Laparoscopic Versus Open Gastrectomy for Gastric Cancer
NCT ID: NCT02248519
Last Updated: 2020-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
210 participants
INTERVENTIONAL
2014-12-31
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Open Gastrectomy
Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
Open Gastrectomy
Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
Laparoscopic Gastrectomy
Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy.
Laparoscopic Gastrectomy
Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. If laparoscopic resection does not seem feasible during surgery, the procedure may be converted to an open gastrectomy.
Interventions
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Open Gastrectomy
Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
Laparoscopic Gastrectomy
Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. If laparoscopic resection does not seem feasible during surgery, the procedure may be converted to an open gastrectomy.
Eligibility Criteria
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Inclusion Criteria
* Surgically resectable (cT1-4a, N0-3b, M0) tumor
* Age ≥ 18 years
* European Clinical Oncology Group (ECOG) performance status 0, 1 or 2.
* Written informed consent
Exclusion Criteria
* Non-elective surgery
* Previous gastric resection or recurrent gastric cancer
* Pregnancy
18 Years
ALL
No
Sponsors
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ZonMw: The Netherlands Organisation for Health Research and Development
OTHER
Johnson & Johnson
INDUSTRY
UMC Utrecht
OTHER
Responsible Party
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Richard van Hillegersberg
MD PhD
Principal Investigators
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Richard van Hillegersberg, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Dept. of Surgery, University Medical Center Utrecht
Locations
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Zorggroep Twente Almelo
Almelo, , Netherlands
Meander Medical Center
Amersfoort, , Netherlands
VU University Medical Center
Amsterdam, , Netherlands
Academic Medical Center
Amsterdam, , Netherlands
Gelre Hospital
Apeldoorn, , Netherlands
Catharina Hospital
Eindhoven, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Zuyderland Medical Center
Sittard-Geleen, , Netherlands
University Medical Center Utrecht
Utrecht, , Netherlands
Countries
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References
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Haverkamp L, Brenkman HJ, Seesing MF, Gisbertz SS, van Berge Henegouwen MI, Luyer MD, Nieuwenhuijzen GA, Wijnhoven BP, van Lanschot JJ, de Steur WO, Hartgrink HH, Stoot JH, Hulsewe KW, Spillenaar Bilgen EJ, Rutter JE, Kouwenhoven EA, van Det MJ, van der Peet DL, Daams F, Draaisma WA, Broeders IA, van Stel HF, Lacle MM, Ruurda JP, van Hillegersberg R; LOGICA study group. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial). BMC Cancer. 2015 Jul 29;15:556. doi: 10.1186/s12885-015-1551-z.
van der Veen A, Ramaekers M, Marsman M, Brenkman HJF, Seesing MFJ, Luyer MDP, Nieuwenhuijzen GAP, Stoot JHMB, Tegels JJW, Wijnhoven BPL, de Steur WO, Kouwenhoven EA, Wassenaar EB, Draaisma WA, Gisbertz SS, van der Peet DL, May AM, Ruurda JP, van Hillegersberg R; LOGICA study group. Pain and Opioid Consumption After Laparoscopic Versus Open Gastrectomy for Gastric Cancer: A Secondary Analysis of a Multicenter Randomized Clinical Trial (LOGICA-Trial). J Gastrointest Surg. 2023 Oct;27(10):2057-2067. doi: 10.1007/s11605-023-05728-3. Epub 2023 Jul 18.
de Jongh C, van der Veen A, Brosens LAA, Nieuwenhuijzen GAP, Stoot JHMB, Ruurda JP, van Hillegersberg R; LOGICA Study Group. Distal Versus Total D2-Gastrectomy for Gastric Cancer: a Secondary Analysis of Surgical and Oncological Outcomes Including Quality of Life in the Multicenter Randomized LOGICA-Trial. J Gastrointest Surg. 2023 Sep;27(9):1812-1824. doi: 10.1007/s11605-023-05683-z. Epub 2023 Jun 20.
van der Veen A, Brenkman HJF, Seesing MFJ, Haverkamp L, Luyer MDP, Nieuwenhuijzen GAP, Stoot JHMB, Tegels JJW, Wijnhoven BPL, Lagarde SM, de Steur WO, Hartgrink HH, Kouwenhoven EA, Wassenaar EB, Draaisma WA, Gisbertz SS, van der Peet DL, May AM, Ruurda JP, van Hillegersberg R; LOGICA Study Group. Laparoscopic Versus Open Gastrectomy for Gastric Cancer (LOGICA): A Multicenter Randomized Clinical Trial. J Clin Oncol. 2021 Mar 20;39(9):978-989. doi: 10.1200/JCO.20.01540. Epub 2021 Jan 6.
Other Identifiers
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NL47444.041.14
Identifier Type: -
Identifier Source: org_study_id
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