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

Primary Purpose

Thyroid Gland Carcinoma, Thyroid Cancer, Thoracic Duct Leak

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Neoveil (Polyglycolic Acid Mesh)
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Gland Carcinoma focused on measuring thyroid cancer, Neoveil, seroma, chyle leakage

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jin Wook Yi

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Neoveil

Arm Description

No use of Neoveil in the neck node dissection area

Use of Neoveil in the neck node dissection area

Outcomes

Primary Outcome Measures

Change of triglyceride(TG) level in drained fluid
Triglyceride level in the drained fluid, check time 9:00AM, unit : mg/dL

Secondary Outcome Measures

Drain amount
Drained fluid amount during 24 hours (Baseline 6:00 AM), unit : ml

Full Information

First Posted
March 20, 2018
Last Updated
April 25, 2018
Sponsor
Seoul National University Hospital
Collaborators
Green Cross Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT03510143
Brief Title
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

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
May 1, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Green Cross Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Gland Carcinoma, Thyroid Cancer, Thoracic Duct Leak
Keywords
thyroid cancer, Neoveil, seroma, chyle leakage

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Neoveil applied // Neoveil non-applied
Masking
Participant
Masking Description
Participants cannot know the Neoveil apply in their surgery
Allocation
Randomized
Enrollment
330 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
No use of Neoveil in the neck node dissection area
Arm Title
Neoveil
Arm Type
Experimental
Arm Description
Use of Neoveil in the neck node dissection area
Intervention Type
Device
Intervention Name(s)
Neoveil (Polyglycolic Acid Mesh)
Intervention Description
Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery.
Primary Outcome Measure Information:
Title
Change of triglyceride(TG) level in drained fluid
Description
Triglyceride level in the drained fluid, check time 9:00AM, unit : mg/dL
Time Frame
Change from drain TG level from postoperative 1st day to postoperative 2nd day
Secondary Outcome Measure Information:
Title
Drain amount
Description
Drained fluid amount during 24 hours (Baseline 6:00 AM), unit : ml
Time Frame
Postoperative 1st and 2nd days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin Wook Yi, MD, MS
Phone
+82-2-2072-3243
Email
gnsljw@gmail.com
Facility Information:
Facility Name
Jin Wook Yi
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27784046
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.
Results Reference
result
PubMed Identifier
25860987
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.
Results Reference
result
PubMed Identifier
26597705
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.
Results Reference
result

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

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