Laparoscopic Versus Open Gastrectomy for Gastric Cancer

NCT ID: NCT02248519

Last Updated: 2020-09-04

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2023-12-31

Brief Summary

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This is the first randomized controlled trial comparing laparoscopic and open gastrectomy for resectable gastric cancer in a Western population. The hypothesis is that laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay. Secondarily that laparoscopic gastrectomy is hypothesized to be associated with lower post-operative morbidity and readmissions, higher cost-effectiveness, and better post-operative quality of life, with similar mortality and oncologic outcomes, compared to open gastrectomy. The study starts on 1 December 2014. Inclusion and follow-up will take three and five years respectively. Short-term results will be analyzed and published after discharge of the last randomized patient.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

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

Group Type ACTIVE_COMPARATOR

Open Gastrectomy

Intervention Type PROCEDURE

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.

Group Type EXPERIMENTAL

Laparoscopic Gastrectomy

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Histologically proven adenocarcinoma of the stomach
* 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

* Siewert type I esophagogastric junction tumor
* Non-elective surgery
* Previous gastric resection or recurrent gastric cancer
* Pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ZonMw: The Netherlands Organisation for Health Research and Development

OTHER

Sponsor Role collaborator

Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

UMC Utrecht

OTHER

Sponsor Role lead

Responsible Party

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Richard van Hillegersberg

MD PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Meander Medical Center

Amersfoort, , Netherlands

Site Status

VU University Medical Center

Amsterdam, , Netherlands

Site Status

Academic Medical Center

Amsterdam, , Netherlands

Site Status

Gelre Hospital

Apeldoorn, , Netherlands

Site Status

Catharina Hospital

Eindhoven, , Netherlands

Site Status

Leiden University Medical Center

Leiden, , Netherlands

Site Status

Erasmus Medical Center

Rotterdam, , Netherlands

Site Status

Zuyderland Medical Center

Sittard-Geleen, , Netherlands

Site Status

University Medical Center Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

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.

Reference Type BACKGROUND
PMID: 26219670 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37464143 (View on PubMed)

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.

Reference Type DERIVED
PMID: 37340107 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34581617 (View on PubMed)

Other Identifiers

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NL47444.041.14

Identifier Type: -

Identifier Source: org_study_id

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