Minimally Invasive Versus open AbdominoThoracic Esophagectomy for esophageal carcinoma (MIVATE) - study protocol for a randomized controlled trial DRKS00016773

Abstract

Background: The only curative treatment for most esophageal cancers is radical esophagectomy. Minimally invasive esophagectomy (MIE) aims to reduce postoperative morbidity, but is not yet widely established. Linear stapled anastomosis is a promising technique for MIE because it is quite feasible even without robotic assistance. The aim of the present study is to compare total MIE with linear stapled anastomosis to open esophagectomy (OE) with circular stapled anastomosis with special regard to postoperative morbidity in an expertise-based randomized controlled trial (RCT).

Methods/design: This superiority RCT compares MIE with linear stapled anastomosis (intervention) to OE with circular stapled anastomosis (control) for Ivor-Lewis esophagectomy. It was initiated in February 2019, and recruitment is expected to last for 3 years. For inclusion, patients must be 18 years of age or more with a resectable primary malignancy in the distal esophagus. Participants with tumor localizations above the azygos vein, metastasis, or infiltration into adjacent tissue will be excluded. In an expertise-based approach, the allocated treatment will only be carried out by the single most experienced surgeon of the surgical center for each respective technique. The sample size was calculated with 20 participants per group for the primary endpoint postoperative morbidity according to comprehensive complication index (CCI) within 30 postoperative days. Secondary endpoints include anastomotic insufficiency, pulmonary complications, other intra- and postoperative outcome parameters such as estimated blood loss, operative time, length of stay, short-term oncologic endpoints, adherence to a standardized fast-track protocol, postoperative pain, and postoperative recovery (QoR-15). Quality of life (SF-36, CAT EORTC QLQ-C30, CAT EORTC QLQ-OES18) and oncological outcomes are evaluated with 60 months follow-up.

Discussion: MIVATE is the first RCT to compare OE with circular stapled anastomosis to total MIE with linear stapled anastomosis exclusively for intrathoracic anastomosis. The expertise-based approach limits bias due to heterogeneity of surgical expertise. The use of a dedicated fast-track protocol in both OE and MIE will shed light on the role of the access strategy alone in this setting. The findings of this study will serve to define which approach has the best perioperative outcome for patients requiring esophagectomy.

Trial registration: German Clinical Trials Register DRKS00016773 . Registered on 18 February 2019.

Keywords: Circular stapled anastomosis; Comprehensive complication index; Enhanced recovery after surgery; Esophageal cancer; Expertise-based; Fast track; Ivor-Lewis esophagectomy; Linear stapled anastomosis; Minimally invasive esophagectomy; Randomized controlled trial.

Fig. 1

Study design flow chart. CAT EORTC QLQ-C30, Computerized adaptive test European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30; CAT EORTC QLQ-OES18, Computerized adaptive test European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for Esophageal Cancer; CCI, Comprehensive Complication Index coding complications and related interventions according to the Dindo-Clavien classification; ICU, intermediate care unit; POD, postoperative day; POM, postoperative month; QoR-15, Quality of Recovery 15; SF-36, Short-Form 36. Only the most defining and relevant aspects of visit and follow-up documentation are indicated. For a more extensive list, please refer to Table 1 (trial visits)