Benign Neoplasm of Body of PancreasPhase 4NCT02757690
Validation of 3 Dimensional Laparoscopic System in Disral Pancreatectomy and Splenectomy
A Phase 4 study testing 3-dimensional distal pancreatectomy and 2-dimensional distal pancreatectomy in people with Benign Neoplasm of Body of Pancreas and Benign Neoplasm of Tail of Pancreas, run by Asan Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Benign Neoplasm of Body of Pancreas, Benign Neoplasm of Tail of Pancreas
- What is being tested?
- 3-dimensional distal pancreatectomy and 2-dimensional distal pancreatectomy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Feb 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participants refusal.
- Additional resection dependent on pathological examination in intraoperative or postoperative period.
About this study
Official title: 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.
Read the detailed description
Procedures
- the investigators will take the patient consent for this clinical trial.
- The participants will be divided with two groups with block randomized method
- Skillful pancreatic surgeon will perform 2D or 3D laparoscopic distal pancreatectomy.
- The participants will be monitor the intraoperative and postoperative course.
Data collection
- operation video : operation time, number of errors (missed grasp, loss of material)
- Segmental operation time according to procedure
- Numbers of errors during operation
- clinical parameters:
- Blood examination : complete blood count (hemoglobin, white blood cell count), amylase, lipase, etc.
- Radiological examination: X-ray, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), etc
- Medical records : hospital stay after operation, the time to eating, pathologic examination
- Subjective scoring in the view of operator, 1st assist.
- Scoring for imaging quality
- Scoring for harms of 3D/2D laparoscopic system
- Scoring for overall demand
- Being tested
- 3-dimensional distal pancreatectomy, 2-dimensional distal pancreatectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-dimensional distal pancreatectomyDevice
Also called 3D
3D laparoscopy
2-dimensional distal pancreatectomyDevice
Also called 2D
2D laparoscopy
| Study group | Role | What they receive |
|---|---|---|
| 2-dimenasional distal pancreatectomy | Active comparator | device: 2 dimensional laparoscopy of Olympus Receives: Device: 2-dimensional distal pancreatectomy |
| 3-dimenasional distal pancreatectomy | Experimental | device : 3 dimensional laparoscopy of Olympus Receives: Device: 3-dimensional distal pancreatectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: expected duration: 200mins (for each operation)
Secondary outcomes (2)
Numbers of errors during operation
The investigators will check the error number of operator during operation with review the video record of the operation
Measured: 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.
Measured: During operation (expected duration: 200mins)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Neoplasm of Body of PancreasStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Principal investigator, Song Cheol Kim, Asan Medical Center
- Investigators
- Songcheol Kim, MD PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757690
- Sponsor's protocol ID
- 2D vs 3D LDPS comparison
- Status last verified
- Apr 2016
- First submitted
- 26 Apr 2016
- Last updated
- 2 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Verification of 3 Dimensional Laparoscopic System in Laparoscopic Distal Pancreatectomy & Splenectomy
- ClinicalTrials.gov ID
- NCT02757690
- Acronym / sponsor ID
- 2D vs 3D LDPS comparison
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Procedures
- the investigators will take the patient consent for this clinical trial.
- The participants will be divided with two groups with block randomized method
- Skillful pancreatic surgeon will perform 2D or 3D laparoscopic distal pancreatectomy.
- The participants will be monitor the intraoperative and postoperative course.
Data collection
- operation video : operation time, number of errors (missed grasp, loss of material)
- Segmental operation time according to procedure
- Numbers of errors during operation
- clinical parameters:
- Blood examination : complete blood count (hemoglobin, white blood cell count), amylase, lipase, etc.
- Radiological examination: X-ray, Computed Tomography (CT), Magnetic Resonance Imaging (MRI), etc
- Medical records : hospital stay after operation, the time to eating, pathologic examination
- Subjective scoring in the view of operator, 1st assist.
- Scoring for imaging quality
- Scoring for harms of 3D/2D laparoscopic system
- Scoring for overall demand
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2-dimenasional distal pancreatectomy | Active comparator | Device: 2-dimensional distal pancreatectomydevice: 2 dimensional laparoscopy of Olympus |
| 3-dimenasional distal pancreatectomy | Experimental | Device: 3-dimensional distal pancreatectomydevice : 3 dimensional laparoscopy of Olympus |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Participants refusal.
- Additional resection dependent on pathological examination in intraoperative or postoperative period.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3-dimensional distal pancreatectomyAlso: 3D3D laparoscopy | Device | 3-dimenasional distal pancreatectomy |
| 2-dimensional distal pancreatectomyAlso: 2D2D laparoscopy | Device | 2-dimenasional distal pancreatectomy |
Primary outcome
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.
2 secondary outcomes
Numbers of errors during operation
Time frame: During operation (expected duration: 200mins)
Subjective scoring in the view of operator, 1st assist
Time frame: During operation (expected duration: 200mins)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Songcheol Kim, MD PhD principal investigator
Asan Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 3-dimensional distal pancreatectomy and 2-dimensional distal pancreatectomy in people with Benign Neoplasm of Body of Pancreas and Benign Neoplasm of Tail of Pancreas, run by Asan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operation time (time frame: expected duration: 200mins (for each operation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2016.