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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Tan, Lijie, Fudan University
ClinicalTrials.gov Identifier:
NCT01696682
First received: September 22, 2012
Last updated: February 7, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention
Anastomotic Leakage
Procedure: Narrowed Gastric Conduit
Procedure: Widened Gastric Conduit

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • The anastomotic leakage rate [ Time Frame: the anastomotic leakage of participants will be followed for the duration of hospital stay, an expected average of 2 weeks ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 200
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Narrow Gastric Conduit
The group in which narrowed gastric conduit will be performed during minimally invasive esophagectomy
Procedure: Narrowed Gastric Conduit
The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy
Other Name: Narrowed Gastric Tube
Experimental: Wide Gastric Conduit
The group in which widened gastric conduit will be performed during minimally invasive esophagectomy
Procedure: Widened Gastric Conduit
A widened gastric tube will be formed during the surgery
Other Name: Wide Gastric Tube

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01696682

Contacts
Contact: Yaxing Shen, MD 86-13661983366 SHEN.YAXING@ZS-HOSPITAL.SH.CN

Locations
China
Division of Thoracic Surgery, Zhongshan Hospital of Fudan University Recruiting
Shanghai, China, 200032
Contact: Yaxing Shen, MD    86-13661983366    shen.yaxing@zs-hospital.sh.cn   
Sub-Investigator: Hao Wang, MD         
Sponsors and Collaborators
Fudan University
Investigators
Study Director: Lijie Tan, MD Fudan University
  More Information

No publications provided

Responsible Party: Tan, Lijie, Associate Professor of Surgery; Vice Chief, Division of Thoracic Surgery, Fudan University
ClinicalTrials.gov Identifier: NCT01696682     History of Changes
Other Study ID Numbers: ZSchest2012001
Study First Received: September 22, 2012
Last Updated: February 7, 2013
Health Authority: China: Ethics Committee

Keywords provided by Fudan University:
minimally invasive esophagectomy
anastomotic leakage
gastric conduit

Additional relevant MeSH terms:
Anastomotic Leak
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on August 25, 2014