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Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

Information source: National Taiwan University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Anastomotic Leakage

Intervention: Mycostatin oral suspension (Drug); Water (Other)

Phase: Phase 2

Status: Recruiting

Sponsored by: National Taiwan University Hospital

Official(s) and/or principal investigator(s):
Pei-Ming Huang, MD, Principal Investigator, Affiliation: Department of Surgery, National Taiwan University Hospital

Overall contact:
Pei-Ming Huang, MD, Phone: +886-2-23123456, Ext: 63509, Email: e370089@gmail.com


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.

Clinical Details

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

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

Primary outcome: all cause anastomotic leakage

Secondary outcome: Time variation of starting oral feeding and hospital stay

Detailed 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.


Minimum age: 40 Years. Maximum age: 85 Years. Gender(s): Both.


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.

Locations and Contacts

Pei-Ming Huang, MD, Phone: +886-2-23123456, Ext: 63509, Email: e370089@gmail.com

National Taiwan University Hospital, Taipei 100, Taiwan; Recruiting
Pei-Ming Huang, MD, Phone: +886-2-23123456, Ext: 63509, Email: e370089@gmail.com
Pei-Ming Huang, MD, Principal Investigator
Additional Information

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

Related publications:

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

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.

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

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.

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.

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.

Starting date: June 2009
Last updated: July 20, 2009

Page last updated: August 23, 2015

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