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

National Taiwan University

Status: Unknown

Conditions: Esophageal Cancer

Treatments: Procedure: Minimally invasive esophagectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT03646110

201804074RINA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

single-incision MIE

Experimental group

Description:

Esophageal cancer patients received single-incision Minimally invasive esophagectomy

Treatment:

Procedure: Minimally invasive esophagectomy

multi-incision MIE

Active Comparator group

Description:

Esophageal cancer patients received multi-incision Minimally invasive esophagectomy

Treatment:

Procedure: Minimally invasive esophagectomy