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

Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01742806
• Other study ID #: 1-2012-0017
• Status: Recruiting
• Phase: N/A
• First received: November 20, 2012
• Last updated: December 3, 2012
• Start date: October 2012
• Est. completion date: June 2013

Study information

• Verified date: December 2012
• Source: Yonsei University
• Contact: WOO JIN HYUNG, M.D. Ph.D.
• Phone: 82-2-2228-2129
• Email: wjhyung[@]yuhs.ac
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University College of Medicine, Bucheon Hospital	Bucheon
Korea, Republic of	Dong-A University College of Medicine	Busan
Korea, Republic of	Seoul National University College of Medicine, Bundang Hospital	Seongnam-si	Gyenggi-do
Korea, Republic of	Seoul National University College of Medicine, Seoul National University Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul
Korea, Republic of	Ajou University Medical Center	Suwon	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

Hayashibe A, Sakamoto K, Shinbo M, Makimoto S, Nakamoto T. New method for prevention of bile leakage after hepatic resection. J Surg Oncol. 2006 Jul 1;94(1):57-60. — View Citation

Nakamura T, Shimizu Y, Watanabe S, Hitomi S, Kitano M, Tamada J, Matsunobe S. New bioabsorbable pledgets and non-woven fabrics made from polyglycolide (PGA) for pulmonary surgery: clinical experience. Thorac Cardiovasc Surg. 1990 Apr;38(2):81-5. — View Citation

Ueda K, Tanaka T, Li TS, Tanaka N, Hamano K. Sutureless pneumostasis using bioabsorbable mesh and glue during major lung resection for cancer: who are the best candidates? J Thorac Cardiovasc Surg. 2010 Mar;139(3):600-5. doi: 10.1016/j.jtcvs.2009.06.021. Epub 2009 Aug 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to discharge after surgery and postoperative complication	Time to discharge after surgery and postoperative complication are recorded	up to 30days after randomization	No
Primary	Time to drain removal	Daily amount of exudate is less than 100cc during consecutive 2 days. There is no evidence of anastomotic leakage, intra-abdominal abscess or bleeding.	two weeks	No
Secondary	total amount of exudate drainage	Total amount of exudate after surgery is recorded.	two weeks	No