No registrations found.
ID
Source
Brief title
Health condition
Gastric Cancer, Gastrectomy, Laparoscopy
Maagkanker, Maagresectie, Laparoscopie
Sponsors and support
Johnson & Johnson
Intervention
Outcome measures
Primary outcome
Hospital stay
Secondary outcome
Post-operative morbidity
Mortality
Readmissions
Oncologic outcome
Quality of life
Cost-effectiveness
Background summary
For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of multi-modality treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, these studies were predominantly based on Asian populations, which show significant differences compared to Western populations. In this randomized controlled trial laparoscopic and open gastrectomy are compared in a Western population.
The design of the study is a non-blinded multicenter prospectively randomized controlled, superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be informed and included at the surgical outpatient department at one of the eight participating Dutch investigational centers and randomized to either laparoscopic or open gastrectomy. The primary outcome of this study is post-operative hospital stay (days).
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.
Study objective
Laparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay
Study design
- Hospital stay (in days). Timepoint: on discharge
- Post-operative morbidty (Clavien-Dindo). Timepoint: 5 years post-operative
- Mortality (1- and 5-year disease free survival rate). Timepoint: 5 years post-operative
- Readmissions (number of). Timepoint: 5 years post-operative
- Oncologic outcome (lymph nodes harvested and R0-resection rate). Timepoint: pathology report
- Quality of life (SF-36, EORTC QLQ-30 and EORTC QLQ-STO22). Timepoint: 6 weeks, 6, 12, 24, 36, 48, 60 months post-operative
- Cost-effectiveness (direct medical cost related to both strategies). Timepoint: 5 years post-operative
Intervention
Laparoscopic or Open procedure for Total or Distal Gastrectomy
Dept. of Surgery, G04.228
University Medical Center Utrecht
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88-755 8074
leonie.haverkamp@gmail.com
Dept. of Surgery, G04.228
University Medical Center Utrecht
Heidelberglaan 100
Utrecht 3584 CX
The Netherlands
+31 (0)88-755 8074
leonie.haverkamp@gmail.com
Inclusion criteria
• Histologically proven adenocarcinoma of the stomach
• Surgically resectable (cT1-4a, N0-3b, M0) tumor
• Age ≥ 18 years
• ECOG performance status 0,1 or 2.
• Written informed consent
Exclusion criteria
Exclusion criteria
• Siewert type I esophago-gastric junction tumor
• Prior gastric surgery
• Pregnancy
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4616 |
| NTR-old | NTR4767 |
| CCMO | NL47444.041.14 |
| OMON | NL-OMON47143 |
Summary results
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Hartgrink HH, van de Velde CJ, Putter H, Bonenkamp JJ, Klein Kranenbarg E, Songun I, Welvaart K, van Krieken JH, Meijer S, Plukker JT, van Elk PJ, Obertop H, Gouma DJ, van Lanschot JJ, Taat CW, de Graaf PW, von Meyenfeldt MF, Tilanus H, Sasako M. Extended lymph node dissection for gastric cancer: who may benefit? Final results of the randomized Dutch gastric cancer group trial. J Clin Oncol. 2004 Jun 1;22(11):2069-77. Epub 2004 Apr 13. PubMed PMID: 15082726
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Ronellenfitsch U, Schwarzbach M, Hofheinz R, Kienle P, Kieser M, Slanger TE, Jensen K; GE Adenocarcinoma Meta‐analysis Group. Perioperative chemo(radio)therapy versus primary surgery for resectable adenocarcinoma of the stomach, gastroesophageal junction, and lower esophagus. Cochrane Database Syst Rev. 2013 May 31;5:CD008107. doi: 10.1002/14651858.CD008107.pub2. Review. PubMed PMID: 23728671
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Japanese Gastric Cancer Association. Japanese gastric cancer treatment guidelines 2010 (ver. 3). Gastric Cancer. 2011 Jun;14(2):113-23. doi: 10.1007/s10120-011-0042-4. PubMed PMID: 21573742
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Haverkamp L, Weijs TJ, van der Sluis PC, van der Tweel I, Ruurda JP, van Hillegersberg R. Laparoscopic total gastrectomy versus open total gastrectomy for cancer: a systematic review and meta-analysis. Surg Endosc. 2013 May;27(5):1509-20. doi: 10.1007/s00464-012-2661-1. Epub 2012 Dec 14. Review. PubMed PMID: 23263644
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Dicken BJ, Bigam DL, Cass C, Mackey JR, Joy AA, Hamilton SM. Gastric adenocarcinoma: review and considerations for future directions. Ann Surg. 2005 Jan;241(1):27-39. Review. PubMed PMID: 15621988
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Griffin SM. Gastric cancer in the East: same disease, different patient. Br J Surg. 2005 Sep;92(9):1055-6. PubMed PMID: 16106468
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Fein M, Fuchs KH, Thalheimer A, Freys SM, Heimbucher J, Thiede A. Long-term benefits of Roux-en-Y pouch reconstruction after total gastrectomy: a randomized trial. Ann Surg. 2008 May;247(5):759-65. doi: 10.1097/SLA.0b013e318167748c. PubMed PMID: 18438112
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Shim JH, Oh SI, Yoo HM, Jeon HM, Park CH, Song KY. Roux-en-Y Gastrojejunostomy After Totally Laparoscopic Distal Gastrectomy: Comparison With Billorth II Reconstruction. Surg Laparosc Endosc Percutan Tech. 2014 Apr 4. [Epub ahead of print] PubMed PMID: 24710243
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Lee JH, Lee HJ, Kong SH, Park do J, Lee HS, Kim WH, Kim HH, Yang HK. Analysis of the lymphatic stream to predict sentinel nodes in gastric cancer patients. Ann Surg Oncol. 2014 Apr;21(4):1090-8. doi: 10.1245/s10434-013-3392-9. Epub 2013 Nov 26. PubMed PMID: 24276637
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Mortensen K, Nilsson M, Slim K, Schäfer M, Mariette C, Braga M, Carli F, Demartines N, Griffin SM, Lassen K; the Enhanced Recovery After Surgery (ERAS®) Group. Consensus guidelines for enhanced recovery after gastrectomy: Enhanced Recovery After Surgery (ERAS®) Society recommendations. Br J Surg. 2014 Jul 21. doi: 10.1002/bjs.9582. [Epub ahead of print] PubMed PMID: 25047143
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Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. PubMed PMID: 15273542
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Haverkamp L, Ruurda JP, van der Sluis PC, van Hillegersberg R. [Surgical treatment of gastric cancer: focus on centralisation and laparoscopic resections]. Ned Tijdschr Geneeskd. 2013;157(35):A5864. Review. Dutch. PubMed PMID: 23985239