Gastric CancerNCT01742806
Clinical Study for the Impact of Bio-absorbable Felt (NEOVEIL®) With Fibrin Sealant on Removal of Drainage Tube After Minimally Invasive Gastrectomy for Gastric Cancer
A study testing bio-absorbable felt(NEOVEIL®) in people with Gastric Cancer, run by Yonsei University at 7 sites in South Korea.
Trial summary
This study is to evaluate if Bio-absorbable Felt(NEOVEIL®) makes the amount of exudate reduce and shortens time until drain removal after minimally invasive surgery for early gastric cancer. 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?
- bio-absorbable felt(NEOVEIL®)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 7 sitesSouth Korea
- Study dates
- Oct 2012to Jun 2013
- Phase
- Interventional
- 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
- histologic confirmed gastric adenocarcinoma
- Patients who underwent laparoscopic distal gastrectomy.
- preoperative clinical stage I diagnosed with esophagogastroduodenoscopy,endoscopic ultrasonography and computerized tomography.
- patients who underwent more than D1+b lymphadenectomy
Who cannot join
- Vulnerable participants (pregnant women, under 20 year old, and so on)
- liver or renal disease (Ex. liver cirrhosis, end stage renal disease)
- Transfusion is needed preoperatively or postoperatively due to bleeding
- Preoperative or intraoperative evaluation confirm ascites.
- Patients who use anticoagulant preoperatively or postoperatively
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites, 7 recruiting
- Recruiting
Soonchunhyang University College of Medicine, Bucheon Hospital
Bucheon-si
Gyu Seok Cho, M.D., Ph.D.
Gyu Seok Cho, M.D., Ph.D.
- Recruiting
Dong-A University College of Medicine
Busan
Min-Chan Kim, M.D., Ph.D.
Min-chan Kim, M.D., Ph.D.
- Recruiting
Seoul National University College of Medicine, Bundang Hospital
Seongnam-si, Gyenggi-do
Hyung-Ho Kim, M.D., Ph.D.
Hyung-Ho Kim, M.D., Ph.D.
- Not yet recruiting
Seoul National University College of Medicine, Seoul National University Hospital
Seoul
Hyuk-Joon Lee, M.D., Ph.D.
Hyuk-Joon Lee, M.D.,Ph.D.
- Recruiting
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul
WOOK KIM, M.D. Ph.D.
WOOK KIM, M.D., Ph.D.
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul
WOO JIN HYUNG, M.D., Ph.D., wjhyung@yuhs.ac
WOO JIN HYUNG, M.D., Ph.D.
- Recruiting
Ajou University Medical Center
Suwon, Gyeonggi-do
Sang-Uk Han, M.D., Ph.D.
Sang-Uk Han, M.D., Ph.D.
About this study
Official title: Clinical Study for the Impact of Bio-absorbable Felt (NEOVEIL®) With Fibrin Sealant on Removal of Drainage Tube After Minimally Invasive Gastrectomy for Gastric Cancer: Multicenter Prospective Randomized Comparison Study
This study is to evaluate if Bio-absorbable Felt(NEOVEIL®) makes the amount of exudate reduce and shortens time until drain removal after minimally invasive surgery for early gastric cancer.
Read the detailed description
We investigate the effect on drainage amount of Bio-absorbable Felt(NEOVEIL®) after D1+b or D2 lymphadenectomy with distal gastrectomy for early gastric cancer.
This study is an randomised controlled trial undertaken in 7 centers in South Korea. Patients with stage I-II gastric cancer who is going to have curative distal gastrectomy with D1+b or D2 lymphadenectomy are randomly assigned to use bio-absorbable felt(NEOVEIL®) or not to use it. Block randomisation will be done by a central interactive computerised system, stratified by center.
- Conditions
- Gastric Cancer
- Being tested
- bio-absorbable felt(NEOVEIL®)
- Keywords
- Gastric cancer, Minimally invasive surgery, Distal gastrectomy, Bio-absorbable Felt
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bio-absorbable felt(NEOVEIL®)Device
Also called bio-absorbable polyglicolic acid felt,NEOVEIL®
To cover bio-absorbable felt over the lymphadenectomy area (hepatoduodenal ligament, #5 and 12/gastroduodenal artery, #6/ pancreas head /suprapancreatic area, #7,8 and 9)
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | not to use bio-absorbable felt(NEOVEIL®) |
| NEOVEIL® | Experimental | To use bio-absorbable felt Receives: Device: bio-absorbable felt(NEOVEIL®) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to drain removal
Daily amount of exudate is less than 100cc during consecutive 2 days. There is no evidence of anastomotic leakage, intra-abdominal abscess or bleeding.
Measured: two weeks
Secondary outcomes (1)
total amount of exudate drainage
Total amount of exudate after surgery is recorded.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2012 (estimated)
- Study startOct 2012
- Primary completionApr 2013 (estimated)
- Study completionJun 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- WOO JIN HYUNG, M.D. Ph.D., Principal investigator, Yonsei University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01742806
- Sponsor's protocol ID
- 1-2012-0017
- Status last verified
- Dec 2012
- First submitted
- 20 Nov 2012
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Nakamura T, Shimizu Y, Watanabe S, Hitomi S, Kitano M, Tamada J, Matsunobe S. New bioabsorbable pledgets and non-woven fabrics made from polyglycolide (PGA) for pulmonary surgery: clinical experience. Thorac Cardiovasc Surg. 1990 Apr;38(2):81-5. doi: 10.1055/s-2007-1013999.
PubMed 2161571Hayashibe A, Sakamoto K, Shinbo M, Makimoto S, Nakamoto T. New method for prevention of bile leakage after hepatic resection. J Surg Oncol. 2006 Jul 1;94(1):57-60. doi: 10.1002/jso.20548.
PubMed 16788945Ueda K, Tanaka T, Li TS, Tanaka N, Hamano K. Sutureless pneumostasis using bioabsorbable mesh and glue during major lung resection for cancer: who are the best candidates? J Thorac Cardiovasc Surg. 2010 Mar;139(3):600-5. doi: 10.1016/j.jtcvs.2009.06.021. Epub 2009 Aug 4.
PubMed 19656529
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study for the Impact of Bio-absorbable Felt (NEOVEIL®) With Fibrin Sealant on Removal of Drainage Tube After Minimally Invasive Gastrectomy for Gastric Cancer: Multicenter Prospective Randomized Comparison Study
- ClinicalTrials.gov ID
- NCT01742806
- Acronym / sponsor ID
- 1-2012-0017
- Conditions
- Gastric Cancer
- Keywords
- Gastric cancer, Minimally invasive surgery, Distal gastrectomy, Bio-absorbable Felt
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 5 Dec 2012 (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.
This study is to evaluate if Bio-absorbable Felt(NEOVEIL®) makes the amount of exudate reduce and shortens time until drain removal after minimally invasive surgery for early gastric cancer.
Detailed description
We investigate the effect on drainage amount of Bio-absorbable Felt(NEOVEIL®) after D1+b or D2 lymphadenectomy with distal gastrectomy for early gastric cancer.
This study is an randomised controlled trial undertaken in 7 centers in South Korea. Patients with stage I-II gastric cancer who is going to have curative distal gastrectomy with D1+b or D2 lymphadenectomy are randomly assigned to use bio-absorbable felt(NEOVEIL®) or not to use it. Block randomisation will be done by a central interactive computerised system, stratified by center.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –not to use bio-absorbable felt(NEOVEIL®) |
| NEOVEIL® | Experimental | Device: bio-absorbable felt(NEOVEIL®)To use bio-absorbable felt |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histologic confirmed gastric adenocarcinoma
- Patients who underwent laparoscopic distal gastrectomy.
- preoperative clinical stage I diagnosed with esophagogastroduodenoscopy,endoscopic ultrasonography and computerized tomography.
- patients who underwent more than D1+b lymphadenectomy
Key exclusion criteria (5 listed)
- Vulnerable participants (pregnant women, under 20 year old, and so on)
- liver or renal disease (Ex. liver cirrhosis, end stage renal disease)
- Transfusion is needed preoperatively or postoperatively due to bleeding
- Preoperative or intraoperative evaluation confirm ascites.
- Patients who use anticoagulant preoperatively or postoperatively
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 |
|---|---|---|
| bio-absorbable felt(NEOVEIL®)Also: bio-absorbable polyglicolic acid felt,NEOVEIL®To cover bio-absorbable felt over the lymphadenectomy area (hepatoduodenal ligament, #5 and 12/gastroduodenal artery, #6/ pancreas head /suprapancreatic area, #7,8 and 9) | Device | NEOVEIL® |
Primary outcome
Time to drain removal
Time frame: two weeks
Daily amount of exudate is less than 100cc during consecutive 2 days. There is no evidence of anastomotic leakage, intra-abdominal abscess or bleeding.
1 secondary outcome
total amount of exudate drainage
Time frame: two weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
- Background: PubMed 2161571Nakamura T, Shimizu Y, Watanabe S, Hitomi S, Kitano M, Tamada J, Matsunobe S. New bioabsorbable pledgets and non-woven fabrics made from polyglycolide (PGA) for pulmonary surgery: clinical experience. Thorac Cardiovasc Surg. 1990 Apr;38(2):81-5. doi: 10.1055/s-2007-1013999.
- Background: PubMed 16788945Hayashibe A, Sakamoto K, Shinbo M, Makimoto S, Nakamoto T. New method for prevention of bile leakage after hepatic resection. J Surg Oncol. 2006 Jul 1;94(1):57-60. doi: 10.1002/jso.20548.
- Background: PubMed 19656529Ueda K, Tanaka T, Li TS, Tanaka N, Hamano K. Sutureless pneumostasis using bioabsorbable mesh and glue during major lung resection for cancer: who are the best candidates? J Thorac Cardiovasc Surg. 2010 Mar;139(3):600-5. doi: 10.1016/j.jtcvs.2009.06.021. Epub 2009 Aug 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.
WOO JIN HYUNG, M.D. Ph.D. principal investigator
Yonsei University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing bio-absorbable felt(NEOVEIL®) in people with Gastric Cancer, run by Yonsei University at 7 sites 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 4 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 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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.
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 WOO JIN HYUNG, M.D. Ph.D. (82-2-2228-2129, wjhyung@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to drain removal (time frame: two weeks). 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 NCT01742806, which also lists 3 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 5 Dec 2012.