Validation of 3 Dimensional Laparoscopic System in Disral Pancreatectomy and Splenectomy

• ClinicalTrials.gov Identifier: NCT02757690
• Recruitment Status: Completed
• First Posted: May 2, 2016
• Last Update Posted: May 2, 2016
• Sponsor: Asan Medical Center
• Collaborator: Olympus
• Information provided by (Responsible Party): Song Cheol Kim, Asan Medical Center

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Benign Neoplasm of Body of Pancreas; Benign Neoplasm of Tail of Pancreas	Device: 3-dimensional distal pancreatectomy; Device: 2-dimensional distal pancreatectomy	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Official Title: Validation and Verification of 3 Dimensional Laparoscopic System in Laparoscopic Distal Pancreatectomy & Splenectomy
• Study Start Date: January 2015
• Actual Primary Completion Date: February 2016
• Actual Study Completion Date: February 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 2-dimenasional distal pancreatectomy; device: 2 dimensional laparoscopy of Olympus	Device: 2-dimensional distal pancreatectomy; 2D laparoscopy; Other Name: 2D
Experimental: 3-dimenasional distal pancreatectomy; device : 3 dimensional laparoscopy of Olympus	Device: 3-dimensional distal pancreatectomy; 3D laparoscopy; Other Name: 3D

Outcome Measures

Primary Outcome Measures :

1. Operation time [ Time Frame: expected duration: 200mins (for each operation) ]
   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.

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Sponsors and Collaborators

Asan Medical Center

Olympus

Investigators

• Principal Investigator: Songcheol Kim, MD PhD; Asan Medical Center

More Information

• Responsible Party: Song Cheol Kim, professor, Asan Medical Center
• ClinicalTrials.gov Identifier: NCT02757690
• Other Study ID Numbers: 2D vs 3D LDPS comparison
• First Posted: May 2, 2016
• Last Update Posted: May 2, 2016
• Last Verified: April 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

Additional relevant MeSH terms:

Brain Neoplasms; Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases