Effect of Polyglycolic Acid Mesh (Neoveil) in Thyroid Cancer Surgery

Thyroid Cancer Clinical Trial

Official title:

Effect of Polyglycolic Acid Mesh (Neoveil) for Reducing Drain Amount and Chyle Leakage After Thyroid Cancer Surgery: A Prospective, Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03510143
• Other study ID #: 1802-087-923
• Status: Not yet recruiting
• Phase: N/A
• First received: March 20, 2018
• Last updated: April 25, 2018
• Start date: May 1, 2018
• Est. completion date: December 31, 2020

Study information

• Verified date: April 2018
• Source: Seoul National University Hospital
• Contact: Jin Wook Yi, MD, MS
• Phone: +82-2-2072-3243
• Email: gnsljw[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a randomized controlled study to investigate the effect of "Polyglycolic Acid Mesh Sheet (NeoveilTM)" on the thyroid cancer surgery.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: December 31, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Related Conditions & MeSH terms

• Thoracic Duct Leak
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Gland Carcinoma
• Thyroid Neoplasms

Intervention

Device:
• Neoveil (Polyglycolic Acid Mesh)
Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery.

Locations

Country	Name	City	State
Korea, Republic of	Jin Wook Yi	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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 Pancreatect — View Citation

Kobayashi 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 an — View Citation

Kuwata 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of triglyceride(TG) level in drained fluid	Triglyceride level in the drained fluid, check time 9:00AM, unit : mg/dL	Change from drain TG level from postoperative 1st day to postoperative 2nd day
Secondary	Drain amount	Drained fluid amount during 24 hours (Baseline 6:00 AM), unit : ml	Postoperative 1st and 2nd days