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A multicenter randomized controlled trial to evaluate overall morbidity after total minimally invasive esophagectomy versus hybrid esophagectomy

Organizational Data

DRKS-ID:
DRKS00027927
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2022-07-04
Last update in DRKS:
2024-01-23
Registration type:
Prospective

Acronym/abbreviation of the study

MICkey

URL of the study

No Entry

Brief summary in lay language

Surgery on the esophagus is performed both in the abdominal cavity (abdomen) and in the chest (thorax). The minimally invasive approach (laparoscopic or robotic- assisted) is already established as the standard approach for the abdominal part of the operation. The chest part of the operation is frequently performed via open surgery (incision between the rips; thoracotomy). In specialized centers, however, this surgical step is now also carried out in a minimally invasive approach. In the MICkey trial, the abdominal part is performed minimally invasively in both treatment arms (=standard of care). The chest part of the operation will either be performed minimally invasive (treatment group A) or as open surgery (treatment group B). The study uses scientific methods to examine the differences between the two treatment groups. A total of 152 patients will take part in the study.

Brief summary in scientific language

Esophageal carcinoma is the sixth leading cause of cancer deaths worldwide and surgical removal of the esophagus is the only cure; frequently combined with other treatments like chemotherapy, immunotherapy or radiotherapy. However, up to 50% of patients experience complications as a result of the operation, which delays recovery, reduces quality of life, delays adjuvant treatment and increases costs. In the past the esophagus has been removed using a two-cavity surgical approach including open surgical access to the abdomen (laparotomy/abdominal incision) and to the chest (thoracotomy/incision on the chest). Today the combination of open access on the chest and minimally invasive access on the abdomen (laparoscopy/keyhole method) is the method of choice (HYBRID technique). So far there is no data showing whether the totally minimally invasive operation (surgery on the chest and abdomen using a minimally invasive approach = totally minimally invasive technique, MIN-E) leads to fewer complications than the combined operation (HYBRID). Methodologically high-quality, prospective studies for a direct comparison of the HYBRID technique with the total minimally invasive operation (MIN-E) are missing. The multicentre, randomized controlled MICkey study will compare the two surgical techniques (HYBRID versus MIN-E). The MICkey study will enroll 152 patients with esophageal cancer or cancer at the junction of the stomach and esophagus.

Health condition or problem studied

ICD10:
C15.9 - Oesophagus, unspecified
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Total minimally invasive esophagectomy (MIN-E; either via “classical” minimally invasive laparoscopy + thoracoscopy; or via robotic-assisted minimally invasive esophagectomy [RAMIE] or any combination of the two)
Arm 2:
Hybrid esophagectomy (HYBRID-E; laparoscopic/ robotic abdominal surgery and open thoracic surgery)

Endpoints

Primary outcome:
Overall postoperative morbidity in terms of the comprehensive complication index (CCI) within 30 days after surgery
Secondary outcome:
Procedure-specific morbidity measures: 1. 90-day mortality 2. Rate of re-operations within 90 days related to the index operation. 3. Pulmonary complications within 30 days postoperative according to Esophagectomy Complications Consensus Group (ECCG) definition 4. Esophagoenteric leak from anastomosis, staple line, or localized conduit necrosis within 30 days postoperative according to ECCG definition 5. Conduit necrosis/failure within 30 days postoperative according to ECCG definition 6. Delayed conduit emptying within 30 days postoperative according to ECCG definition 7. Chyle leak according to ECCG definition within 30 days 8. Recurrent nerve injury (vocal cord palsy) according to ECCG definition within 30 days Surgical outcomes measures: 1. Operative time (in minutes; from start of first skin incision until closure of last skin incision) 2. Length of hospital stay (in days; from the day of surgery until discharge) 3. Conversion rate to open surgery Patient-reported Outcome Measures (PROM): 4. Overall pain at rest and during movement (Numeric Rating Scale, NRS 0-10) 5. Assessment of postoperative thoracic pain syndrome measured as pain in the chest at rest and while coughing (NRS, 0-10) at visits 3-10 6. Quality of recovery according to QoR-15 7. Quality of life measured via QLQ-C30 and QLQ-OES18 at baseline Oncological outcome measures: 8. Total lymph node count 9. Rate of microscopic negative resection margin (R0) 10. Disease-free survival (defined as the time from randomization until disease recurrence (local recurrence or metastases) or death from any cause) within 2 years 11. Overall survival (defined as the time between randomization and death from any cause) within 2 years Safety measures: 12. Rate of serious adverse events defined as postoperative complications Clavien-Dindo grade III-V within 90 days.

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center Allgemein- und Viszeralchirurgie Ulm
  • University medical center Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Heidelberg

Recruitment period and number of participants

Planned study start date:
2023-01-31
Actual study start date:
2023-06-14
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
152
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional Inclusion Criteria:
1.) Malignant tumor of the thoracic esophagus or the esophagogastric junction considered to be resectable with curative intent via esophagectomy by means of an abdominal and right thoracic approach (Ivor-Lewis procedure) irrespective of neoadjuvant therapy 2.) Suitability of patient for MIN-E and HYBRID-E 3.) Age ≥ 18 years 4.) Ability of subject to understand character and individual consequences of the clinical trial Written informed consent

Exclusion Criteria

1.) Distant metastases 2.) Tumor localization above the azygos vein 3.) History of supraumbilical laparotomy or right thoracotomy within last three years 4.) American Society of Anesthesiologists (ASA)>3 5.) Hepatic cirrhosis Child B/C 6.) Participation in another interventional trial with interference of intervention and/or outcome of this trial 7.) Expected lack of compliance or language problems 8.) Participation in another intervention-trial with interference of intervention and outcome of this study

Addresses

Primary Sponsor

Klinik für Allgemeine, Viszeral- und Transplantationschirurgie Universitätsklinikum Tübingen
Prof. Dr. med. Andre Mihaljevic
Hoppe-Seyler-Strasse 3
72074 Tübingen
Germany
Telephone:
07071 2986620
Fax:
07071 29 5588
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Allgemeine, Viszeral- und Transplantationschirurgie Universitätsklinikum Tübingen
Prof. Dr. Andre Mihaljevic
Hoppe-Seyler-Strasse 3
72074 Tübingen
Germany
Telephone:
07071 2986620
Fax:
07071 29 5588
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Surgical Trial Unit Tübingen (STU)
Dr. rer. nat. Silvia Wagner
Hoppe-Seyler-Strasse 3
72074 Tübingen
Germany
Telephone:
07071 2983290
Fax:
+497071294485
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Allgemeine, Viszeral- und Transplantationschirurgie Universitätsklinikum Tübingen
Prof. Dr. Andre Mihaljevic
Hoppe-Seyler-Strasse 3
72074 Tübingen
Germany
Telephone:
07071 2986620
Fax:
07071 29 5588
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Bundesministerium für Bildung und Forschung Dienstsitz Bonn
Heinemannstr. 2
53175 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.bmbf.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Universität Ulm
Helmholtzstr. 20
89081 Ulm
Germany
Telephone:
+49-731-50022050
Fax:
+49-731-50022036
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2022-04-25
Ethics committee number:
175/22
Vote of the Ethics Committee:
Approved
Date of the vote:
2022-05-23

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1277-0214
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
Yes
IPD Sharing Plan:
Individual patient data can be made available in an anonymous form on request.

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry