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

Not Applicable

• Conditions: Anastomotic Leakage
• Interventions: Procedure: Narrowed Gastric Conduit; Procedure: Widened Gastric Conduit

• Registration Number: NCT01696682
• Lead Sponsor: Fudan University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-09
• Study First Submitted: 2012-09-22
• Study First Submitted QC: 2012-09-28
• Study First Posted: 2012-10-01
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-07
• Last Update Posted: 2013-02-11
• Primary Completion: 2013-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients underwent minimally invasive esophagectomy(three-hole procedure)
2. Clinical Staged T1-3N0M0 esophageal cancer patients or: patients who were restaged as T1-3N0M0 esophageal cancer after neo-adjuvant therapy

Exclusion Criteria

1. With previous cancer history
2. Severe Co-morbidity

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Narrow Gastric Conduit	Narrowed Gastric Conduit	The group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy
Wide Gastric Conduit	Widened Gastric Conduit	The group in which widened gastric conduit will be performed during minimally invasive esophagectomy

Primary Outcome Measures

Name	Time	Method
The anastomotic leakage rate	the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks	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.

Trial Locations

Locations (1)

Division of Thoracic Surgery, Zhongshan Hospital of Fudan University; 🇨🇳 Shanghai, China