Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

Anastomotic Leakage Clinical Trial

Official title:

The Correlation of Oral Anti-Infective Agent With Anastomotic Leakage in Reconstruction Surgery for Esophageal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00942526
• Other study ID #: 200806035R
• Status: Recruiting
• Phase: Phase 2
• First received: July 20, 2009
• Last updated: July 20, 2009
• Start date: June 2009
• Est. completion date: December 2010

Study information

• Verified date: July 2009
• Source: National Taiwan University Hospital
• Contact: Pei-Ming Huang, MD
• Phone: +886-2-23123456
• Email: e370089[@]gmail.com
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

Anastomotic leakage is still to be a major cause of considerable morbidity and mortality after esophagectomy and gastric pull up for esophageal carcinoma. Risk factor analyses of anastomotic leakage, including blood supply, graft tension, and comorbidity, have been performed, but few studies have produced strategies that have improved operative results. This study will be performed to identify prognostic variables that might be used to develop a strategy for optimizing outcomes after esophagogastrectomy.

Description:

Goal:

The effect of oral hygiene on the occurrence of esophagogastric anastomotic leakage has not yet been studied for along time. We will use a random cohort study model and investigate the effect of perioperative oral anti-infective gargle agent on the esophagogastric anastomotic wound healing.

Method:

1. Design:

One hundred and twenty patients are divided into 3 groups and each group has 40 esophageal patients. Minimization stratified randomization will be applied. Oral anti-infective gargling agent, Mycostatin oral suspension, will be employed for one week before operation. The first groups will be treated without oral gargle agent; the second groups will be treated with gargling water; and the third groups will be treated with anti-infective gargling agent.

An end-to-side two-layer esophagogastric anastomosis will be constructed using interrupted sutures with metallic staple through cervical wound. On the other hand, the anastomotic leakage rates in different groups will be investigated.

2. Data Collection and Statistic Analysis:

The records of all patients, various biologic parameters, and the management of leakage are analyzed. Thirty-day morbidity and mortality are determined, and stepwise multivariable logistic regression analysis assesses the effect of preoperative and postoperative variables on anastomotic leakage. Time variation of starting oral feeding and hospital stay are compared using the Kaplan-Meier method.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

Inclusion Criteria:

• carcinoma of the esophagus, operable stage I to III

Exclusion Criteria:

• patients who were inoperable,

• patients who had obvious impaired blood supply of gastric substitutes, and

• patients who had non-cervical esophagogastrostomy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leakage

Intervention

Drug:
• Mycostatin oral suspension
peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days

Other:
• Water
perioperative gargling with water

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (6)

Bardini R, Asolati M, Ruol A, Bonavina L, Baseggio S, Peracchia A. Anastomosis. World J Surg. 1994 May-Jun;18(3):373-8. Review. — View Citation

Dewar L, Gelfand G, Finley RJ, Evans K, Inculet R, Nelems B. Factors affecting cervical anastomotic leak and stricture formation following esophagogastrectomy and gastric tube interposition. Am J Surg. 1992 May;163(5):484-9. — View Citation

Liu K, Zhang GC, Cai ZJ. Avoiding anastomotic leakage following esophagogastrostomy. J Thorac Cardiovasc Surg. 1983 Jul;86(1):142-5. — View Citation

Patil PK, Patel SG, Mistry RC, Deshpande RK, Desai PB. Cancer of the esophagus: esophagogastric anastomotic leak--a retrospective study of predisposing factors. J Surg Oncol. 1992 Mar;49(3):163-7. — View Citation

Peracchia A, Bardini R, Ruol A, Asolati M, Scibetta D. Esophagovisceral anastomotic leak. A prospective statistical study of predisposing factors. J Thorac Cardiovasc Surg. 1988 Apr;95(4):685-91. — View Citation

Roy-Choudhury SH, Nicholson AA, Wedgwood KR, Mannion RA, Sedman PC, Royston CM, Breen DJ. Symptomatic malignant gastroesophageal anastomotic leak: management with covered metallic esophageal stents. AJR Am J Roentgenol. 2001 Jan;176(1):161-5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	all cause anastomotic leakage		two years	No
Secondary	Time variation of starting oral feeding and hospital stay		two years	No

External Links

•   National Taiwan University Hospital (NTUH) Research Ethics Committee (REC)