distal pancreatectomy

EXPERIMENTAL

device : 3 dimensional laparoscopy of Olympus

Device: 3-dimensional distal pancreatectomy

Interventions

3-dimensional distal pancreatectomy DEVICE

3D laparoscopy

Also known as: 3D

3-dimenasional distal pancreatectomy

2-dimensional distal pancreatectomy DEVICE

2D laparoscopy

Also known as: 2D

2-dimenasional distal pancreatectomy

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI \> 30 (Kg/m2)
• History of severe or recurrent pancreatitis
• Mass size \> 10cm
• History of low abdomen major operation
• Additional resection for extra-pancreatic organ

You may not qualify if:

• Participants refusal.
• Additional resection dependent on pathological examination in intraoperative or postoperative period.

Sponsors & Collaborators

• Asan Medical Center: lead
• Olympus: collaborator

Study Officials

• Songcheol Kim, MD PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 26, 2016
• First Posted: May 2, 2016
• Study Start: January 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 2, 2016

Record last verified: 2016-04