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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


N/A
20 Years
N/A
Open (Enrolling)
Both
Gastric Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Time to drain removal

Outcome Description:

Daily amount of exudate is less than 100cc during consecutive 2 days. There is no evidence of anastomotic leakage, intra-abdominal abscess or bleeding.

Outcome Time Frame:

two weeks

Safety Issue:

No

Principal Investigator

WOO JIN HYUNG, M.D. Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Yonsei University Health System

Authority:

South Korea: Korea Food and Drug Administration (KFDA)

Study ID:

1-2012-0017

NCT ID:

NCT01742806

Start Date:

October 2012

Completion Date:

June 2013

Related Keywords:

  • Gastric Cancer
  • Gastric cancer
  • Minimally invasive surgery
  • Distal gastrectomy
  • Bio-absorbable Felt
  • Stomach Neoplasms

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