The Comparison of Single and Multi-incision MIE for Esophageal Cancer

November 3, 2020 updated by: National Taiwan University Hospital

The Comparison of Single and Multi-incision Minimally Invasive Esophagectomy for Treating Esophageal Cancer

Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE).The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Surgery remains the main stay of treating esophageal cancer. However, esophagectomy is a complex and technical demanding surgical procedure harboring substantial morbidity and mortality. Minimally invasive esophagectomy (MIE) has been gradually adopted as a feasible and effective treatment option for esophageal cancer. The standardized procedure including lymph node dissection, esophageal mobilization and reconstruction can be effectively performed under minimized wound incision whereas rendering the patients a possibility of faster postoperative recovery and reduced risk of perioperative postoperative pulmonary complication. The procedure of MIE including the thoracoscopic and laparoscopic phases which are usually performed multiple incisional wounds. Previously the investigators have published the adoption of single-incision approach both in the thoracoscopic and laparoscopic phases in MIE (SIMIE). The preliminary clinical results showed that SIMIE can provide an equivalent perioperative outcome whereas reduced the wound pain on the days 7 after surgery as compared to MIE performed with multi-incision (MIMIE). The goal of the current study was to conduct a prospective randomized trial to compare the perioperative outcome and survival of SIMIE and MIMIE.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Zhongzheng Dist.
      • Taipei City, Zhongzheng Dist., Taiwan, 100
        • Recruiting
        • Jang-Ming Lee
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with a diagnosis of esophageal cancer
  2. Age between 35 to 75 years old
  3. Resectable tumor as evaluation by preoperative imaging studies.

Exclusion Criteria:

  1. Previous surgery in the chest or abdomen.
  2. Receiving definitive chemoradiation (5500 cGy or more).
  3. Tumor invasion to the trachea, spine or aorta.
  4. Liver cirrhosis with esophageal varices or liver cirrhosis refractory to medical treatment, Child C classification.
  5. Previous history of cerebral vascular attack.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: single-incision MIE
Esophageal cancer patients received single-incision Minimally invasive esophagectomy
Procedure: Minimally invasive esophagectomy
Minimally invasive esophagectomy is a surgical procedure for esophageal resection
Active Comparator: multi-incision MIE
Esophageal cancer patients received multi-incision Minimally invasive esophagectomy
Procedure: Minimally invasive esophagectomy
Minimally invasive esophagectomy is a surgical procedure for esophageal resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival rate
Time Frame: 60 months
Overall survival rate of the participants after surgery
60 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain score as assessed by the face rating scale
Time Frame: 1,7,14,28 days
The scale range of face rating scale is ranging from 0 (happy face) to 10 (crying face). Higher values represent a worse outcome.
1,7,14,28 days
Ratio of ambulation
Time Frame: post-operative day 2 (POD2)
30-minute walk test
post-operative day 2 (POD2)
Postoperative force vital capacity
Time Frame: 1 and 3 months
Force vital capacity (FVC) is one of the most common parameters for pulmonary function measured in spirometry
1 and 3 months
Post operative forced expiratory volume in one second
Time Frame: 1 and 3 months
Forced expiratory volume in one second (FEV1) is one of the most common parameters for pulmonary function measured in spirometry
1 and 3 months
Postoperative pulmonary complication
Time Frame: 1 month
pulmonary complication after esophagectomy
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 17, 2018

Primary Completion (Anticipated)

July 26, 2021

Study Completion (Anticipated)

July 26, 2021

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

August 22, 2018

First Posted (Actual)

August 24, 2018

Study Record Updates

Last Update Posted (Actual)

November 5, 2020

Last Update Submitted That Met QC Criteria

November 3, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201804074RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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