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The subjects are randomly assigned to SurePath™/Conventional test group at a ratio of 1:1.

In SurePath™ group, subjects who underwent SurePath™ liquid-phase cytology test with the first sample subjected to the conventional smear test with the second sample.

The subjects are randomly assigned to SurePath™/Conventional test group at a ratio of 1:1.

In conventional test group, those who subjected to the conventional smear test with the first sample, will undergo the SurePath™ liquid cell test with the second obtained sample.

In the liquid-based cytology, a fine-needle aspirated sample is immediately inserted into a container containing a commercially available preservative solution without a separate slide-smearing procedure and immediately after the fine-needle aspiration.

SurePath™

Han Myung Lee, M.D.

Soo-Jeong Cho, M.D., Ph.D.

It is a prospective randomized controlled study to evaluate the diagnostic accuracy of SurePath™ liquid-based cytology in endoscopic ulatrasound-guided sampling.

The SurePath™ has been approved by the FDA since 1997. Investigators want to compare the diagnostic accuracy of SurePath™ liquid based cytology and conventional smear cytology(CSC) in EUS-FNA sampling of esophageal, gastric, duodenal subepithelial tumors, periesophageal and perigastric lymph nodes.

The investigators randomly assigned (1:1) patients to the SurePath™ group or the CSC group. Aspirates from the first needle pass were processed by one method, aspirates from the second pass by the other method, and specimens from the last pass were processed as core biopsy samples. The primary endpoint was the diagnostic efficacy of each method, with the final diagnosis as the gold standard. The aim of this study is to confirm that the SurePath™ is not inferior than the conventional smear test.

Diagnostic Accuracy of SurePath™ in EUS-FNA

A Prospective Comparison of SurePath™ Liquid -Based Cytology and Conventional Smear Cytology in Endoscopic Ultrasound-guided Sampling of Esophageal, Gastric, Duodenal Subepithelial Tumors, Periesophageal and Perigastric Lymph Nodes

Pathologic results of the surgical specimen or core needle biopsy will be checked whether it is malignancy or benign. If benign diagnosis is made by combining the results of SurePathTM and conventional smear test, the follow-up period is 6 months and the results of the 6-month follow-up imaging and additional biopsy are checked. The combined results make a final diagnosis and are compared between two groups.

We will evaluat the cytomorphologic features of each method. We plan to investigate whether there are differences in the level of artifacts, the degree of background cleanliness, and tumor cell characteristics such as cellularity.

Seoul National University Hospital

Clinical associate professor

Symptoms and General Pathology

Polyps

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Hormones

All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.

The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".

sodium alginate mixed with calcium lactate

Jui-Wen Kang

The aim of the investigators' study is to evaluate the mucosa-elevating capacity and clinical safety of Sodium Alginate (SA) mixed with Calcium Lactate in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection.

The study will evaluate the mucosa-elevating capacity and clinical safety of Gut Guarding Gel (the Sodium Alginate (SA) mixed with Calcium Lactate) in assisting Endoscopic Submucosal Dissection/Endoscopic Mucosal Resection to treat early gastroenterological tumor and polyps.

All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.

The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".

Determine the rates of the delayed bleeding/perforation, postpolypectomy electrocoagulation syndrome, and the late tissue injury.

Hydrogel Injection to Assist Endoscopic Submucosal Dissection

Gut Guarding Gel for Endoscopic Resection to Treat Early Gastroenterological Tumor and Polyps (Evaluation of the Safety of Sodium Alginate Mixed With Calcium Lactate on Endoscopic Mucosal Resection / Endoscopic Submucosal Dissection)

To evaluate patient's clinical symptoms and patient's complaints about the post-polypectomy electrocoagulation syndrome. The post-polypectomy electrocoagulation syndrome occurs after performing the endoscopy, and its signs and symptoms are similar to the signs and symptoms of perforation, such as severe abdominal pain and fever.

Perform the endoscopy to evaluate the delayed of bleeding/perforation after 4 weeks of hydrogel injection.

To keep follow up the patient's clinical symptoms to evaluate the delayed of bleeding/perforation after one month of hydrogel injection.

The Industrial Technology Research Institute

National Cheng Kung University

National Research Program for Biopharmaceuticals, Taiwan

National Cheng-Kung University Hospital

No adverse events occurred, such as fever, severe abdominal pain and delay-bleeding.

All participants in the study received Endoscopic submucosal dissection with Sodium Alginate mixed with Calcium Lactate prior to endoscopic resection.

Sodium alginate mixed with calcium lactate: The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as "Gut Guarding Gel".

Endoscopic Submucosal Dissection

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Taiwan

Region of Enrollment

Dr. Xi-Zhang Lin

Number of Patients With Postpolypectomy Electrocoagulation Syndrome

Number of Patients With Delayed Bleeding/Perforation

Number of Patients With Late Tissue Injury

Overall Study

Gland and Hormone Related Diseases

Rare Diseases

Pancreatic Neoplasms

Cholangiocarcinoma

Cysts

Pancreatic Diseases

Bile Duct Diseases

Pancreatic Cyst

Bile Duct Neoplasms

Biliary Tract Neoplasms

Biliary Tract Diseases

Adenocarcinoma

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pancreatic Cancer

Bile Duct Cancer

Standard echoendoscope will be used and EUS examination will be performed per standard of care.

EndoSound Vision System will be used and EUS examination will be performed per standard of care.

Endoscopic ultrasound examination will be performed.

Endoscopic ultrasound examination

Ji Young Bang, MD MPH

Barbara Broome

This is a randomized trial to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.

Endoscopic ultrasound (EUS) is the gold standard for evaluation and biopsy of lesions in the pancreaticobiliary tract, subepithelial lesions in the gastrointestinal tract and luminal cancer staging due to its high sensitivity and specificity. Endoscopic ultrasound examination is performed by echoendoscopes, which are endoscopes with an ultrasound probe at the distal end to allow endoscopic ultrasound evaluation. A new endoscopic ultrasound system - the EndoSound Visual System has now been developed for endoscopic ultrasound examination. The EndoSound Visual System is a device that can be attached externally to upper gastrointestinal endoscopes, thereby converting a standard endoscope into an echoendoscope which can then be used to perform an EUS examination.

The aim of this randomized trial is to compare the standard echoendoscope with the newly developed EndoSound Visual System in the evaluation of lesions in the gastrointestinal tract.

EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope

Randomized Trial of Endoscopic Ultrasound Examination Using EndoSound Vision System vs. Standard Echoendoscope

Rate of successful completion of the requisite examination during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, compared as a percentage of successfully completed examinations between the standard echoendoscope and Endosound Vision System.

The ease of maneuverability during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to maneuver and 5 is the most difficult to maneuver).

The quality of EUS imaging during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the best quality imaging and 5 is the worst quality imaging).

The ease of performing tissue acquisition during EUS between the EndoSound Vision System and standard echoendoscopes will be assessed, based on a rating scale of 1 to 5 (whereby 1 is the most easy to perform and 5 is the most difficult to perform).

Rate of diagnostic adequacy of procured tissue specimen on onsite evaluation between the EndoSound Vision System and standard echoendoscopes.

Rate of diagnostic adequacy of procured tissue specimen in cell block between the EndoSound Vision System and standard echoendoscopes.

Rate of diagnostic accuracy of procured tissue specimen between the EndoSound Vision System and standard echoendoscopes.

Duration of procedure between the EndoSound Vision System and standard echoendoscopes.

Rate of procedure-related adverse events between the EndoSound Vision System and standard echoendoscopes.

Costs associated with the endoscopic ultrasound procedures between the EndoSound Vision System and standard echoendoscopes.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Diagnostic Accuracy of SurePath™ in EUS-FNA	NCT05394129	Submucosal Tumo...	SurePath™	19 Years -	Seoul National University Hospital
Hydrogel Injection to Assist Endoscopic Submucosal Dissection	NCT03321396	Submucosal Tumo...	sodium alginate...	20 Years -	National Cheng-Kung University Hospital
EUS Examination Using EndoSound Vision System vs. Standard Echoendoscope	NCT06340620	Pancreatic Dise... Pancreatic Canc... Pancreatic Cyst Gastrointestina... Bile Duct Disea... Bile Duct Cance... Lymph Node Dise... Submucosal Tumo... Gastrointestina...	Endoscopic ultr...	18 Years - 100 Years	Orlando Health, Inc.
Diagnostic Accuracy of SurePath™ in EUS-FNA	NCT05394129	Submucosal Tumo...	SurePath™	19 Years -	Seoul National University Hospital
Hydrogel Injection to Assist Endoscopic Submucosal Dissection	NCT03321396	Submucosal Tumo...	sodium alginate...	20 Years -	National Cheng-Kung University Hospital

Spots Global Cancer Trial Database for submucosal tumor of gastrointestinal tract