Clinical trial NCT03646110: The Comparison of Single and Multi-incision MIE for Esophageal Cancer
Official title: The Comparison of Single and Multi-incision Minimally Invasive Esophagectomy for Treating Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Esophageal Cancer
Keywords: esophageal cancer
Minimally invasive esophagectomy (MIE)
single-incision Minimally invasive esophagectomy (SIMIE)
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 100
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival rate
timeFrame: 60 months
Secondary outcomes:
measure: Pain score as assessed by the face rating scale
timeFrame: 1,7,14,28 days
measure: Ratio of ambulation
timeFrame: post-operative day 2 (POD2)
measure: Postoperative force vital capacity
timeFrame: 1 and 3 months
measure: Post operative forced expiratory volume in one second
timeFrame: 1 and 3 months
measure: Postoperative pulmonary complication
timeFrame: 1 month
Other outcomes:
Locations:
city: Taipei City
country: Taiwan
facility: Jang-Ming Lee
state: Zhongzheng Dist.
Study officials:
References: