Text Size

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

This study is currently recruiting participants.
Verified December 2012 by Yonsei University
Sponsor:
Information provided by (Responsible Party):
Yonsei University
ClinicalTrials.gov Identifier:
NCT01742806
First received: November 20, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Gastric Cancer
 Device: bio-absorbable felt(NEOVEIL®)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • Time to drain removal [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    Daily amount of exudate is less than 100cc during consecutive 2 days. There is no evidence of anastomotic leakage, intra-abdominal abscess or bleeding.


Secondary Outcome Measures:
  • total amount of exudate drainage [ Time Frame: two weeks ] [ Designated as safety issue: No ]
    Total amount of exudate after surgery is recorded.


Other Outcome Measures:
  • Time to discharge after surgery and postoperative complication [ Time Frame: up to 30days after randomization ] [ Designated as safety issue: No ]
    Time to discharge after surgery and postoperative complication are recorded


Estimated Enrollment: 120
Study Start Date: October 2012
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control
not to use bio-absorbable felt(NEOVEIL®)
Experimental: NEOVEIL®
To use bio-absorbable felt
 Device: bio-absorbable 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)
Other Name: bio-absorbable polyglicolic acid felt,NEOVEIL®

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01742806

Contacts
Contact: WOO JIN HYUNG, M.D. Ph.D. 82-2-2228-2129 wjhyung@yuhs.ac

Locations
Korea, Republic of
Seoul National University College of Medicine, Bundang Hospital Recruiting
Seongnam-si, Gyenggi-do, Korea, Republic of
Contact: Hyung-Ho Kim, M.D., Ph.D.            
Principal Investigator: Hyung-Ho Kim, M.D., Ph.D.            
Ajou University Medical Center Recruiting
Suwon, Gyeonggi-do, Korea, Republic of
Contact: Sang-Uk Han, M.D., Ph.D.            
Principal Investigator: Sang-Uk Han, M.D., Ph.D.            
Soonchunhyang University College of Medicine, Bucheon Hospital Recruiting
Bucheon, Korea, Republic of
Contact: Gyu Seok Cho, M.D., Ph.D.            
Principal Investigator: Gyu Seok Cho, M.D., Ph.D.            
Dong-A University College of Medicine Recruiting
Busan, Korea, Republic of
Contact: Min-Chan Kim, M.D., Ph.D.            
Principal Investigator: Min-chan Kim, M.D., Ph.D.            
The Catholic University of Korea, Yeouido St. Mary's Hospital Recruiting
Seoul, Korea, Republic of
Contact: WOOK KIM, M.D. Ph.D.            
Principal Investigator: WOOK KIM, M.D., Ph.D.            
Seoul National University College of Medicine, Seoul National University Hospital Not yet recruiting
Seoul, Korea, Republic of
Contact: Hyuk-Joon Lee, M.D., Ph.D.            
Principal Investigator: Hyuk-Joon Lee, M.D.,Ph.D.            
Yonsei University Health System, Severance Hospital Recruiting
Seoul, Korea, Republic of
Contact: WOO JIN HYUNG, M.D., Ph.D.         wjhyung@yuhs.ac    
Principal Investigator: WOO JIN HYUNG, M.D., Ph.D.            
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: WOO JIN HYUNG, M.D. Ph.D. Yonsei University Health System
  More Information

Publications:

Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT01742806     History of Changes
Other Study ID Numbers: 1-2012-0017
Study First Received: November 20, 2012
Last Updated: December 3, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Yonsei University:
Gastric cancer
Minimally invasive surgery
Distal gastrectomy
Bio-absorbable Felt

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
 Stomach Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013