Clinical trial NCT03035071: Morbidity in Open Versus Minimally Invasive Esophagectomy
Official title: Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Esophageal Cancer
Keywords: Minimal-invasive esophagectomy
Esophageal resection
Hybrid esophagectomy
Lead sponsor: Austrian Society Of Surgical Oncology
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The MIOMIE trial is a prospective randomized controlled study comparing open and laparoscopic gastric tube formation in Ivor Lewis esophagectomy. Aim of this trial was to compare the minimally invasive approach with the standard open procedure regarding morbidity and mortality.

Detailed description: Esophageal resection is still associated with considerable morbidity and mortality. Standardized preoperative efforts could increase the outcome of these patients. While early reports of medical pioneers focused particularly on safety and feasibility, more recent studies showed that implementation of minimally invasive esophagectomy (MIE) was widely accepted. Since first reports of MIE, different techniques and adjustments have been discussed. A recent publication of a large prospective trial in Phase II showed the safety of a total minimally invasive approach (video assisted thoracoscopic surgery (VATS) and laparoscopy). Surgical technique however is still a subject of debate and the level of evidence remains still low. Proving feasibility does not warrant a paradigm shift, as experience is an important factor for safety and patient benefit.

The aim of this study was to evaluate morbidity and mortality of open esophagectomy (OE) versus hybrid-MIE in a randomized controlled setting.

Prior to surgery patients will be randomized either the minimally invasive surgery group (laparoscopic gastric tube formation and thoracotomy) or the the open surgery group (open gastric tube formation with an open laparotomy approach). Randomizing tool is the "randomizer" of the medical university of vienna. (link is attached below)

Eligibility criteria: Inclusion Criteria:

* adenocarcinoma of the esophagus and the esophagogastric junction in (Siewert) type I and II position
* esophageal squamous cell cancer
* patients, who require esophageal resection due to above mentioned diagnosis
* patients, who gave their informed consent

Exclusion Criteria:

* individuals who did not meet the inclusion criteria were excluded from the study.
* patients with tumor localization in the upper third of the esophagus and requiring cervical resection were excluded.
* patients, presenting other than AC or ESCC or showed contraindication for laparoscopy (history of large abdominal surgery or signs of hostile abdomen)
* patients with a history or presence of any other malignancy, except carcinoma in situ or basalioma

Primary outcomes:
measure: morbidity
timeFrame: 30 days
measure: mortality
timeFrame: 30 days
Secondary outcomes:
measure: ICU stay
timeFrame: 90 days
measure: hospital stay
timeFrame: 90 days
measure: overall survival
timeFrame: 5 years
measure: relapse free survival
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
References:
citation: Medical Research Council Oesophageal Cancer Working Group. Surgical resection with or without preoperative chemotherapy in oesophageal cancer: a randomised controlled trial. Lancet. 2002 May 18;359(9319):1727-33. doi: 10.1016/S0140-6736(02)08651-8.
citation: Cunningham D, Allum WH, Stenning SP, Thompson JN, Van de Velde CJ, Nicolson M, Scarffe JH, Lofts FJ, Falk SJ, Iveson TJ, Smith DB, Langley RE, Verma M, Weeden S, Chua YJ, MAGIC Trial Participants. Perioperative chemotherapy versus surgery alone for resectable gastroesophageal cancer. N Engl J Med. 2006 Jul 6;355(1):11-20. doi: 10.1056/NEJMoa055531.
citation: Low DE, Kunz S, Schembre D, Otero H, Malpass T, Hsi A, Song G, Hinke R, Kozarek RA. Esophagectomy--it's not just about mortality anymore: standardized perioperative clinical pathways improve outcomes in patients with esophageal cancer. J Gastrointest Surg. 2007 Nov;11(11):1395-402; discussion 1402. doi: 10.1007/s11605-007-0265-1. Epub 2007 Aug 31.
citation: Schoppmann SF, Prager G, Langer FB, Riegler FM, Kabon B, Fleischmann E, Zacherl J. Open versus minimally invasive esophagectomy: a single-center case controlled study. Surg Endosc. 2010 Dec;24(12):3044-53. doi: 10.1007/s00464-010-1083-1. Epub 2010 May 13.
citation: Schwameis K, Ba-Ssalamah A, Wrba F, Birner P, Prager G, Hejna M, Schmid R, Asari R, Zacherl J, Schoppmann SF. The implementation of minimally-invasive esophagectomy does not impact short-term outcome in a high-volume center. Anticancer Res. 2013 May;33(5):2085-91.
citation: Messager M, Pasquer A, Duhamel A, Caranhac G, Piessen G, Mariette C; FREGAT working groupFRENCH. Laparoscopic Gastric Mobilization Reduces Postoperative Mortality After Esophageal Cancer Surgery: A French Nationwide Study. Ann Surg. 2015 Nov;262(5):817-22; discussion 822-3. doi: 10.1097/SLA.0000000000001470.