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

Not Applicable

• Conditions: Esophageal Cancer
• Interventions: Procedure: Minimally invasive esophagectomy

• Registration Number: NCT03646110
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

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

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 Timeline

• Study Start: 2018-08-17
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-22
• Study First Posted: 2018-08-24
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-03
• Last Update Posted: 2020-11-05
• Primary Completion: 2021-07-26
• Study Completion: 2021-07-26

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single-incision MIE	Minimally invasive esophagectomy	Esophageal cancer patients received single-incision Minimally invasive esophagectomy
multi-incision MIE	Minimally invasive esophagectomy	Esophageal cancer patients received multi-incision Minimally invasive esophagectomy

Primary Outcome Measures

Name	Time	Method
Overall survival rate	60 months	Overall survival rate of the participants after surgery

Secondary Outcome Measures

Name	Time	Method
Ratio of ambulation	post-operative day 2 (POD2)	30-minute walk test
Pain score as assessed by the face rating scale	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.
Postoperative force vital capacity	1 and 3 months	Force vital capacity (FVC) is one of the most common parameters for pulmonary function measured in spirometry
Post operative forced expiratory volume in one second	1 and 3 months	Forced expiratory volume in one second (FEV1) is one of the most common parameters for pulmonary function measured in spirometry
Postoperative pulmonary complication	1 month	pulmonary complication after esophagectomy

Trial Locations

Locations (1)

Jang-Ming Lee; 🇨🇳 Taipei City, Zhongzheng Dist., Taiwan