NCT00942526

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2009

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 21, 2009

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 21, 2009

Status Verified

July 1, 2009

Enrollment Period

1.5 years

First QC Date

July 20, 2009

Last Update Submit

July 20, 2009

Conditions

Anastomotic Leakage

Keywords

esophageal canceranastomotic leakagePrevention of anastomotic leakage after esophageal surgery

Outcome Measures

Primary Outcomes (1)

  • all cause anastomotic leakage

    two years

Secondary Outcomes (1)

  • Time variation of starting oral feeding and hospital stay

    two years

Study Arms (3)

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

Mycostatin oral suspensionDRUG

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

3
WaterOTHER

perioperative gargling with water

2

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • carcinoma of the esophagus, operable stage I to III

You may not qualify if:

  • patients who were inoperable,
  • patients who had obvious impaired blood supply of gastric substitutes, and
  • patients who had non-cervical esophagogastrostomy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (6)

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

    PMID: 6865459BACKGROUND

  • 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.

    PMID: 11133560BACKGROUND

  • 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.

    PMID: 8091778BACKGROUND

  • 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.

    PMID: 3280882BACKGROUND

  • 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.

    PMID: 1575303BACKGROUND

  • 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.

    PMID: 1548890BACKGROUND

Related Links

MeSH Terms

Conditions

Anastomotic LeakEsophageal Neoplasms

Interventions

Water

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Pei-Ming Huang, MD

    Department of Surgery, National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pei-Ming Huang, MD

CONTACT

+886-2-23123456e370089@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 20, 2009

First Posted

July 21, 2009

Study Start

June 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

July 21, 2009

Record last verified: 2009-07

Locations

TW(1)