Esophageal CancerMIOMIENCT03035071
Morbidity in Open Versus Minimally Invasive Esophagectomy
A study testing minimally invasive esophagectomy and open esophagectomy in people with Esophageal Cancer, run by Austrian Society Of Surgical Oncology.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Esophageal Cancer
- What is being tested?
- minimally invasive esophagectomy and open esophagectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2010to 18 Apr 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy
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.
Read the 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)
- Conditions
- Esophageal Cancer
- Being tested
- minimally invasive esophagectomy, open esophagectomy
- Keywords
- Minimal-invasive esophagectomy, Esophageal resection, Hybrid esophagectomy
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
minimally invasive esophagectomyProcedure or surgery
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 esophagectomyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| minimally invasive esophagectomy | Experimental | minimally invasive (laparoscopic) gastric mobilisation and gastric tube formation. Receives: Procedure: minimally invasive esophagectomy |
| open esophagectomy | Active comparator | open gastric mobilization and gastric tube formation Receives: Procedure: open esophagectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
morbidity
anastomotic leakage, gastric conduit necrosis and/or pneumonia
Measured: 30 days
mortality
Measured: 30 days
Secondary outcomes (4)
ICU stay
length of stay at the intensive care unit (ICU)
Measured: 90 days
hospital stay
length of stay at the hospital
Measured: 90 days
overall survival
long term overall survival
Measured: 5 years
relapse free survival
long term relapse free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2017 (estimated)
- Study start1 May 2010
- Primary completion19 Nov 2014
- Study completion18 Apr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austrian Society Of Surgical Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Paireder, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035071
- Sponsor's protocol ID
- AUT-MIOMIE-RCT
- Acronym
- MIOMIE
- Status last verified
- Jan 2017
- First submitted
- 25 Jan 2017
- Last updated
- 27 Jan 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 12049861Cunningham 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.
PubMed 16822992Low 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.
PubMed 17763917Schoppmann 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.
PubMed 20464423Schwameis 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.
PubMed 23645759Messager 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.
PubMed 26583671
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morbidity In Open Versus Minimally Invasive Hybrid Esophagectomy
- ClinicalTrials.gov ID
- NCT03035071
- Acronym / sponsor ID
- MIOMIE / AUT-MIOMIE-RCT
- Conditions
- Esophageal Cancer
- Keywords
- Minimal-invasive esophagectomy, Esophageal resection, Hybrid esophagectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Austrian Society Of Surgical OncologyUniversity, hospital or other
- Study start
- 1 May 2010 (actual)
- Primary completion
- 19 Nov 2014 (actual)
- Study completion
- 18 Apr 2016 (actual)
- First posted
- 27 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| minimally invasive esophagectomy | Experimental | Procedure: minimally invasive esophagectomyminimally invasive (laparoscopic) gastric mobilisation and gastric tube formation. |
| open esophagectomy | Active comparator | Procedure: open esophagectomyopen gastric mobilization and gastric tube formation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| minimally invasive esophagectomyIn 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. | Procedure or surgery | minimally invasive esophagectomy |
| open esophagectomyin 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. | Procedure or surgery | open esophagectomy |
Primary outcome
morbidity
Time frame: 30 days
anastomotic leakage, gastric conduit necrosis and/or pneumonia
mortality
Time frame: 30 days
4 secondary outcomes
ICU stay
Time frame: 90 days
hospital stay
Time frame: 90 days
overall survival
Time frame: 5 years
relapse free survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2017.
- Background: PubMed 12049861Medical 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.
- Background: PubMed 16822992Cunningham 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.
- Background: PubMed 17763917Low 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.
- Background: PubMed 20464423Schoppmann 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.
- Background: PubMed 23645759Schwameis 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.
- Background: PubMed 26583671Messager 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.
- Randomizer of the Medical University of ViennaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing minimally invasive esophagectomy and open esophagectomy in people with Esophageal Cancer, run by Austrian Society Of Surgical Oncology.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morbidity (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03035071, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2017.