Thyroid Gland CarcinomaNCT03510143
Effect of Polyglycolic Acid Mesh (Neoveil) in Thyroid Cancer Surgery
A study testing Neoveil (Polyglycolic Acid Mesh) in people with Thyroid Gland Carcinoma and Thyroid Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is a randomized controlled study to investigate the effect of "Polyglycolic Acid Mesh Sheet (NeoveilTM)" on the thyroid cancer surgery. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Thyroid Gland Carcinoma, Thyroid Cancer, Thoracic Duct Leak
- What is being tested?
- Neoveil (Polyglycolic Acid Mesh)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2018to 31 Dec 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who are between 20 and 70 years of age
- Patients who agreed to the study
- Patients undergoing thyroidectomy and cervical node dissection for thyroid cancer
- Patients without perithyroidal organ infiltration or distant metastasis
- Before the operation, bilateral vocal cord movement was normal
- Patients without significant abnormal findings in laboratory tests before surgery
Who cannot join
- Patients judged to be inadequate by the person in charge of clinical trial
- Aspirin, anti-platelet medication within 7 days of admission
- Uncontrolled hypertension, diabetes, chronic renal failure, coagulation disorders
- Cardiovascular disease (angina, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
- Drug abuse and alcohol abuse
- History of esophagus and airway diseases
Show all 10Show fewer
- Patients who participated in other clinical trials within 30 days
- Patients who had previous history of neck irradiation or neck surgery
- Patients with a history of allergy to drugs
- For women, pregnant and lactating patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Polyglycolic Acid Mesh (Neoveil) for Reducing Drain Amount and Chyle Leakage After Thyroid Cancer Surgery: A Prospective, Randomized Controlled Study
This study is a randomized controlled study to investigate the effect of "Polyglycolic Acid Mesh Sheet (NeoveilTM)" on the thyroid cancer surgery.
Read the detailed description
Thyroid cancer is a most common solid organ cancer in South Korea, according to 2014 statistics from Korea Central Cancer Registry.
The most important treatment of thyroid cancer is a surgery. Principle of thyroid cancer surgery is cancer-involved thyroid gland resection and central/lateral compartment of neck node dissection.
Part of surgical complications associated with neck lymph node dissection are seroma and chyle leakage. Incidence of seroma and chyle leakage have been reported as 4-5% and 1-7% in previous studies. Currently, there's no effective agents to prevent these complications.
"Polyglycolic Acid Mesh Sheet (NeoveilTM)" is a tissue strengthening repair agent which is prevent air or fluid leakage. It's effects were proven in various surgical field - prevent air leakage in lung surgery, reduce pancreatic fistula in pancreas surgery and so on. However, there's no result in thyroid cancer surgery.
This study will investigate the usability of NeoveilTM in thyroid cancer surgery and have the effect of preventing seroma and chyle leakage.
- Conditions
- Thyroid Gland Carcinoma, Thyroid Cancer, Thoracic Duct Leak
- Being tested
- Neoveil (Polyglycolic Acid Mesh)
- Keywords
- thyroid cancer, Neoveil, seroma, chyle leakage
- Medical subject headings
- Thyroid Neoplasms, Seroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neoveil (Polyglycolic Acid Mesh)Device
Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | No use of Neoveil in the neck node dissection area |
| Neoveil | Experimental | Use of Neoveil in the neck node dissection area Receives: Device: Neoveil (Polyglycolic Acid Mesh) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of triglyceride(TG) level in drained fluid
Triglyceride level in the drained fluid, check time 9:00AM, unit : mg/dL
Measured: Change from drain TG level from postoperative 1st day to postoperative 2nd day
Secondary outcomes (1)
Drain amount
Drained fluid amount during 24 hours (Baseline 6:00 AM), unit : ml
Measured: Postoperative 1st and 2nd days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2018
- Study start1 May 2018 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion31 Dec 2020 (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 Thyroid Gland CarcinomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Model description
- Neoveil applied // Neoveil non-applied
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Green Cross Corporation
- Responsible party
- Principal investigator, Jin Wook Yi, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03510143
- Sponsor's protocol ID
- 1802-087-923
- Status last verified
- Apr 2018
- First submitted
- 20 Mar 2018
- Last updated
- 27 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jang JY, Shin YC, Han Y, Park JS, Han HS, Hwang HK, Yoon DS, Kim JK, Yoon YS, Hwang DW, Kang CM, Lee WJ, Heo JS, Kang MJ, Chang YR, Chang J, Jung W, Kim SW. Effect of Polyglycolic Acid Mesh for Prevention of Pancreatic Fistula Following Distal Pancreatectomy: A Randomized Clinical Trial. JAMA Surg. 2017 Feb 1;152(2):150-155. doi: 10.1001/jamasurg.2016.3644.
PubMed 27784046Kuwata T, Shinohara S, Takenaka M, Oka S, Chikaishi Y, Hirai A, Kuroda K, So T, Tanaka F. The impact of covering the bulla with an absorbable polyglycolic acid (PGA) sheet during pneumothorax surgery. Gen Thorac Cardiovasc Surg. 2016 Sep;64(9):558-60. doi: 10.1007/s11748-015-0545-8. Epub 2015 Apr 10.
PubMed 25860987Kobayashi S, Takeda Y, Nakahira S, Tsujie M, Shimizu J, Miyamoto A, Eguchi H, Nagano H, Doki Y, Mori M. Fibrin Sealant with Polyglycolic Acid Felt vs Fibrinogen-Based Collagen Fleece at the Liver Cut Surface for Prevention of Postoperative Bile Leakage and Hemorrhage: A Prospective, Randomized, Controlled Study. J Am Coll Surg. 2016 Jan;222(1):59-64. doi: 10.1016/j.jamcollsurg.2015.10.006. Epub 2015 Oct 23.
PubMed 26597705
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Polyglycolic Acid Mesh (Neoveil) for Reducing Drain Amount and Chyle Leakage After Thyroid Cancer Surgery: A Prospective, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03510143
- Acronym / sponsor ID
- 1802-087-923
- Conditions
- Thyroid Gland Carcinoma, Thyroid Cancer, Thoracic Duct Leak
- Keywords
- thyroid cancer, Neoveil, seroma, chyle leakage
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Green Cross Corporation
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 27 Apr 2018 (actual)
- 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 a randomized controlled study to investigate the effect of "Polyglycolic Acid Mesh Sheet (NeoveilTM)" on the thyroid cancer surgery.
Detailed description
Thyroid cancer is a most common solid organ cancer in South Korea, according to 2014 statistics from Korea Central Cancer Registry.
The most important treatment of thyroid cancer is a surgery. Principle of thyroid cancer surgery is cancer-involved thyroid gland resection and central/lateral compartment of neck node dissection.
Part of surgical complications associated with neck lymph node dissection are seroma and chyle leakage. Incidence of seroma and chyle leakage have been reported as 4-5% and 1-7% in previous studies. Currently, there's no effective agents to prevent these complications.
"Polyglycolic Acid Mesh Sheet (NeoveilTM)" is a tissue strengthening repair agent which is prevent air or fluid leakage. It's effects were proven in various surgical field - prevent air leakage in lung surgery, reduce pancreatic fistula in pancreas surgery and so on. However, there's no result in thyroid cancer surgery.
This study will investigate the usability of NeoveilTM in thyroid cancer surgery and have the effect of preventing seroma and chyle leakage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Neoveil applied // Neoveil non-applied
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –No use of Neoveil in the neck node dissection area |
| Neoveil | Experimental | Device: Neoveil (Polyglycolic Acid Mesh)Use of Neoveil in the neck node dissection area |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients who are between 20 and 70 years of age
- Patients who agreed to the study
- Patients undergoing thyroidectomy and cervical node dissection for thyroid cancer
- Patients without perithyroidal organ infiltration or distant metastasis
- Before the operation, bilateral vocal cord movement was normal
Key exclusion criteria (10 listed)
- Patients judged to be inadequate by the person in charge of clinical trial
- Aspirin, anti-platelet medication within 7 days of admission
- Uncontrolled hypertension, diabetes, chronic renal failure, coagulation disorders
- Cardiovascular disease (angina, heart failure, myocardial infarction, history of coronary artery disease, stroke, transient ischemic attack)
- Drug abuse and alcohol abuse
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 |
|---|---|---|
| Neoveil (Polyglycolic Acid Mesh)Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery. | Device | Neoveil |
Primary outcome
Change of triglyceride(TG) level in drained fluid
Time frame: Change from drain TG level from postoperative 1st day to postoperative 2nd day
Triglyceride level in the drained fluid, check time 9:00AM, unit : mg/dL
1 secondary outcome
Drain amount
Time frame: Postoperative 1st and 2nd days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2018.
- Results publication: PubMed 27784046Jang JY, Shin YC, Han Y, Park JS, Han HS, Hwang HK, Yoon DS, Kim JK, Yoon YS, Hwang DW, Kang CM, Lee WJ, Heo JS, Kang MJ, Chang YR, Chang J, Jung W, Kim SW. Effect of Polyglycolic Acid Mesh for Prevention of Pancreatic Fistula Following Distal Pancreatectomy: A Randomized Clinical Trial. JAMA Surg. 2017 Feb 1;152(2):150-155. doi: 10.1001/jamasurg.2016.3644.
- Results publication: PubMed 25860987Kuwata T, Shinohara S, Takenaka M, Oka S, Chikaishi Y, Hirai A, Kuroda K, So T, Tanaka F. The impact of covering the bulla with an absorbable polyglycolic acid (PGA) sheet during pneumothorax surgery. Gen Thorac Cardiovasc Surg. 2016 Sep;64(9):558-60. doi: 10.1007/s11748-015-0545-8. Epub 2015 Apr 10.
- Results publication: PubMed 26597705Kobayashi S, Takeda Y, Nakahira S, Tsujie M, Shimizu J, Miyamoto A, Eguchi H, Nagano H, Doki Y, Mori M. Fibrin Sealant with Polyglycolic Acid Felt vs Fibrinogen-Based Collagen Fleece at the Liver Cut Surface for Prevention of Postoperative Bile Leakage and Hemorrhage: A Prospective, Randomized, Controlled Study. J Am Coll Surg. 2016 Jan;222(1):59-64. doi: 10.1016/j.jamcollsurg.2015.10.006. Epub 2015 Oct 23.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neoveil (Polyglycolic Acid Mesh) in people with Thyroid Gland Carcinoma and Thyroid Cancer, run by Seoul National University Hospital 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 6 inclusion and 10 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 27 Apr 2018. 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.
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 Jin Wook Yi, MD, MS (+82-2-2072-3243, gnsljw@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of triglyceride(TG) level in drained fluid (time frame: Change from drain TG level from postoperative 1st day to postoperative 2nd day). 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 NCT03510143, 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 27 Apr 2018.