Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00015243

Trial Description

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Title

Laparoscopic vs. open gastrectomy for gastric cancer

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Trial Acronym

LaKoGast

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URL of the Trial

http://under construction

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Brief Summary in Lay Language

Laparoscopic gastric cancer surgery is an established approach in Asian countries, especially in Japan and Korea. Several studies and meta-analysis from this regions have demonstrated the known advantages of laparoscopic gastric surgery compared to open surgery and showed significant faster early postoperative reconvalescence and equal or less morbidity and letality.
Compared to Western countries we realise much different patient characteristics and comorbidities. This study is created to compare outcome and quality of laparoscopic gastrectomy and conventional open gastrectomy under Western/ Europaen conditions.

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Brief Summary in Scientific Language

All patients older 18 years and histopathologic proven diagnosis of gastric cancer without metastasis (uT1b-uT4, uN0-3, uM0 according to UICC) will be randomized into two study-arms:
A - Treatment with conventionell open gastrectomy or subtotal (4/5) gastrectomy (OG)
B - Treatment with laparoscopic gastrectomy or subtotal (4/5) gastrectomy (LG).
Extent of surgery (gastrectomy or subtotal gastrectomy) depends in both arms on size and location of gastric cancer.

Application of chemotherapy is done guidelines compiant in all tumor stages >uT3 and eventually uT2N+.
Chemotherapy will be documented included toxicity but is not part of analysis.

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Organizational Data

  •   DRKS00015243
  •   2018/09/20
  •   [---]*
  •   yes
  •   Approved
  •   A 2018-0088, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
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Secondary IDs

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

  •   gastrocarcinoma
  •   C16 -  Malignant neoplasm of stomach
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Interventions/Observational Groups

  •   conventionell open gastrectomy
  •   laparoscopic gastrectomy
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Characteristics

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

Faster postoperative recovery for patients with laparoscopic gastrectomy (earlier mobilization, accelerated oral fluid intake, shorter time to first flatus)

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Secondary Outcome

1. equal safety of laparoscopic approach like open gastrectomy (morbidity-CLAVIEN and mortality),
2. equal (not higher) postoperative morbidity of laparoscopic gastrectomy,
3. equal oncological results and long-term outcome (overall survival, desease free survival)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2018/06/01
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Patients with first diagnosis of gastric cancer, preoperative tumorstaging UICC uT1b-uT4 uN0-3, uM0,
preoperative tumorconference consens,
age>18,
ASA <IV,
ECOG <2,
patient agreement

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Exclusion Criteria

other carcinoma, except CIS cervix uteri and dermatologic tumors in early stages and "cured" carcinoma with a period of at least 10 year recurrence free survival,
UICC IV,
participation in other studies,
non complience

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Allgemein-, Viszeral-, Thorax- und GefäßchirurgieKlinikum Südstadt Rostock
    • Mr.  Prof. Dr.  Kaja  Ludwig 
    • Südring 81
    • 18057  Rostock
    • Germany
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    • Klinik für Allgemein-, Viszeral-, Thorax- und GefäßchirurgieKlinikum Südstadt Rostock
    • Mr.  Prof. Dr.  Kaja  Ludwig 
    • Südring 81
    • 18057  Rostock
    • Germany
    end of 1:1-Block address scientific-contact
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    end of 1:1-Block address contact scientific-contact
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    • Klinik für Allgemein-, Viszeral-, Thorax- und GefäßchirurgieKlinikum Südstadt Rostock
    • Mr.  Prof. Dr.  Kaja  Ludwig 
    • Südring 81
    • 18057  Rostock
    • Germany
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Sources of Monetary or Material Support

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    • Klinikum Südstadt Rostock
    • Mr.  Prof. Dr.  Kaja  Ludwig 
    • Südring 81
    • 18057  Rostock
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.