Gastric CancerPhase 1/2NCT01338948
Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients
A Phase 1/2 study testing preoperative 3D-CT reconstruction in people with Gastric Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
The purpose of this study is to assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Gastric Cancer
- What is being tested?
- preoperative 3D-CT reconstruction
- Type of treatment
- Surgery or procedure
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2009to Dec 2009
- Phase
- Phase 1/2
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are older than 20 years
- Histologically confirmed gastric adenocarcinoma
- Patients who want robotic gastric cancer surgery
- Preoperative clinical stage Stage I (T1N0, T1N1, T2N0) diagnosed with EGD, EUS \& CT scan
- No history of drug allergy
- creatinine < 1.5 X upper normal limit
- Informed consent
Who cannot join
- Previous history of upper abdominal surgery
- Patient refused the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Feasibility Study on Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients
The purpose of this study is to assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure.
Read the detailed description
To assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure.
Diagnosis of early stage gastric cancer -> CT scanning \& EUS for staging -> (Registration) -> Robotic surgery with image reconstruction -> Conversion rate, Tumor location \& vascular anatomy correlation.
- Conditions
- Gastric Cancer
- Being tested
- preoperative 3D-CT reconstruction
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative 3D-CT reconstructionProcedure or surgery
Robotic Surgery with CT reconstruction images using Tile-pro program.
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of conversion (to laparotomy or laparoscopy assisted)
Visualization of upper abdominal vessels (seven vascular structures encountered during gastrectomy)
Measured: within 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startAug 2009
- Primary completionOct 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338948
- Sponsor's protocol ID
- 4-2009-0291
- Status last verified
- Mar 2011
- First submitted
- 29 Mar 2011
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Matsuki M, Kanazawa S, Kanamoto T, Inada Y, Kani H, Tanikake M, Yoshikawa S, Narabayashi I, Tatsumi Y, Nishimura H, Lee SW, Nomura E, Okuda J, Tanigawa N. Virtual CT gastrectomy by three-dimensional imaging using multidetector-row CT for laparoscopic gastrectomy. Abdom Imaging. 2006 May-Jun;31(3):268-76. doi: 10.1007/s00261-005-0360-2. No abstract available.
PubMed 16705397Kim YM, Baek SE, Lim JS, Hyung WJ. Clinical application of image-enhanced minimally invasive robotic surgery for gastric cancer: a prospective observational study. J Gastrointest Surg. 2013 Feb;17(2):304-12. doi: 10.1007/s11605-012-2094-0. Epub 2012 Dec 1.
PubMed 23207683
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study on Image-guided Minimally Invasive Robotic Surgery Using Preoperative CT Scan for Gastric Cancer Patients
- ClinicalTrials.gov ID
- NCT01338948
- Acronym / sponsor ID
- 4-2009-0291
- Conditions
- Gastric Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 20 Apr 2011 (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.
The purpose of this study is to assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure.
Detailed description
To assess the feasibility of image-guided surgery in patients with early stage gastric cancer using Robotic Surgery with Tile-pro program. For the assessment of the feasibility, conversion to open or laparoscopic surgery due to disturbance of will indicate the failure.
Diagnosis of early stage gastric cancer -> CT scanning \& EUS for staging -> (Registration) -> Robotic surgery with image reconstruction -> Conversion rate, Tumor location \& vascular anatomy correlation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients who are older than 20 years
- Histologically confirmed gastric adenocarcinoma
- Patients who want robotic gastric cancer surgery
- Preoperative clinical stage Stage I (T1N0, T1N1, T2N0) diagnosed with EGD, EUS \& CT scan
- No history of drug allergy
Key exclusion criteria (2 listed)
- Previous history of upper abdominal surgery
- Patient refused the study
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 |
|---|---|---|
| preoperative 3D-CT reconstructionRobotic Surgery with CT reconstruction images using Tile-pro program. | Procedure or surgery | – |
Primary outcome
rate of conversion (to laparotomy or laparoscopy assisted)
Time frame: within 24 hours after operation
Visualization of upper abdominal vessels (seven vascular structures encountered during gastrectomy)
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 20 Apr 2011.
- Background: PubMed 16705397Matsuki M, Kanazawa S, Kanamoto T, Inada Y, Kani H, Tanikake M, Yoshikawa S, Narabayashi I, Tatsumi Y, Nishimura H, Lee SW, Nomura E, Okuda J, Tanigawa N. Virtual CT gastrectomy by three-dimensional imaging using multidetector-row CT for laparoscopic gastrectomy. Abdom Imaging. 2006 May-Jun;31(3):268-76. doi: 10.1007/s00261-005-0360-2. No abstract available.
- Derived from this study: PubMed 23207683Kim YM, Baek SE, Lim JS, Hyung WJ. Clinical application of image-enhanced minimally invasive robotic surgery for gastric cancer: a prospective observational study. J Gastrointest Surg. 2013 Feb;17(2):304-12. doi: 10.1007/s11605-012-2094-0. Epub 2012 Dec 1.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing preoperative 3D-CT reconstruction in people with Gastric Cancer, run by Yonsei University at 1 site in South Korea.
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 7 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 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
rate of conversion (to laparotomy or laparoscopy assisted) (time frame: within 24 hours after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01338948, which also lists 2 linked publications.
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 20 Apr 2011.