Validation of 3 Dimensional Laparoscopic System in Disral Pancreatectomy and Splenectomy

Validation and Verification of 3 Dimensional Laparoscopic System in Laparoscopic Distal Pancreatectomy & Splenectomy

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.

Study Overview

• Status: Completed
• Conditions: Benign Neoplasm of Body of Pancreas; Benign Neoplasm of Tail of Pancreas
• Intervention / Treatment: Device: 2-dimensional distal pancreatectomy; Device: 3-dimensional distal pancreatectomy

Detailed Description

Procedures

1. the investigators will take the patient consent for this clinical trial.
2. The participants will be divided with two groups with block randomized method
3. Skillful pancreatic surgeon will perform 2D or 3D laparoscopic distal pancreatectomy.
4. The participants will be monitor the intraoperative and postoperative course.

Data collection

1. operation video : operation time, number of errors (missed grasp, loss of material)

   1. Segmental operation time according to procedure
   2. Numbers of errors during operation

2. clinical parameters:

   1. Blood examination : complete blood count (hemoglobin, white blood cell count), amylase, lipase, etc.
   2. Radiological examination: X-ray, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), etc
   3. Medical records : hospital stay after operation, the time to eating, pathologic examination

3. Subjective scoring in the view of operator, 1st assist.

   1. Scoring for imaging quality
   2. Scoring for harms of 3D/2D laparoscopic system
   3. Scoring for overall demand

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 2-dimenasional distal pancreatectomy; device: 2 dimensional laparoscopy of Olympus	Device: 2-dimensional distal pancreatectomy; 2D laparoscopy; Other Names: 2D
Experimental: 3-dimenasional distal pancreatectomy; device : 3 dimensional laparoscopy of Olympus	Device: 3-dimensional distal pancreatectomy; 3D laparoscopy; Other Names: 3D

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numbers of errors during operation	The investigators will check the error number of operator during operation with review the video record of the operation	During operation (expected duration: 200mins)
Subjective scoring in the view of operator, 1st assist	The investigators will check the subjective scoring of operator and 1st assist during operation. For example, depth perception, sharpness, visual strain, headache, etc.	During operation (expected duration: 200mins)

Collaborators and Investigators

• Sponsor: Asan Medical Center
• Collaborators: Olympus

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: April 26, 2016
• First Submitted That Met QC Criteria: April 29, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Estimate): May 2, 2016
• Last Update Submitted That Met QC Criteria: April 29, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms; Brain Neoplasms
• Other Study ID Numbers: 2D vs 3D LDPS comparison

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED