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NCT06748690
MCB vs EUS-FNA for Preoperative Pathological Evaluation of Gastric SMT
NA trial testing mucosal cutting biopsy in Gastrointestinal Stromal Tumor of Stomach in 96 participants. Currently enrolling.
30 June 2026
Quick facts
| Lead sponsor | Peking University People's Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | diagnostic |
| Enrollment | 96 |
| Start date | 1 January 2024 |
| Primary completion | 30 June 2026 |
| Estimated completion | 31 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- mucosal cutting biopsy
- endoscopic ultrasound-guided-fine needle aspiration
Conditions studied
- Gastrointestinal Stromal Tumor of Stomach — all drugs for Gastrointestinal Stromal Tumor of Stomach →
- Submucosal Tumor of Stomach — all drugs for Submucosal Tumor of Stomach →
Sponsor
Peking University People's Hospital
Who can join
18 and older, any sex, with Gastrointestinal Stromal Tumor of Stomach or Submucosal Tumor of Stomach. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Gastrointestinal stromal tumors (GISTs) are the most common submucosal tumors (SMTs) of the stomach. The 2022 European Society of Oncology ESMO Diagnosis and Treatment Guidelines recommend that GISTs undergo biopsy with a clear pathological diagnosis and should be removed unless there are significant complications. But currently, the diagnostic rate of EUS-FNA for upper gastrointestinal subcutaneous lesions is less than 60%. In recent years, mucosal cutting biopsy (MCB) has become an effective method for diagnosing SMTs. Regardless of whether the SMTs are large or small, the application of MCB technology can quickly obtain pathological tissue under direct visualization, and its immunohistochemical pathological diagnosis rate is relatively satisfactory. MCB technology has great potential in the biopsy of SMTs, but there is currently no comparison of results between two technologies in randomized controlled trials. The purpose of this study is to design a randomized controlled trial to compare the diagnostic rates of EUS-FNA and MCB techniques for tissue pathology (including immunohistochemistry) of SMTs, in order to improve the diagnostic accuracy of SMTs in our hospital and improve patient prognosis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06748690
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06748690 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Peking University People's Hospital
- Last refreshed: 16 April 2026
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