Clinical trial NCT03510143: Effect of Polyglycolic Acid Mesh (Neoveil) in Thyroid Cancer Surgery
Official title: Effect of Polyglycolic Acid Mesh (Neoveil) for Reducing Drain Amount and Chyle Leakage After Thyroid Cancer Surgery: A Prospective, Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Thyroid Gland Carcinoma
Thyroid Cancer
Thoracic Duct Leak
Keywords: thyroid cancer
Neoveil
seroma
chyle leakage
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Green Cross Corporation
First posted: 2018-04-27
Enrollment: 330
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Neoveil applied // Neoveil non-applied
Primary purpose: TREATMENT

Brief summary: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of triglyceride(TG) level in drained fluid
timeFrame: Change from drain TG level from postoperative 1st day to postoperative 2nd day
Secondary outcomes:
measure: Drain amount
timeFrame: Postoperative 1st and 2nd days
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jin Wook Yi
Study officials:
References:
citation: 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.
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: 10.1007/s11748-015-0545-8. Epub 2015 Apr 10.
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 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.