Gastrointestinal Stromal Tumor of StomachNCT06748690
MCB vs EUS-FNA for Preoperative Pathological Evaluation of Gastric SMT
A study testing mucosal cutting biopsy and endoscopic ultrasound-guided-fine needle aspiration in people with Gastrointestinal Stromal Tumor of Stomach and Submucosal Tumor of Stomach, run by Peking University People's Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Stromal Tumor of Stomach, Submucosal Tumor of Stomach
- What is being tested?
- mucosal cutting biopsy and endoscopic ultrasound-guided-fine needle aspiration
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Endoscopic evaluation considers gastric submucosal tumors (SMTs) with a diameter of ≥ 15mm
Who cannot join
- Endoscopic non bulging lesions.
- The upper gastrointestinal lesions measured by Endoscopic Ultrasonography(EUS) are less than 15 mm.
- Lesions that do not require tissue collection (such as lipomas, varicose veins)
- Patients with cystic lesions
- The patient has uncorrectable coagulation dysfunction (International Normalized Ratio (INR)>1.5 or platelet count<50x109)
- Patients with portal hypertension
Show all 9Show fewer
- Patients with a history of upper gastrointestinal surgery
- Pregnant women
- Patients who refuse to participate in this clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Liming Zhang, M.D., 8613671027761, zhlim315@163.com
About this study
Official title: Comparison of Endoscopic Mucosal Cutting Biopsy and Endoscopic Ultrasound-guided-fine Needle Aspiration for Preoperative Pathological Evaluation of Gastric Submucosal Tumors
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.
- Being tested
- mucosal cutting biopsy, endoscopic ultrasound-guided-fine needle aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mucosal cutting biopsyProcedure or surgery
Under intravenous anesthesia, the patient inserted a gastroscopy (Olympus GIF-260J) through the mouth and used a disposable high-frequency cutting knife to cut open the surface mucosa of the tumor. Biopsy forceps were used to extract tissue that could be fully evaluated for pathological examination. Use a disposable hemostatic clip to suture the mucosal incision, and after thorough observation of the hemostasis, withdraw from the endoscope.
(
endoscopic ultrasound-guided-fine needle aspirationProcedure or surgery
- EUS-FNA group: Standard (Endoscopic Ultrasonography-Guided Fine-Needle Aspiration) EUS-FNA technology was used, and electronic linear array ultrasound endoscopy (GF-UCT-260, Olympus, Japan) was used to scan and locate the lesion. Puncture needle (Boston Scientific, USA) was used for aspiration biopsy. The thickness of the puncture needle depends on the size, hardness, and location of the tumor.
| Study group | Role | What they receive |
|---|---|---|
| MCB group | Experimental | Use a disposable high-frequency cutting knife under endoscopy to cut open the surface mucosa of the tumor, and use biopsy forceps to extract tissue that can be fully evaluated for pathological examination. Use a disposable hemostatic clip to suture the mucosal incision, and after thorough observation of the hemostasis, withdraw from the endoscope. Receives: Procedure: mucosal cutting biopsy |
| EUS-FNA group | Active comparator | Using standard Endoscopic Ultrasonography-Guided Fine-Needle Aspiration(EUS-FNA) technology, using endoscopic ultrasound scanning to locate lesions, and puncture needle aspiration biopsy. Receives: Procedure: endoscopic ultrasound-guided-fine needle aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological diagnosis and immunohistochemical diagnosis
Comparison of diagnostic yield between Mucosal Cutting Biopsy (MCB) and Endoscopic Ultrasonography-Guided Fine-Needle Aspiration (EUS-FNA) The diagnostic yield was defined as the percentage of lesions confirmed by a pathologic diagnosis involving immunohistological analysis.
Measured: Pathological evaluation should be conducted immediately after specimen isolation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Gastrointestinal Stromal Tumor of StomachStudies of the same condition, open and under way.
- More trials run by Peking University People's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Liming, Peking University People's Hospital
- Investigators
- Liming Zhang, M.D., Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06748690
- Sponsor's protocol ID
- RDL-13
- Status last verified
- May 2025
- First submitted
- 19 Dec 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dhaliwal A, Kolli S, Dhindsa BS, Devani K, Ramai D, Sayles H, Rangray R, Bhat I, Singh S, Adler DG. Clinical efficacy and safety of mucosal incision-assisted biopsy for the diagnosis of upper gastrointestinal subepithelial tumors: A systematic review and meta-analysis. Ann Gastroenterol. 2020 Mar-Apr;33(2):155-161. doi: 10.20524/aog.2020.0460. Epub 2020 Feb 14.
PubMed 32127736Fernandez-Esparrach G, Sendino O, Sole M, Pellise M, Colomo L, Pardo A, Martinez-Palli G, Arguello L, Bordas JM, Llach J, Gines A. Endoscopic ultrasound-guided fine-needle aspiration and trucut biopsy in the diagnosis of gastric stromal tumors: a randomized crossover study. Endoscopy. 2010 Apr;42(4):292-9. doi: 10.1055/s-0029-1244074. Epub 2010 Mar 30.
PubMed 20354939Sanaei O, Fernandez-Esparrach G, De La Serna-Higuera C, Carrara S, Kumbhari V, El Zein MH, Ismail A, Gines A, Sendino O, Montenegro A, Repici A, Rahal D, Brewer Gutierrez OI, Moran R, Yang J, Parsa N, Paiji C, Aghaie Meybodi M, Shin EJ, Lennon AM, Kalloo AN, Singh VK, Canto MI, Khashab MA. EUS-guided 22-gauge fine needle biopsy versus single-incision with needle knife for the diagnosis of upper gastrointestinal subepithelial lesions: a randomized controlled trial. Endosc Int Open. 2020 Mar;8(3):E266-E273. doi: 10.1055/a-1075-1900. Epub 2020 Feb 21.
PubMed 32118100
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Endoscopic Mucosal Cutting Biopsy and Endoscopic Ultrasound-guided-fine Needle Aspiration for Preoperative Pathological Evaluation of Gastric Submucosal Tumors
- ClinicalTrials.gov ID
- NCT06748690
- Acronym / sponsor ID
- RDL-13
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MCB group | Experimental | Procedure: mucosal cutting biopsyUse a disposable high-frequency cutting knife under endoscopy to cut open the surface mucosa of the tumor, and use biopsy forceps to extract tissue that can be fully evaluated for pathological examination. Use a disposable hemostatic clip to suture the mucosal incision, and after thorough observation of the hemostasis, withdraw from the endoscope. |
| EUS-FNA group | Active comparator | Procedure: endoscopic ultrasound-guided-fine needle aspirationUsing standard Endoscopic Ultrasonography-Guided Fine-Needle Aspiration(EUS-FNA) technology, using endoscopic ultrasound scanning to locate lesions, and puncture needle aspiration biopsy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Endoscopic evaluation considers gastric submucosal tumors (SMTs) with a diameter of ≥ 15mm
Key exclusion criteria (9 listed)
- Endoscopic non bulging lesions.
- The upper gastrointestinal lesions measured by Endoscopic Ultrasonography(EUS) are less than 15 mm.
- Lesions that do not require tissue collection (such as lipomas, varicose veins)
- Patients with cystic lesions
- The patient has uncorrectable coagulation dysfunction (International Normalized Ratio (INR)>1.5 or platelet count<50x109)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mucosal cutting biopsyUnder intravenous anesthesia, the patient inserted a gastroscopy (Olympus GIF-260J) through the mouth and used a disposable high-frequency cutting knife to cut open the surface mucosa of the tumor. Biopsy forceps were used to extract tissue that could be fully evaluated for pathological examination. Use a disposable hemostatic clip to suture the mucosal incision, and after thorough observation of the hemostasis, withdraw from the endoscope. ( | Procedure or surgery | MCB group |
| endoscopic ultrasound-guided-fine needle aspiration2) EUS-FNA group: Standard (Endoscopic Ultrasonography-Guided Fine-Needle Aspiration) EUS-FNA technology was used, and electronic linear array ultrasound endoscopy (GF-UCT-260, Olympus, Japan) was used to scan and locate the lesion. Puncture needle (Boston Scientific, USA) was used for aspiration biopsy. The thickness of the puncture needle depends on the size, hardness, and location of the tumor. | Procedure or surgery | EUS-FNA group |
Primary outcome
Pathological diagnosis and immunohistochemical diagnosis
Time frame: Pathological evaluation should be conducted immediately after specimen isolation
Comparison of diagnostic yield between Mucosal Cutting Biopsy (MCB) and Endoscopic Ultrasonography-Guided Fine-Needle Aspiration (EUS-FNA) The diagnostic yield was defined as the percentage of lesions confirmed by a pathologic diagnosis involving immunohistological analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Results publication: PubMed 32127736Dhaliwal A, Kolli S, Dhindsa BS, Devani K, Ramai D, Sayles H, Rangray R, Bhat I, Singh S, Adler DG. Clinical efficacy and safety of mucosal incision-assisted biopsy for the diagnosis of upper gastrointestinal subepithelial tumors: A systematic review and meta-analysis. Ann Gastroenterol. 2020 Mar-Apr;33(2):155-161. doi: 10.20524/aog.2020.0460. Epub 2020 Feb 14.
- Results publication: PubMed 20354939Fernandez-Esparrach G, Sendino O, Sole M, Pellise M, Colomo L, Pardo A, Martinez-Palli G, Arguello L, Bordas JM, Llach J, Gines A. Endoscopic ultrasound-guided fine-needle aspiration and trucut biopsy in the diagnosis of gastric stromal tumors: a randomized crossover study. Endoscopy. 2010 Apr;42(4):292-9. doi: 10.1055/s-0029-1244074. Epub 2010 Mar 30.
- Results publication: PubMed 32118100Sanaei O, Fernandez-Esparrach G, De La Serna-Higuera C, Carrara S, Kumbhari V, El Zein MH, Ismail A, Gines A, Sendino O, Montenegro A, Repici A, Rahal D, Brewer Gutierrez OI, Moran R, Yang J, Parsa N, Paiji C, Aghaie Meybodi M, Shin EJ, Lennon AM, Kalloo AN, Singh VK, Canto MI, Khashab MA. EUS-guided 22-gauge fine needle biopsy versus single-incision with needle knife for the diagnosis of upper gastrointestinal subepithelial lesions: a randomized controlled trial. Endosc Int Open. 2020 Mar;8(3):E266-E273. doi: 10.1055/a-1075-1900. Epub 2020 Feb 21.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Liming Zhang, M.D. study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mucosal cutting biopsy and endoscopic ultrasound-guided-fine needle aspiration in people with Gastrointestinal Stromal Tumor of Stomach and Submucosal Tumor of Stomach, run by Peking University People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Zhao, M.D. (8615611599955, zhaorui_001@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological diagnosis and immunohistochemical diagnosis (time frame: Pathological evaluation should be conducted immediately after specimen isolation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06748690, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.