Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

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

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.

Study Overview

• Status: Unknown
• Conditions: Anastomotic Leakage
• Intervention / Treatment: Other: Water; Drug: Mycostatin oral suspension

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Pei-Ming Huang, MD; Phone Number: 63509 +886-2-23123456; Email: e370089@gmail.com

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 1; no intervention with perioperative oral anti-infective agent or water for gargling
Sham Comparator: 2; perioperative gargling with water	Other: Water; perioperative gargling with water
Experimental: 3; perioperative oral gargling with oral anti-infective agent for seven days	Drug: Mycostatin oral suspension; peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
all cause anastomotic leakage	two years

Secondary Outcome Measures

Outcome Measure	Time Frame
Time variation of starting oral feeding and hospital stay	two years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Principal Investigator: Pei-Ming Huang, MD, Department of Surgery, National Taiwan University Hospital

Publications and helpful links

General 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. doi: 10.2214/ajr.176.1.1760161.
• Bardini R, Asolati M, Ruol A, Bonavina L, Baseggio S, Peracchia A. Anastomosis. World J Surg. 1994 May-Jun;18(3):373-8. doi: 10.1007/BF00316817.
• 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. doi: 10.1016/0002-9610(92)90393-6.
• 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. doi: 10.1002/jso.2930490307.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): December 1, 2010
• Study Completion (Anticipated): December 1, 2010

Study Registration Dates

• First Submitted: July 20, 2009
• First Submitted That Met QC Criteria: July 20, 2009
• First Posted (Estimate): July 21, 2009

Study Record Updates

• Last Update Posted (Estimate): July 21, 2009
• Last Update Submitted That Met QC Criteria: July 20, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Keywords: esophageal cancer; anastomotic leakage; Prevention of anastomotic leakage after esophageal surgery
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Anastomotic Leak; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Anti-Bacterial Agents; Membrane Transport Modulators; Antifungal Agents; Ionophores; Nystatin
• Other Study ID Numbers: 200806035R