The Optimal Width of Gastric Conduit for Minimally Invasive Esophagectomy: Wide or Narrow?

Study Overview
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Brief Summary
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The study hypothesized that a narrow gastric conduit(less than 3cm in width) would minimize anastomotic leakage following minimally invasive esophagectomy. Therefore we raise this random-controlled research, and investigate the leakage ratio from different widths of gastric conduit formed during the operation.

Detailed Description
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Patients underwent minimally invasive esophagectomy in Zhongshan Hospital of Fudan University will be enrolled and be assigned to wide or narrow gastric conduit group randomly. Intra-operative blood supply and vascular SaO2 will be observed during the operation, and the rate of anastomotic leakage, together with its clinical details will be recorded in the two groups.

Official Title
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Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy

Conditions
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Anastomotic Leakage

Intervention / Treatment
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* Procedure: Narrowed Gastric Conduit
* Procedure: Widened Gastric Conduit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients underwent minimally invasive esophagectomy(three-hole procedure) Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy Exclusion Criteria: With previous cancer history Severe Co-morbidity
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Narrow Gastric Conduit<br>The group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy | Procedure: Narrowed Gastric Conduit<br>* The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy<br>* Other names: Narrowed Gastric Tube;|
| Experimental: Wide Gastric Conduit<br>The group in which widened gastric conduit will be performed during minimally invasive esophagectomy | Procedure: Widened Gastric Conduit<br>* A widened gastric tube will be formed during the surgery<br>* Other names: Wide Gastric Tube;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The anastomotic leakage rate | The anastomotic leakage is a severe complication following minimally invasive esophagectomy. The definition of anastomotic leakage is determined as per the STS (SOCIETY OF THORACIC SURGEONS) database. | the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minimally invasive esophagectomy, anastomotic leakage, gastric conduit