Evidence map›Paper›PMID 25873249›Full record

Trial reportTrials2015

Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial.

Jennifer Straatman, Nicole van der Wielen, Miguel A Cuesta, Suzanne S Gisbertz, Koen J Hartemink, Alfredo Alonso Poza, Jürgen Weitz, Fransico Mateo Vallejo, Khurshid Ahktar, Ismael Diez Del Val and 2 more

Registry-linked trialOpen access · goldAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02130726 (The STOMACH Trial), which is not on this map. Cited by 23 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 5 pooled it
5.5field-weighted citation impact, top 4% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02130726 nacompletednot on this map

The STOMACH Trial: Surgical Technique, Open Versus Minimally-invasive Gastrectomy After CHemotherapy

TypeinterventionalSponsorAmsterdam UMC, location VUmcRan2014 to 2019Enrolled110ConditionsGastric CancerArmsMinimally-invasive gastrectomy, Open Gastrectomy
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 5 syntheses or guidelines pooled it, 62 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Short-term outcomes in minimally invasive versus open gastrectomy: the differences between East and West. A systematic review of the literature.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2018
    Pooled it
  4. Laparoscopic versus open gastrectomy for gastric cancer.The Cochrane database of systematic reviews · 2016
    Pooled it
  5. Pooled it
  6. Trial
  7. Open versus minimally invasive total gastrectomy after neoadjuvant chemotherapy: results of a European randomized trial.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2021
    Trial
  8. Article
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Article
  15. Article
  16. Effect of laparoscopicTranslational gastroenterology and hepatology · 2019
    Article
  17. Review
  18. Review
  19. Factors influencing health-related quality of life after gastrectomy for cancer.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2018
    Article
  20. Safety and feasibility of minimally invasive gastrectomy during the early introduction in the Netherlands: short-term oncological outcomes comparable to open gastrectomy.Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2017
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

12 authors at 9 institutions in 4 countries.

Jennifer StraatmanDepartment of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, NL, Netherlands. je.straatman@vumc.nl.
Nicole van der WielenDepartment of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, NL, Netherlands. ni.vanderwielen@vumc.nl.
Miguel A CuestaDepartment of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, NL, Netherlands. ma.cuesta@vumc.nl.
Suzanne S GisbertzDepartment of Surgery, Academic Medical Center, Meibergdreef 9, 1105 AZ, Amsterdam, NL, Netherlands. s.s.gisbertz@amc.uva.nl.
Koen J HarteminkDepartment of Surgery, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, NL, Netherlands. k.hartemink@nki.nl.
Alfredo Alonso PozaDepartment of Surgery, Hospital Universitario del Sureste, Ronda del Sur 10, Arganda del Rey, 28500, Madrid, ES, Spain. alfredo.alonsop@salud.madrid.org.
Jürgen WeitzDepartment of Surgery, Uniklinikum Dresden, Fetscherstraße 74, 01307, Dresden, DE, Germany. Juergen.Weitz@uniklinikum-dresden.de.
Fransico Mateo VallejoDepartment of Surgery, Hospital Jerez de la Frontera, Ronda de Circunvalación, 11407, Cadiz, ES, Spain. fasismateo@gmail.com.
Khurshid AhktarDepartment of Surgery, Salford Royal NHS Foundation Trust, Stott lane, Salford, M6 8HD, UK. khurshid.akhtar@srft.nhs.uk.
Ismael Diez Del ValDepartment of Surgery, Hospital Universitario Basurto, Montevideo Etorbidea 18, 48013, Bilbao, Spain. ismael.diezdelval@osakidetza.net.
Josep Roig GarciaDepartment of Surgery, Hospital Universitario de Josep Trueta, Avenida França, 17007, Girona, ES, Spain. jroigg@ono.com.
Donald L van der PeetDepartment of Surgery, VU University Medical Center, De Boelelaan 1117, 1081 HV, Amsterdam, NL, Netherlands. d.vdpeet@vumc.nl.
Amsterdam UMC Location VUmc · NLAcademic Medical Center · NLHospital de Basurto · ESHospital Jerez Puerta del Sur · ESHospital Universitari de Girona Doctor Josep Trueta · ESHospital Universitario del Sureste · ESKlinik und Poliklinik für Psychotherapie und Psychosomatik · DESalford Royal NHS Foundation Trust · GBThe Netherlands Cancer Institute · NL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLaparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less perioperative blood loss and faster patient recovery. It also maintains similar results with regard to tumor resection margins and oncological long-term survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, with a free margin of 5 to 6 cm from the tumor, combined with a lymphadenectomy. The extent of the lymphadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, it is imperative that a novel surgical technique, such as minimally invasive total gastrectomy, should be non-inferior with regard to radicality of surgery and lymph node yield. METHODS/

designThe Surgical Techniques, Open versus Minimally invasive gastrectomy After CHemotherapy (STOMACH) study is a randomized, clinical multicenter trial. All adult patients with primary carcinoma of the stomach, in which the tumor is considered surgically resectable (T1-3, N0-1, M0) after neo-adjuvant chemotherapy, are eligible for inclusion and randomization. The primary endpoint is quality of oncological resection, measured by radicality of surgery and number of retrieved lymph nodes. The pathologist is blinded towards patient allocation. Secondary outcomes include patient-reported outcomes measures (PROMs) regarding quality of life, postoperative complications and cost-effectiveness. Based on a non-inferiority model for lymph node yield, with an average lymph node yield of 20, a non-inferiority margin of -4 and a 90% power to detect non-inferiority, a total of 168 patients are to be included. DISCUSSION: The STOMACH trial is a prospective, multicenter, parallel randomized study to define the optimal surgical strategy in patients with proximal or central gastric cancer after neo-adjuvant therapy: the conventional 'open' approach or minimally invasive total gastrectomy.

trial registrationThis trial was registered on 28 April 2014 at Clinicaltrials.gov with the identifier NCT02130726 .

Indexed as

Minimally Invasive Surgical ProceduresAdultClinical ProtocolsGastrectomyHumansLymph Node ExcisionProspective StudiesStomach Neoplasms

Identifiers

PMID25873249
PMCPMC4397942
OpenAlexW2167305219

What OpenQuestion holds

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LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.