NCT02130726

Brief Summary

Laparoscopic surgery has been shown to provide important advantages in comparison with open procedures in the treatment of several malignant diseases, such as less peri-operative blood loss, faster patient recovery and shorter hospital stay. All while maintaining similar results with regard to tumour resection margin and oncological survival. In gastric cancer the role of laparoscopic surgery remains unclear. Current recommended treatment for gastric cancer consists of radical resection of the stomach, combined with lymfadenectomy. The extent of lymfadenectomy is considered a marker for radicality of surgery and quality of care. Therefore, It is imperative that a new surgical technique should be non-inferior with regard to radicality and lymph node yield. Preliminary studies show promising results for laparoscopic gastrectomy, but the number of studies is small and due to lower incidence of gastric cancer in the West they are often underpowered. A prospective randomised clinical trial is indicated in order to establish the optimal surgical technique in gastric cancer: open versus minimally invasive gastrectomy. Results of the STOMACH trial will further aid in determining the optimal surgical technique in patients with gastric cancer.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P25-P50 for not_applicable gastric-cancer

Timeline
Completed

Started Dec 2014

Typical duration for not_applicable gastric-cancer

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 28, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

4.2 years

First QC Date

April 28, 2014

Last Update Submit

July 16, 2019

Conditions

Gastric Cancer

Keywords

Gastric cancerMinimally-invasiveOncological quality of resection

Outcome Measures

Primary Outcomes (1)

  • Extent of lymph node dissection

    The extent of lymph node dissection in treatment of gastric cancer is considered a prognostic marker for postoperative survival and disease-free survival. Before implementation of a new surgical technique, it is imperative that this technique is non-inferior with regard to the extent of lymph node dissection. Measures will include the number of resected lymph nodes and the number of resected lymph node stations.

    two weeks

Secondary Outcomes (8)

  • Postoperative complications

    Postoperatively with follow-up to one year

  • Quality of Life

    1 and 5 days postoperatively, 3 months, 6 months and 12 months

  • Duration of hospital admission

    during admission, average 2 weeks

  • Duration of Intensive Care admission

    During submission, average 2 days

  • Peri-operative blood loss

    during surgery, 1 day

  • +3 more secondary outcomes

Study Arms (2)

Minimally-invasive Gastrectomy

EXPERIMENTAL

Patients allocated to the 'Minimally-invasive Gastrectomy' group will undergo minimally-invasive/laparoscopic total gastrectomy. If, during surgery, laparoscopic resection does not seem feasible, the procedure may be converted to an open one.

Procedure: Minimally-invasive gastrectomy

Open Gastrectomy

ACTIVE COMPARATOR

Patients allocated to the 'Open Gastrectomy' group will receive total resection of the stomach via laparotomy. This group is considered the control group

Procedure: Open Gastrectomy

Interventions

Minimally-invasive gastrectomyPROCEDURE

Patients allocated to the 'Minimally-invasive gastrectomy' arm will receive total gastrectomy via laparoscopy.

Also known as: laparoscopic gastrectomy
Minimally-invasive Gastrectomy
Open GastrectomyPROCEDURE

patients allocated to the 'Open gastrectomy' group will receive total gastrectomy via laparotomy

Also known as: Conventional Gastrectomy
Open Gastrectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age equal to or above 18 years
  • Primary adenocarcinoma of stomach, indication for total gastrectomy with curative intent.
  • Neoadjuvant therapy (epirubicin, cisplatin, capecitabine)
  • Surgical resectable (T1-3, N0-1, M0)
  • Informed consent

You may not qualify if:

  • Previous or coexisting cancer
  • Previous surgery of the stomach
  • ASA classification (American Society of Anaesthesiologists) score 4 or higher

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Universitätsklinikum Carl Gustav Carus

Dresden, Germany

Location

VU Medical Center

Amsterdam, NLNH, 1081HV, Netherlands

Location

Academic Medical Centre

Amsterdam, North Holland, 1105AZ, Netherlands

Location

Hospital universitari Basurto

Bilbao, Spain

Location

Hospital Jerez de la Frontera

Cadiz, Spain

Location

Hospital Universitario de Josep Trueta

Girona, Spain

Location

Hospital Universitario del Sureste de Madrid

Madrid, Spain

Location

Salford Royal NHS Foundation Trust

Manchester, United Kingdom

Location

Related Publications (2)

  • van der Wielen N, Daams F, Rosati R, Parise P, Weitz J, Reissfelder C, Del Val ID, Loureiro C, Parada-Gonzalez P, Pintos-Martinez E, Vallejo FM, Achirica CM, Sanchez-Pernaute A, Campos AR, Bonavina L, Asti ELG, Poza AA, Gilsanz C, Nilsson M, Lindblad M, Gisbertz SS, van Berge Henegouwen MI, Romario UF, De Pascale S, Akhtar K, Cuesta MA, van der Peet DL, Straatman J. Three-year survival and distribution of lymph node metastases in gastric cancer following neoadjuvant chemotherapy: results from a European randomized clinical trial. Surg Endosc. 2023 Sep;37(9):7317-7324. doi: 10.1007/s00464-023-10278-5. Epub 2023 Jul 19.

    PMID: 37468751DERIVED

  • Straatman J, van der Wielen N, Cuesta MA, Gisbertz SS, Hartemink KJ, Alonso Poza A, Weitz J, Mateo Vallejo F, Ahktar K, Diez Del Val I, Roig Garcia J, van der Peet DL. Surgical techniques, open versus minimally invasive gastrectomy after chemotherapy (STOMACH trial): study protocol for a randomized controlled trial. Trials. 2015 Mar 27;16:123. doi: 10.1186/s13063-015-0638-9.

    PMID: 25873249DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • D.L. van der Peet, MD, PhD

    VU Medisch Centrum

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

April 28, 2014

First Posted

May 5, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2019

Study Completion

June 1, 2019

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations

GB(1)NL(2)ES(4)DE(1)