Stomach CancerPhase 3NCT01179750
The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
A Phase 3 study testing Ultrasonic Coagulating Shears in people with Stomach Cancer and Gastrectomy, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once during operation. It was proved that a laparoscopic gastric resection showed significantly shorter operative time and less work load distribution, and more stability of bleeding than before an introduction of ultrasonic… Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Stomach Cancer, Gastrectomy, Ultrasonic Coagulating Shears
- What is being tested?
- Ultrasonic Coagulating Shears
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2010to Jun 2011
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with the diagnosis of gastric cancer
- The patient who agrees to participate in this study by signing the informed consent form
Who cannot join
- The patient who refuse to participate in this study
- Have simultaneously other cancer
- Underwent cancer therapy at past time
- Have bleeding disorder, coagulation disorder, chronic disease (e.g.heart failure, cardiovascular disease, active hepatitis)
- Have a previous upper gastrointestinal surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 135-710
JaeMoon Bae, MD.,Ph.D., 82-2-3410-0252, jmoon.bae@samsung.com
SeungJong Oh, MD, 82-2-3410-1735, seungjong.oh@samsung.com
About this study
Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once during operation. It was proved that a laparoscopic gastric resection showed significantly shorter operative time and less work load distribution, and more stability of bleeding than before an introduction of ultrasonic coagulating shears .
In an open gastric cancer surgery, ultrasonic coagulating shears have been often used for lymph node dissection or cutting of small vessels in some hospitals in Korea. However its usefulness or effectiveness has not been fully proved. There was only one report about using ultrasonic coagulating shears in open gastrectomy. The report contained small number of subjects and surgical procedures were different from the investigators.
Read more
The investigators expect to reduce operative time and blood loss with ultrasonic coagulating shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and shorten the removal time of a drain, which will also shorten the hospital stay.
The objective of this study is to evaluate the safety and benefit of ultrasonic coagulating shears in open gastrectomy including usefulness and effectiveness by a randomized controlled, prospective study.
- Conditions
- Stomach Cancer, Gastrectomy, Ultrasonic Coagulating Shears
- Being tested
- Ultrasonic Coagulating Shears
- Keywords
- Ultrasonic coagulating shears in gastrectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Coagulating ShearsDevice
Also called Harmonic Ace
comparison of operated groups between with Ultrasonic Coagulating Shears and without them.
| Study group | Role | What they receive |
|---|---|---|
| No Ultrasonic Coagulating Shears group | No intervention | the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy; |
| ultrasonic coagulation shears group | Experimental | the other arm: operated group using ultrasonic coagulation shears during gastrectomy Receives: Device: Ultrasonic Coagulating Shears |
What is being measured
The primary outcome is the main question the study is designed to answer.
operation time
operation time: a time from the opening of peritoneal cavity to the retrieval of specimen
Measured: 2 weeks later after operation
amount of blood loss
amount of blood loss: an amount of blood loss during operation time
Measured: 2 weeks later after operation
Secondary outcomes (4)
C-reactive protein
Measured: post operative day #0, #1, #5
total lymphocyte count
Measured: post operative day #0, #1, #5
postoperative complications
Measured: 4 weeks later after operation
drainage from peritoneal cavity during hospital
amount of drainage: an amount of postoperative draining fluid from peritoneal cavity during hsopital
Measured: 2 weeks later after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2010 (estimated)
- Study startJan 2010
- Primary completionApr 2011 (estimated)
- Study completionJun 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- More trials run by Samsung 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- Jae Moon Bae, MD., Ph.D., Principal investigator, Samsung Medical Center, Sungkyunkwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01179750
- Sponsor's protocol ID
- 2009-08-089
- Status last verified
- Dec 2010
- First submitted
- 27 Jul 2010
- Last updated
- 16 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Tsimoyiannis EC, Jabarin M, Tsimoyiannis JC, Betzios JP, Tsilikatis C, Glantzounis G. Ultrasonically activated shears in extended lymphadenectomy for gastric cancer. World J Surg. 2002 Feb;26(2):158-61. doi: 10.1007/s00268-001-0199-9. Epub 2001 Dec 4.
PubMed 11865342
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Ultrasonic Coagulating Shears Compared to Monopolar Electrocautery in Open Gastric Cancer Surgery
- ClinicalTrials.gov ID
- NCT01179750
- Acronym / sponsor ID
- 2009-08-089
- Conditions
- Stomach Cancer, Gastrectomy, Ultrasonic Coagulating Shears
- Keywords
- Ultrasonic coagulating shears in gastrectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Jun 2011 (estimated)
- First posted
- 11 Aug 2010 (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.
Ultrasonic coagulating shears are made for performing for cutting and hemostasis at once during operation. It was proved that a laparoscopic gastric resection showed significantly shorter operative time and less work load distribution, and more stability of bleeding than before an introduction of ultrasonic coagulating shears .
In an open gastric cancer surgery, ultrasonic coagulating shears have been often used for lymph node dissection or cutting of small vessels in some hospitals in Korea. However its usefulness or effectiveness has not been fully proved. There was only one report about using ultrasonic coagulating shears in open gastrectomy. The report contained small number of subjects and surgical procedures were different from the investigators.
The investigators expect to reduce operative time and blood loss with ultrasonic coagulating shears. Ultrasonic coagulating shears will also enable us to dissect lymph node with closure of lymphatics. This may reduce the amount of drainage fluid from peritoneal cavity and shorten the removal time of a drain, which will also shorten the hospital stay.
The objective of this study is to evaluate the safety and benefit of ultrasonic coagulating shears in open gastrectomy including usefulness and effectiveness by a randomized controlled, prospective study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Ultrasonic Coagulating Shears group | No intervention | –the one arm: operated group without using Ultrasonic coagulation shears during gastrectomy; |
| ultrasonic coagulation shears group | Experimental | Device: Ultrasonic Coagulating Shearsthe other arm: operated group using ultrasonic coagulation shears during gastrectomy |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with the diagnosis of gastric cancer
- The patient who agrees to participate in this study by signing the informed consent form
Key exclusion criteria (5 listed)
- The patient who refuse to participate in this study
- Have simultaneously other cancer
- Underwent cancer therapy at past time
- Have bleeding disorder, coagulation disorder, chronic disease (e.g.heart failure, cardiovascular disease, active hepatitis)
- Have a previous upper gastrointestinal surgery
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 |
|---|---|---|
| Ultrasonic Coagulating ShearsAlso: Harmonic Acecomparison of operated groups between with Ultrasonic Coagulating Shears and without them. | Device | ultrasonic coagulation shears group |
Primary outcome
operation time
Time frame: 2 weeks later after operation
operation time: a time from the opening of peritoneal cavity to the retrieval of specimen
amount of blood loss
Time frame: 2 weeks later after operation
amount of blood loss: an amount of blood loss during operation time
4 secondary outcomes
C-reactive protein
Time frame: post operative day #0, #1, #5
total lymphocyte count
Time frame: post operative day #0, #1, #5
postoperative complications
Time frame: 4 weeks later after operation
drainage from peritoneal cavity during hospital
Time frame: 2 weeks later after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2010.
- Background: PubMed 11865342Tsimoyiannis EC, Jabarin M, Tsimoyiannis JC, Betzios JP, Tsilikatis C, Glantzounis G. Ultrasonically activated shears in extended lymphadenectomy for gastric cancer. World J Surg. 2002 Feb;26(2):158-61. doi: 10.1007/s00268-001-0199-9. Epub 2001 Dec 4.
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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.
Jae Moon Bae, MD., Ph.D. principal investigator
Samsung Medical Center, Sungkyunkwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ultrasonic Coagulating Shears in people with Stomach Cancer and Gastrectomy, run by Samsung Medical Center 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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Dec 2010. 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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jae Moon Bae, Professor (+82-2-3410-0252, jmoon.bae@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
operation time (time frame: 2 weeks later after operation). The study lists 2 primary outcomes in all. 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 NCT01179750, which also lists 1 linked publication.
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 16 Dec 2010.