Morbidity in Open Versus Minimally Invasive Esophagectomy

Esophageal Cancer Clinical Trial

— MIOMIE  

Official title:

Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03035071
• Other study ID #: AUT-MIOMIE-RCT
• Status: Completed
• Phase: N/A
• First received: January 25, 2017
• Last updated: January 26, 2017
• Start date: May 1, 2010
• Est. completion date: April 18, 2016

Study information

• Verified date: January 2017
• Source: Austrian Society Of Surgical Oncology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: April 18, 2016
• Est. primary completion date: November 19, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Procedure:
• minimally invasive esophagectomy
In the MIE group the laparoscopic procedure was performed for gastric tube formation. The patient was placed in supine position with legs apart. The surgeon stands between the legs using a five-trocar technique. Laparoscopy will be followed by an anterolateral thoracotomy in the fourth intercostal space.
• open esophagectomy
in the open group the gastric mobilization and gastric tube formation will be perfumed with an open surgical approach. Laparotomy will be performed, followed by an anterolateral thoracotomy in the fourth intercostal space.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Austrian Society Of Surgical Oncology

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	morbidity	anastomotic leakage, gastric conduit necrosis and/or pneumonia	30 days
Primary	mortality		30 days
Secondary	ICU stay	length of stay at the intensive care unit (ICU)	90 days
Secondary	hospital stay	length of stay at the hospital	90 days
Secondary	overall survival	long term overall survival	5 years
Secondary	relapse free survival	long term relapse free survival	5 years

External Links

•   Randomizer of the Medical University of Vienna