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Clinical Trials/NCT06640153
NCT06640153Active, not recruitingNot Applicable

Preoperative Evaluation of Resectability in Gastroesophageal Junction and Upper Gastric Adenocarcinoma Utilizing Multi-Parametric MRI and CT Imaging.

The First Affiliated Hospital with Nanjing Medical University1 site in 1 country100 target enrollmentStarted: August 21, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
100
Locations
1
Primary Endpoint
Siewert classification

Study Overview

Brief Summary

Accurate preoperative Siewert classification, precise assessment of the extent of esophageal involvement, and staging is crucial for determining the appropriate surgical approach and achieving negative resection margins. The purpose of this study is to investigate the diagnostic performance of the Multi-parametric magnetic resonance imaging (mpMRI) and computed tomography (CT) in gastroesophageal junction and upper gastric cancers.

Detailed Description

Despite a continuous decline in the incidence of gastric cancer in recent years, the morbidity and mortality rates associated with the gastroesophageal junction and upper gastric cancers remain elevated. Consequently, it is imperative to develop more refined and individualized precision strategies for screening, diagnosis, surgical intervention, and comprehensive treatment. Due to the unique anatomical location, considerable debate exists regarding the critical aspects of its surgical management in clinical practice. Multiparametric MRI offers significant anatomical benefits due to its high soft tissue resolution, and its functional imaging capabilities present promising applications. With advancements in abdominal imaging technology, novel techniques such as high-order diffusion imaging and compressed sensing technology have facilitated high-resolution MRI of the stomach during free breathing, which is now implemented in clinical practice. Prior research has demonstrated that individualized gastric MRI scanning consistently yields superior image quality, and MRI provides greater accuracy than CT in preoperative staging assessments. Nonetheless, the comparative study of MRI and CT in patients with gastroesophageal junction and upper gastric cancers remains to be elucidated.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 85 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • patients with gastric cancer confirmed by preoperative gastroscopic biopsy;
  • underwent standardized mpMRI and CT examination;
  • patients with complete postoperative pathological data and pathological results of gastroesophageal Junction or upper gastric adenocarcinoma;

Exclusion Criteria

  • combined with other tumors;
  • Clinical and imaging data were missing or could not meet the research needs;
  • the location of lesions could not be determined;

Outcomes

Primary Outcomes

Siewert classification

Time Frame: 2 years

Compare the findings of multiparametric MRI and CT in the Siewert classification (Types I, II, and III) against a histopathological reference standard, evaluating sensitivity, specificity, positive predictive value, and negative predictive value.

length of esophageal involvement

Time Frame: 2 years

The accuracy and AUC of length of esophageal involvement (not involved, 0-2cm, 2-3cm, 3-4cm, \>4cm) evaluated by CT and MRI.

Staging

Time Frame: 2 years

Compare the cancer stage (according to AJCC 8th edition TNM-classification) as determined by mpMRI compared to CT at primary staging and at restaging. The proportion of upgraded, downgraded, and right patients are determined.

Secondary Outcomes

  • The number of patients with complications(Within 30 days after the day of operation)
  • Survival time and recurrence time(3 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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