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van CCT (UK)

Laparoscopic versus Open Gastrectomy: a multicenter randomized controlled trial

- candidate number19391
- NTR NumberNTR4767
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-sep-2014
- Secondary IDsNL47444.041.14  
- Public TitleLaparoscopic versus Open Gastrectomy: a multicenter randomized controlled trial
- Scientific TitleLaparoscopic versus Open Gastrectomy: a multicenter randomized controlled trial
- hypothesisLaparoscopic gastrectomy will result in a lower post-operative burden by means of shorter post-operative hospital stay
- Healt Condition(s) or Problem(s) studiedGastric carcinoma, Gastrectomy, Laparoscopy
- 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 criteriaExclusion criteria
• Siewert type I esophago-gastric junction tumor
• Prior gastric surgery
• Pregnancy
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2015
- planned closingdate1-jan-2023
- Target number of participants210
- InterventionsLaparoscopic or Open procedure for Total or Distal Gastrectomy
- Primary outcomeHospital stay
- Secondary outcomePost-operative morbidity
Oncologic outcome
Quality of life
- Timepoints- 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
- Trial web site
- statusplanned
- CONTACT for SCIENTIFIC QUERIESMD. PhD. R. Hillegersberg, van
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development, Johnson & Johnson
- PublicationsParkin DM, Bray F, Ferlay J, Pisani P. Global cancer statistics, 2002. CA Cancer J Clin. 2005 Mar-Apr;55(2):74-108. PubMed PMID: 15761078

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

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

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

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

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

Griffin SM. Gastric cancer in the East: same disease, different patient. Br J Surg. 2005 Sep;92(9):1055-6. PubMed PMID: 16106468

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

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

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

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

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

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
- Brief summaryFor 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.
- Main changes (audit trail)
- RECORD4-sep-2014 - 27-sep-2014

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