NCT06736847

Brief Summary

This study aims to evaluate lymph node metastasis and tumor deposit in the posterior gastric mesentery following distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
20mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress55%
May 2024Dec 2027

Study Start

First participant enrolled

May 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 1, 2024

Completed
4 months until next milestone

First Posted

Study publicly available on registry

December 17, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 2, 2025

Status Verified

August 1, 2025

Enrollment Period

3.7 years

First QC Date

September 1, 2024

Last Update Submit

August 25, 2025

Conditions

Keywords

Gastric cancerLymph node dissectionPosterior gastric mesenteryLymph node metastasis

Outcome Measures

Primary Outcomes (1)

  • Rate of lymph node metastasis and tumor deposit in the posterior gastric mesentery

    through study completion, an average of 1 year

Study Arms (1)

Radical gastrectomy with membrane dissection

Procedure: distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer

Interventions

distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision (CME) in gastric cancer

Radical gastrectomy with membrane dissection

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who met the above inclusion and exclusion criteria

You may qualify if:

  • Aged older than 18 years and younger than 85 years
  • Primary gastric adenocarcinoma confirmed by preoperative pathology result
  • cT2-4N0-3M0 at preoperative evaluation according to the American Joint 8 Committee on Cancer (AJCC) Cancer Staging Manual 7th Edition
  • Patients who received distal gastrectomy with D2 lymphadenectomy plus complete mesogastric excision
  • American Society of Anesthesiologists (ASA) class I, II, or III
  • Written informed consent

You may not qualify if:

  • Negative preoperative biopsy
  • Too late tumour stage or metastasis (cT4b/M1)
  • BMI\>30 kg/m2
  • Total gastrectomy or proximal gastrectomy
  • previous neoadjuvant chemotherapy or radiotherapy
  • Previous upper abdominal surgery
  • Combined with other malignant diseases
  • Reject operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Gastrointestinal Surgery, The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

MeSH Terms

Conditions

Stomach NeoplasmsLymphatic Metastasis

Interventions

Gastroenterostomy

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach DiseasesNeoplasm MetastasisNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anastomosis, SurgicalSurgical Procedures, OperativeDigestive System Surgical Procedures

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

September 1, 2024

First Posted

December 17, 2024

Study Start

May 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 2, 2025

Record last verified: 2025-08

Locations