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Impact of the Techniques for Intrathoracic Esophagogastric Anastomosis on Outcome in Ivor-Lewis Oesophagectomy

Randomized Study of Intrathoracic Side-to-side Stapled Esophagogastric Anastomosis Versus Circular-Stapled Technique in Ivor-Lewis Oesophagectomy

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01242124
Enrollment
40
Registered
2010-11-16
Start date
2011-01-31
Completion date
2016-12-31
Last updated
2015-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esophageal Cancer

Brief summary

The purpose of this study is to determine the safety and efficacy of the side-to-side stapled intrathoracic esophagogastric anastomosis in Ivor-Lewis Oesophagectomy.

Interventions

PROCEDUREside-to-side stapled esophagogastric anastomosis

20 patients of distal esophageal cancer receive side-to-side stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy

PROCEDUREcircular-stapled esophagogastric anastomosis

20 patients of distal esophageal cancer receive circular-stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy

Sponsors

Tianjin Medical University Cancer Institute and Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Cancer of the distal esophagus or gastroesophageal junction confirmed by biopsy (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) clinical stage I, II, or III. * Received no previous treatment for esophageal cancer * Adequate bone marrow, liver and kidney function * Patients must be able to understand the nature consent of the study and give written informed consent.

Exclusion criteria

* Age \< 18 years * History of significant heart disease * Inoperable on the basis of co-existent medical problems

Design outcomes

Primary

MeasureTime frameDescription
Long and short outcome related with anastomoses3 yearInclude anastomotic leakage,anastomotic stricture,regurgitation,heartburn, dumping syndrome and anastomoses diameter.

Secondary

MeasureTime frame
Quality of life and function outcomes3 year

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026