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2015-01
2016-02
2016-02
60
NCT02757690
Asan Medical Center
Asan Medical Center
INTERVENTIONAL
Validation of 3 Dimensional Laparoscopic System in Disral Pancreatectomy and 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.
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
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2016-04-26 | N/A | 2016-04-29 |
2016-04-29 | N/A | 2016-05-02 |
2016-05-02 | N/A | 2016-04 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
Randomized
Interventional Model:
Parallel
Masking:
Single
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
|
| EXPERIMENTAL: 3-dimenasional distal pancreatectomy device : 3 dimensional laparoscopy of Olympus | DEVICE: 3-dimensional distal pancreatectomy
|
| Primary Outcome Measures | 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 | 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) |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
21 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
NPCF was founded on May 29, 2009 and is a 501(c)(3) organization. All donations are tax deductible.
The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
