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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03646110
• Other study ID #: 201804074RINA
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2018
• Est. completion date: July 26, 2021

Study information

• Verified date: November 2020
• Source: National Taiwan University Hospital
• Contact: Jang-Ming Lee, MD PhD
• Phone: +886972651439
• Email: ntuhlee[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: July 26, 2021
• Est. primary completion date: July 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Surgical Wound

Intervention

Procedure:
• Minimally invasive esophagectomy
Minimally invasive esophagectomy is a surgical procedure for esophageal resection

Locations

Country	Name	City	State
Taiwan	Jang-Ming Lee	Taipei City	Zhongzheng Dist.

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival rate	Overall survival rate of the participants after surgery	60 months
Secondary	Pain score as assessed by the face rating scale	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
Secondary	Ratio of ambulation	30-minute walk test	post-operative day 2 (POD2)
Secondary	Postoperative force vital capacity	Force vital capacity (FVC) is one of the most common parameters for pulmonary function measured in spirometry	1 and 3 months
Secondary	Post operative forced expiratory volume in one second	Forced expiratory volume in one second (FEV1) is one of the most common parameters for pulmonary function measured in spirometry	1 and 3 months
Secondary	Postoperative pulmonary complication	pulmonary complication after esophagectomy	1 month

External Links

•   previous SIMIE study 1
•   previous SIMIE study 2