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

• Sponsor: National Taiwan University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03646110
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 35.3
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer	Procedure: Minimally invasive esophagectomy	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Comparison of Single and Multi-incision Minimally Invasive Esophagectomy for Treating Esophageal Cancer
• Actual Study Start Date: Aug 17, 2018
• Anticipated Primary Completion Date: Jul 26, 2021
• Anticipated Study Completion Date: Jul 26, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Overall survival rate [60 months]

   Overall survival rate of the participants after surgery

Secondary Outcome Measures

1. 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.

2. Ratio of ambulation [post-operative day 2 (POD2)]

   30-minute walk test

3. 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

4. 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

5. Postoperative pulmonary complication [1 month]

   pulmonary complication after esophagectomy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jang-Ming Lee	Taipei City	Zhongzheng Dist.	Taiwan	100

Sponsors and Collaborators

• National Taiwan University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• previous SIMIE study 1
• previous SIMIE study 2

Publications

None provided.

• Responsible Party: National Taiwan University Hospital
• ClinicalTrials.gov Identifier: NCT03646110
• Other Study ID Numbers: 201804074RINA
• First Posted: Aug 24, 2018
• Last Update Posted: Nov 5, 2020
• Last Verified: Nov 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by National Taiwan University Hospital: esophageal cancer; Minimally invasive esophagectomy (MIE); single-incision Minimally invasive esophagectomy (SIMIE)
• Additional relevant MeSH terms: Esophageal Neoplasms

Study Results

No Results Posted as of Nov 5, 2020