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

NCT ID: NCT03646110

Last Updated: 2020-11-05

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-17

Study Completion Date

2021-07-26

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single-incision MIE

Esophageal cancer patients received single-incision Minimally invasive esophagectomy

Group Type EXPERIMENTAL

Minimally invasive esophagectomy

Intervention Type PROCEDURE

Minimally invasive esophagectomy is a surgical procedure for esophageal resection

multi-incision MIE

Esophageal cancer patients received multi-incision Minimally invasive esophagectomy

Group Type ACTIVE_COMPARATOR

Minimally invasive esophagectomy

Intervention Type PROCEDURE

Minimally invasive esophagectomy is a surgical procedure for esophageal resection

Interventions

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Minimally invasive esophagectomy

Minimally invasive esophagectomy is a surgical procedure for esophageal resection

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jang-Ming Lee

Taipei, Zhongzheng Dist., Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Jang-Ming Lee, MD PhD

Role: CONTACT

[email protected]
+886972651439

Pei-Wen Yang, PhD

Role: CONTACT

[email protected]
+88623123456 ext. 65123

Facility Contacts

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Jang-Ming Lee, MD PhD

Role: primary

[email protected]
886-972651439

Pei-Wen Yang, PhD.

Role: backup

[email protected]
886-2-23123456 ext. 65123

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/26547093

previous SIMIE study 1

http://www.ncbi.nlm.nih.gov/pubmed/27826778

previous SIMIE study 2

Other Identifiers

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201804074RINA

Identifier Type: -

Identifier Source: org_study_id