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

NCT ID: NCT01696682

Last Updated: 2013-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Anastomotic Leakage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Narrow Gastric Conduit

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

Group Type EXPERIMENTAL

Narrowed Gastric Conduit

Intervention Type PROCEDURE

The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy

Wide Gastric Conduit

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

Group Type EXPERIMENTAL

Widened Gastric Conduit

Intervention Type PROCEDURE

A widened gastric tube will be formed during the surgery

Interventions

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Narrowed Gastric Conduit

The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy

Intervention Type PROCEDURE

Widened Gastric Conduit

A widened gastric tube will be formed during the surgery

Intervention Type PROCEDURE

Other Intervention Names

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Narrowed Gastric Tube Wide Gastric Tube

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Tan, Lijie

Associate Professor of Surgery; Vice Chief, Division of Thoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lijie Tan, MD

Role: STUDY_DIRECTOR

Fudan University

Locations

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Division of Thoracic Surgery, Zhongshan Hospital of Fudan University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yaxing Shen, MD

Role: CONTACT

86-13661983366

Facility Contacts

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Yaxing Shen, MD

Role: primary

86-13661983366

Other Identifiers

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ZSchest2012001

Identifier Type: -

Identifier Source: org_study_id

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