Oral Anti-Infective Agent for Esophageal Anastomotic Leakage | NCT00942526

Studies
Oral Anti-Infective Agent for Esophageal Anastomotic Leakage

NCT00942526

Sponsor

National Taiwan University Hospital

Status

Unknown status

Last Update Posted

Jul 21, 2009Estimated

Enrollment

120Estimated

Phase

Phase 2

Conditions

Anastomotic Leakage

Interventions

Mycostatin oral suspension
Water

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Jul 20, 2009

First Submission Date that Met QC Criteria

Jul 20, 2009

First Posted Date

Jul 21, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 20, 2009

Last Update Posted Date

Jul 21, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

National Taiwan University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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:

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.
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention	no intervention with perioperative oral anti-infective agent or water for gargling
2	Sham Comparator	perioperative gargling with water	Other: Water
3	Experimental	perioperative oral gargling with oral anti-infective agent for seven days	Drug: Mycostatin oral suspension

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Mycostatin oral suspension	Drug	peroperative Mycostatin oral suspension ( 0.1MU/cc, 24cc/bt; 5cc qid)for 7 days	3

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
all cause anastomotic leakage		two years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Pei-Ming Huang, MD	Contact	+886-2-23123456	63509	e370089@gmail.com

Overall Officials

Name	Affiliation	Role
Pei-Ming Huang, MD	Department of Surgery, National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital	Recruiting	Taipei		100	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
6865459	Background	Liu K, Zhang GC, Cai ZJ. Avoiding anastomotic leakage following esophagogastrostomy. J Thorac Cardiovasc Surg. 1983 Jul;86(1):142-5.
11133560	Background	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.

ID	Term
D057868	Anastomotic Leak
D004938	Esophageal Neoplasms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D005770	Gastrointestinal Neoplasms

ID	Term
D006878	Hydroxides
D000468	Alkalies
D007287	Inorganic Chemicals
D000838	Anions
D007477