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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01696682
Recruitment Status : Unknown
Verified February 2013 by Tan, Lijie, Fudan University.
Recruitment status was:  Recruiting
First Posted : October 1, 2012
Last Update Posted : February 11, 2013
Information provided by (Responsible Party):
Tan, Lijie, 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.

Condition or disease Intervention/treatment Phase
Anastomotic Leakage Procedure: Narrowed Gastric Conduit Procedure: Widened Gastric Conduit Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Study on the Difference of Anastomotic Leakage Ratio Between Wide and Narrow Gastric Conduit During Minimally Invasive Esophagectomy
Study Start Date : September 2012
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]
    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.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01696682

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

Division of Thoracic Surgery, Zhongshan Hospital of Fudan University Recruiting
Shanghai, China, 200032
Contact: Yaxing Shen, MD    86-13661983366   
Sub-Investigator: Hao Wang, MD         
Sponsors and Collaborators
Fudan University
Study Director: Lijie Tan, MD Fudan University

Responsible Party: Tan, Lijie, Associate Professor of Surgery; Vice Chief, Division of Thoracic Surgery, Fudan University Identifier: NCT01696682     History of Changes
Other Study ID Numbers: ZSchest2012001
First Posted: October 1, 2012    Key Record Dates
Last Update Posted: February 11, 2013
Last Verified: February 2013

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

Additional relevant MeSH terms:
Anastomotic Leak
Postoperative Complications
Pathologic Processes