NCT06281379

Brief Summary

Objective: To define complete mesogastric excision and compare our short term results for the first time in a different population. Study design:Randomised-controlled study Place and duration of the study: Gastroenterological Surgery Clinic,Health Sciences University,Basaksehir City Hospital,Istanbul,Turkey,from April to December 2023. Methodology: We compared short term results of open total gastrectomy+ mesogastrectomy with standard total gastrectomy + D2 lymph node dissection at a tertiary center in terms of peroperative results, histopathological findings and postoperative short- term outcomes with review of the literature. Conclusion: Our aim is to show that mesogastric excision is safe and has advantages over conventional D2 gastrectomy in means of not only peroperative and short-term outcomes, but also disease free survival.Our work is the first study from a different population of the world and our initial results can contribute to the literature for universalization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at below P25 for not_applicable gastric-cancer

Timeline
Completed

Started Apr 2023

Shorter than P25 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

April 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 17, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
Last Updated

February 28, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

February 17, 2024

Last Update Submit

February 25, 2024

Conditions

Gastric CancerGastric NeoplasmGastric Cancer Stage

Keywords

Gastric cancerD2 lymph node dissectionMesogastrectomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative outcome

    Complications

    Postoperative 1 week

Study Arms (2)

Group 1

EXPERIMENTAL

Total gastrectomy+mesogastrectomy

Procedure: Total mesogastrectomy

Group 2

OTHER

Total gastrectomy with concentional D2 lymphadenectomy

Procedure: Total mesogastrectomy

Interventions

Total mesogastrectomyPROCEDURE

More extended resection type with better oncological outcomes when compared to standard technique

Group 1Group 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histopathologically confirmed gastric adenocancer without evidence of distal metastasis and resectable tumors which have been treated with open total gastrectomy.

You may not qualify if:

  • Patients with prior upper gastrointestinal system surgery
  • Patients with neoadjuvant therapy
  • Patients with peripheral organ involvement and/or distant metastasis
  • Patients who underwent subtotal gastrectomy
  • Patients who underwent laparoscopic and robotic operations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yigit Duzkoylu

Istanbul, 34480, Turkey (Türkiye)

Location

Related Publications (4)

  • Xie D, Gao C, Lu A, Liu L, Yu C, Hu J, Gong J. Proximal segmentation of the dorsal mesogastrium reveals new anatomical implications for laparoscopic surgery. Sci Rep. 2015 Nov 6;5:16287. doi: 10.1038/srep16287.

    PMID: 26542081BACKGROUND

  • Girnyi S, Ekman M, Marano L, Roviello F, Polom K. Complete Mesogastric Excisions Involving Anatomically Based Concepts and Embryological-Based Surgeries: Current Knowledge and Future Challenges. Curr Oncol. 2021 Nov 22;28(6):4929-4937. doi: 10.3390/curroncol28060413.

    PMID: 34898586BACKGROUND

  • Shinohara H, Kurahashi Y, Haruta S, Ishida Y, Sasako M. Universalization of the operative strategy by systematic mesogastric excision for stomach cancer with that for total mesorectal excision and complete mesocolic excision colorectal counterparts. Ann Gastroenterol Surg. 2017 Oct 23;2(1):28-36. doi: 10.1002/ags3.12048. eCollection 2018 Jan.

    PMID: 29863126BACKGROUND

  • Xie D, Osaiweran H, Liu L, Wang X, Yu C, Tong Y, Hu J, Gong J. Mesogastrium: a fifth route of metastasis in gastric cancer? Med Hypotheses. 2013 Apr;80(4):498-500. doi: 10.1016/j.mehy.2012.12.020. Epub 2013 Feb 10.

    PMID: 23403142RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Study group participants: total gastrectomy+mesogastrectomy Control group: Standard total gastrectomy + D2 lymph node dissection
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2024

First Posted

February 28, 2024

Study Start

April 1, 2023

Primary Completion

December 31, 2023

Study Completion

January 1, 2024

Last Updated

February 28, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will share
Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
8 months

Locations

TU(1)