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

Fudan University

Status: Unknown

Conditions: Anastomotic Leakage

Treatments: Procedure: Narrowed Gastric Conduit; Procedure: Widened Gastric Conduit

Study type: Interventional

Funder types: Other

Identifiers

NCT01696682

ZSchest2012001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Narrow Gastric Conduit

Experimental group

Description:

The group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy

Treatment:

Procedure: Narrowed Gastric Conduit

Wide Gastric Conduit

Experimental group

Description:

The group in which widened gastric conduit will be performed during minimally invasive esophagectomy

Treatment:

Procedure: Widened Gastric Conduit