Trial document





This trial has been registered retrospectively.
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  DRKS00011676

Trial Description

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Title

Minivally Invasive versus OPen esophagectomy - comparision of short- and long-term outcome

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Trial Acronym

MICOP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

The study investigates the differences in between a minimally invasive ("keywhole surgery") and an open ("normal incision") removal of the esophageus in patients with esophageal cancer. Endpoints are the duration of hospital stay, the duration of intensive care Treatment and the frequency of complications.

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Brief Summary in Scientific Language

The study investigates the differences in perioperative morbidity between a minimal-invasive and an open esophagectomy in patients with esophageal cancer. Two patient cohorts will be non-randomized allocated to either to the intervention or control group. The number of patients in each group is planned with n=20, allocation to the interventionell Group has already started and allocation to the control group will start in the near future. Beside the procedure both groups will be treated the same way according to a standarized postoperative protocol. This study does not test a novel therapy but compares to well estabilshed procedures with focus on oncological parameters (R0-resection rate, number of harvested lymph nodes) and surgical-clinical aspects (duration of surgery, length of hospital stay, postoperative complications). This study is a non-randomized controlled interventional study with comparison of two patient cohorts.

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Organizational Data

  •   DRKS00011676
  •   2017/03/31
  •   [---]*
  •   yes
  •   Approved
  •   S-635/2013, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C15.5 -  Malignant neoplasm: Lower third of oesophagus
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Interventions/Observational Groups

  •   minimally invasive esophagectomy
  •   abdomino-thoracic esophagectomy
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Characteristics

  •   Interventional
  •   [---]*
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Other
  •   I-II
  •   N/A
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Primary Outcome

Postoperative Morbidity 30 days after surgery

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Secondary Outcome

Frequency of R0-resections
Number of resected lymph nodes

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2016/08/15
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

≥ 18 years of age
Gastrointestinal malignancy of the distal esophagus
Resectable primary tumor
Operation in curative intention
Patient considered to tolerate surgery in both intervention groups

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Exclusion Criteria

•Suspected tumor infiltration or contact to adjacent organs (cT4-/uT4-category)
•Tumor localization above the V. azygos
•Emergency procedure due to perforation or bleeding

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergAbteilung für Allgemein, Viszeral- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.   Beat  Müller 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Universitätsklinikum HeidelbergAbteilung für Allgemein, Viszeral- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.   Beat  Müller 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.