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

Anastomotic Leakage Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01696682
• Other study ID #: ZSchest2012001
• Status: Recruiting
• Phase: N/A
• First received: September 22, 2012
• Last updated: February 7, 2013
• Start date: September 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2013
• Source: Fudan University
• Contact: Yaxing Shen, MD
• Phone: 86-13661983366
• Email: SHEN.YAXING[@]ZS-HOSPITAL.SH.CN
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leakage

Intervention

Procedure:
• Narrowed Gastric Conduit
The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy
• Widened Gastric Conduit
A widened gastric tube will be formed during the surgery

Locations

Country	Name	City	State
China	Division of Thoracic Surgery, Zhongshan Hospital of Fudan University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes