Infections

All Conditions

Symptoms and General Pathology

Neoplasms

Digestive System Diseases

Rare Diseases

Communicable Diseases

Stomach Neoplasms

Atrophy

Adenoma

Gastritis, Atrophic

Metaplasia

Gastritis

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Pathological Conditions, Anatomical

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Gastroenteritis

Stomach Cancer

Subjects without Helicobacter pylori infection and without atrophy

Subjects with Helicobacter pylori infection and without atrophy

Subjects with Helicobacter pylori infection and with atrophy

Subjects without Helicobacter pylori infection and with atrophy

Sun-Young Lee, MD

Serum pepsinogen (PG) levels are considered reliable markers for progression of atrophic gastritis with a stepwise reduction in the serum PG I level or PG I/II ratio. A combination of serum PG levels and Helicobacter pylori serology are used as a biomarker strategy for detection of individuals at increased risk of gastric neoplasm based on Correa's hypothesis. The investigators aimed to uncover whether this combination method could predict the risk of gastric neoplasms and the progression of chronic atrophic gastritis after 3 years. All the participants will be followed for an expected average of 3 years.

According to the Correa's hypothesis, the combination method using serum pepsinogen levels and serum Helicobacter pylori antibody would predict the risk and cell type of gastric neoplasm. However, in endemic regions of H. pylori infection such as in East Asian countries (Korea, Japan, and China), most of the aged population are have current or had past H. pylori infection. Therefore, in this study, we are going to uncover whether the risk of gastric neoplasm is significantly higher in the atrophy(+)/H. pylori(-) group followed by atrophy(+)/H. pylori(+), atrophy(-)/H. pylori(+), and atrophy(-)/H. pylori(-) groups. In addition, we are going to investigate whether those slow-growing gastric neoplasms such as differentiated gastric cancers with Lauren's intestinal type and gastric adenoma are more commonly developed in atrophy group following the Correa's hypothesis, whereas rapid-growing gastric neoplasms such as poorly-cohesive carcinoma or undifferentiated gastric cancers with Lauren's diffuse type are more commonly developed in the subjects without atrophy. Taken as a whole, our study result will provide an evidence whether this biomarker strategy are useful for the detection of individuals at increased risk of gastric neoplasm.

Serum for Helicobacter pylori antibody and pepsinogen levels Gastric biopsy for the diagnosis of intestinal metaplasia, atrophy, inflammatory cells, Helicobacter pylori, and the presence of gastric neoplasm if any.

Long-term Follow-up Prognosis of Atrophic Gastritis After 3 Years

Significance of Helicobacter Pylori Infection and Pepsinogen Levels on the Prognosis of Atrophic Gastritis - Observational Study

Presence of Helicobacter pylori infection

Degree of gastric atrophy measured by serum pepsinogen I and II levels

Konkuk University Medical Center

Associate professor

Coagulants

All Drugs and Chemicals

Dermatologic Agents

Hemostatics

Menthol

Patients who require therapeutic upper gastrointestinal endoscopy, such as polypectomy, endoscopic hemostasis, percutaneous endoscopic gastrostomy (PEG), endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive an intragastric spraying of NPO-11. The efficacy of NPO-11 as an anti-peristaltic agent for the endoscopic therapeutic procedures will be evaluated based on the proportion of patients with suppressed gastric peristalsis during the procedures. The degree of gastric peristalsis is assessed by an independent committee.

The safety of NPO-11 will be evaluated based on adverse events and adverse drug reactions (ADRs) observed between administration and seven days after administration.

Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy

No or mild gastric peristalsis is defined as when patients have no or suppressed gastric peristalsis during the therapeutic procedure (for 45 s). The degree of gastric peristalsis in the time periods is assessed by an independent committee.

Nihon Pharmaceutical Co., Ltd

A system consisting of a magnifying endoscope combined with narrow-band imaging (NBI), with the spectral band width narrowed by optical filters, was developed to enhance visualization of mucosal surface structure and vascular architecture. There were some reports that the magnifying endoscopy with narrow band imaging (ME-NBI) is superior to predict the histologic differentiation, depth of invasion and lesion margin than WLE.

magnifying endoscopy with narrow band imaging (ME-NBI)

Jun Chul Park

The treatment of early gastric cancer can be divided into endoscopic resection and surgery, and the precise staging of early gastric cancer is very important to prevent unnecessary surgery or additional surgery after the procedure. The possibility of endoscopic resection is determined by the risk of lymph node metastasis. The risk factors of lymph node metastasis of early gastric cancer are lesion size, presence of ulceration, histologic differentiation, and depth of invasion. In contrast to other factors, the factor of invasion depth is relatively difficult to predict by using the conventional white light endoscopy (WLE). Therefore, the endoscopic ultrasonography (EUS) has been tried to use for prediction of the invasion depth. However, many studies reported that the accuracy of endoscopic ultrasonography for predicting the depth of invasion was varied.

A system consisting of a magnifying endoscope combined with narrow-band imaging (NBI), with the spectral band width narrowed by optical filters, was developed to enhance visualization of mucosal surface structure and vascular architecture. There were some reports that the magnifying endoscopy with narrow band imaging (ME-NBI) is superior to predict the histologic differentiation, depth of invasion and lesion margin than WLE.

In this study, we divide the patients with suspected early gastric cancer (EGC) into the two groups as group using conventional WLE and EUS and group using WLE and ME-NBI, and try to compare the accuracy of EUS and ME-NBI for predicting the invasion depth of EGC. We also try to analyze the factors that affect the accuracy for predicting of depth such as characteristics of cancer lesion and histologic differentiation of cancer in each group. In addition, we try to analyze the characteristic imaging findings of ME-NBI for early gastric cancer and gastric adenoma and evaluate the efficacy of ME-NBI for early gastric cancer and gastric adenoma diagnosis.

The subjects is divided into early gastric cancer patients and gastric adenoma patients according to histologic biopsy result and white light endoscopic findings. Study 1 applies for early gastric cancer patients, Study 2 applies for gastric adenoma patients.

A) Study 1 The NBI group performs ME-NBI first before EUS. The endoscopist evaluates NBI findings such as the invasion depth and describes ME-NBI impression. And then, EUS is performed likewise. The final treatment plan is determined by the EUS result, so group assignment does not affect the final treatment plan.

The EUS group performs EUS first before NBI. The endoscopist evaluates EUS findings such as the invasion depth and describes EUS impression. And then, ME-NBI is performed likewise. The final treatment plan is determined by the EUS result, so group assignment does not affect the final treatment plan.

According to clinical stage of early gastric cancer, endoscopic resection is performed in case of endoscopic resection indication or beyond indication but case of having the risk of surgery according to patient status. The surgical resection is performed if the patient wants surgery or does not meet the indications of endoscopic resection.

The pathologist performs a histological evaluation of the resected gastric cancer lesion, including an invasive depth.

B) Study 2 First, the endoscopist performs WLE and describes WLE findings and impression such as location, size, and gross morphology of lesion. The same examiner performs ME-NBI and describes ME-NBI findings and impression such as mucosal pattern, predicted degree of dysplasia.

Endoscopic resection or surgical resection is performed according to the results of histologic result of gastric adenoma.

The pathologist performs a histological evaluation of the resected dysplastic lesion.

Magnifying Endoscopy With Narrow Band Imaging Versus Endoscopic Ultrasonography for Prediction of Tumor Invasion Depth in Early Gastric Cancer: A Prospective Comparative Study

The information related to this study will be used purely for research purposes and all data will be encrypted and strictly kept confidential and protected. In order to protect the personal information of the patient, information about the patient's identity and information about the patient will be managed as independent data.

To compare the accuracy of EUS and ME-NBI in predicting the invasion depth of EGC using final pathology result.

The characteristic imaging findings of ME-NBI for early gastric cancer and gastric adenoma such as microvessels, pits, histological patterns.

For example) ME-NBI classification Type A : clear regular surface patterns and microvascular architecture. Type B : obscure irregular surface patterns or microvascular architecture. Type C :no surface pattern and sparse microvessels or with avascular areas. Finally, to evaluate the efficacy of ME-NBI for early gastric cancer and gastric adenoma diagnosis.

Yonsei University

Hyuk Lee, Professor

Ji Eun Na, Doctor

Hyuk Lee, Pf.

Jieun Na, Dr.

Because advanced gastric cancer shows poor prognosis, it is important to detect early gastric cancer or precancerous gastric adenoma patients who have a cure rate of 95% or more. Moreover, a large part of early gastric cancer can be completely resected by endoscopic resection, thus ensuring a very high quality of life for patients. However, there are currently no markers that can be used for diagnosis of early gastric cancer or gastric adenoma. In addition, the biggest problem after endoscopic resection of early gastric cancer is metachronous recurrence of the cancer, which requires repeated endoscopic resection or additional surgical gastrectomy. However, there are no discovered markers for prediction of recurrence.

Liquid biopsy is a method of obtaining body fluids such as gastric juice or effusion through an endoscopic inlet during gastroscopy or colonoscopy and blood. Based on the advanced analysis method, liquid biopsy reveals more genetic information than tissue biopsy. Therefore, it is highly likely to become an essential factor in future personalized medicine. Therefore, this study was designed to identify whether tumor's molercular profiling based on tissue or blood could be used for prediction of prognosis and diagnosis of early gastric cancer and precancerous gastric adenoma.

1. Acquisition of tumor samples : Tissue and 10ml of blood will be collected for genomic examination of those histologically diagnosed with early gastric cancer or precancerous gastric adenoma lesion, and additional tissue and blood will be collected at 2 months, 1 year after treatment, and recurrence.
2. Suitability of tmor samples

   : Tumor areas (\> 60%) are dissected under microscopy from 4-μm-thick unstained sections by comparison with an H\&E stained slide, and genomic DNA was extracted using a Qiagen DNA FFPE Tissue Kit (Qiagen, Hilden, Germany) according to the manufacturer's instructions. After extraction, we measured concentrations and 260/280 and 260/230 nm ratios using a spectrophotometer (ND1000, Nanodrop Technologies, ThermoFisher Scientific, MA, USA). Each sample was then quantified with an Qubit fluorometer (Life Technologies, Carlsbad, CA, USA). Samples of genomic DNA with more than 10 ng measured by the Qubit fluorometer were subjected to AmpliSeq library preparation. To identify "druggable" CNVs, we used a 21-gene nCounter CNV assay.
3. Method of tumor molecular profiling

   * Ion Torrent PGM Amplieq Cancer Panel 2.0 : We use the Ion AmpliSep Cancer Panel V2(Ion Torrent) to detect frequent somatic mutations that were selected based on literature review. It examines 285 mutations in 50 commonly mutated oncogenes and tumor supressor genes. First, 10ng of DNA from each 89 FFPE tumor samples underwent single-tube, multiplex PCR amplication using the Ion AmpliSepCancer Primer Pool and the AmpliSepKit reagents (Life Technologies).Treatment of the resulting amplicons with FuPa Preagent partially digest the primers and phosphorylate the amplicons. The phosphorylate the amplicons are ligated to Ion dapters and purfied. For barcoded library preparation, we substitite barcoded adapters from the Ion XpressTM Library Kit. The ligated DNA undergose nick translation and amplication to complete the linkage between adapters and amplicons and to generate sufficient material for dowmstream template treparation. Two rounds of Agencourt® AMPure® XP Reagent binding at 0.6 and 1.2 bead- to- sample volum ratios removed input DNA and unincorporated primers form the amplicons. The final library molecules are 125-300bp in size. We then transfer the libries to the Ion OneTouchTM system for automated template preparation. Sequencing is performed on the Ion PGMTM sequencer according to the manufacturer's instructions. We use IonTorrent Software for automated data analysis.
   * nCounter copy Number Variation CodeSets : We custom designed a 21-gene CNV assay as outlined in a previous study. The 21 genes included AURAKA, CCND1, CCNE1, CDK4, CDK6, CDNK1A, CDNK2A, EGFR, ERBB2, ERBB3, FGFR1, FGFR2, IGFR1R, KLF5, KRAS, MDM2, MET, MITF, MYC, PIK3CA, and TNIK. For detection of CNVs, nCounter Copy Number Variation CodeSets were used with 200 ng purified genomic DNA. DNA was fragmented via AluI digestion and denatured at 95°C. Fragmented DNA was hybridized with the codeset of 21 genes in the nCounter Cancer CN Assay Kit (Nanostring Technologies) for 18 h at 65°C and processed according to the manufacturer's instructions. The nCounter Digital Analyzer counted and tabulated the signals of reporter probes. Quantified data were analyzed using NanoString's nSolver Analysis Software.
   * Immunohistochemistry

     : RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases)
   * Cancer Scan

     : targeted deep sequencing at Samsung Genome Institute

     : Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing
   * ASFA™ Spotter
4. Statistics : Analysis of genetic research is primarily technical. Data are presented using summary statistics tables and graphs. The total disease-free survival period is calculated by the Kaplan-Meier method through medical records of subjects who have undergone endoscopic resection.

Tissue and blood will be collected as follows from patients with early gastric cancer or precancerous gastric adenoma that satisfy the inclusion and exclusion criteria. Tissue will be collected through biopsy/endoscopic removal peformed prior to participation in this study. Biopsies will not be performed simply for research purposes. If a biopsy is performed during the follow-up process after treatment, relevant samples will be stored if an appropriate amount of the sample remains after the biopsy.

Clinical Application of Genetic Sequencing of Early Gastric Cancer and Gastric Adenoma Patients

Clinical Sequencing Project for Early Gastric Cancer and Precancerous Gastric Adenoma Patients for Personalized Cancer Clinic

Tumor's moleular profiling is assessed by following method:

1. Ion Torrent PGM Amplieq Canccer Panel 2.0
2. Nanostring copy number variation (CNV) panel
3. Immunohistochemistry: RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases)
4. Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing
5. ASFA™ Spotter

Comparison of tumor's molecular profile between the cases of recurrence and non-recurrence.

Tumor's moleular profiling is assessed by following method:

1. Ion Torrent PGM Amplieq Canccer Panel 2.0
2. Nanostring copy number variation (CNV) panel
3. Immunohistochemistry: RET, ATM, PD-L1, FGFR2, MLH, EGFR, ALK, ROS, TRKA. MET, HER2, PTEN loss (EGFR,CCNEI in selected cases)
4. Illumina HiSeq2000/2500-based, MiSeq NGS targeted sequencing
5. ASFA™ Spotter

The method of tumor's moleular profiling is same as the above.

Samsung Medical Center

Adjuvants, Anesthesia

Central Nervous System Depressants

Psychotropic Drugs

Analgesics

Midazolam

Meperidine

bispectral index monitoring

Jae.J Kim, professor

Ki Joo Kang, Dr

JaeJ Kim, professor

Background: Endoscopic submucosal dissection (ESD) usually requires adequate level of sedation due to lengthy and uncomfortable procedure. Propofol induced sedation with bispectral index (BIS) monitoring has been reported to lead to higher satisfaction of patients and endoscopists during ESD. However, there is no data about efficacy of midazolam and meperidine induced sedation with BIS monitoring during ESD. This study was to evaluate whether midazolam and meperidine induced sedation with BIS monitoring could improve the satisfaction and reduce the dose of midazolam and meperidine during ESD.

Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection

Samsung Medical Center IRB

Hemorrhage

Bone Density Conservation Agents

Calcium

Thrombin

Calcium, Dietary

Fibrin Tissue Adhesive

Aprotinin

Spread Fibrin glue(Greenplast Q™) at iatrogenic ulcer after gastric ESD

Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD

Human fibrinogen concentrate

Eunwoo Lee, M.D.

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

It is a prospective randomized controlled study to look for effectiveness of fibrin glue to prevent bleeding in high-risk patients after endoscopic submucosal dissection in gastric neoplasm.

Investigators want to observe the bleeding rate after endoscopic submucosal dissection for gastric tumors in the high-risk group of bleeding (the size of the iatrogenic ulcer is expected to be 40mm or more, or taking aspirin, antiplatelet drugs, and anticoagulants).

After resection and hemostasis with ESD, Fibrin glue (Greenplast Q™) is applied to the iatrogenic ulcer at the end of the procedure, and the control group will not be applied.

After that, observe whether there is a difference in the bleeding rate within 48 hours and 4 weeks.

Fibrin Glue After ESD for High Risk Patients of Bleeding

Effectiveness of Fibrin Glue to Prevent Bleeding in High-risk Patients After Endoscopic Submucosal Dissection in Gastric Neoplasm : A Prospective Randomized Controlled Study

Number of gastrointestinal bleeding events within 4 weeks after the procedure

Number of gastrointestinal bleeding events within 48 hours after the procedure

Number of gastrointestinal bleeding events from 48 hours to 4 weeks after the procedure

Seoul National University Bundang Hospital

Severance Hospital

Asan Medical Center

Seoul National University Hospital

Clinical associate professor

Ulcer

Gastrointestinal Hemorrhage

Gastrointestinal Agents

Rabeprazole

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

Ilaprazole tab 10mg, 2 tablets once daily for 8 weeks.

Rabeprazole tab 20mg, 1 tablet once daily for 8 weeks.

Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast

Ilaprazole

Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast

ChangSeok Bang, MD, PhD

This study compared Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and investigated Prevention of gastrointestinal bleeding.

This study is a Multicenter, Randomized, Parallel and Prospective study to compare Ulcer healing rate of Ilaprazole 20mg or Rabeprazole 20mg in the patients undergone Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer and to investigate Prevention of gastrointestinal bleeding.

Participants are defined as persons who underwent a Endoscopic Submucosal Dissection for Gastric Adenoma or Early Gastric Cancer. For 8 weeks, Participants treated as Ilaprazole 20mg or Rabeprazole 20mg once a day. After treatment, The ulcer healing rate was evaluated by Endoscopy at 4, 8 weeks.

Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.

Effects of Ilaprazole 20mg on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone Endoscopic Submucosal Dissection(ESD) for Gastric Adenoma or Early Gastric Cancer.

The rate of Ulcer size reduction(Δ) : \[(Initial ulcer size) - (Ulcer size at 8 weeks)\] / (Initial ulcer size)

Apply 0.15% Indigo carmine to scarring of the ulcer and Describe the pattern of the scar as flat, nodular or intermediate at tracking endoscopy.

The Korean Gastrointestinal Symptom Rating Scale questionnaire measured the patient's symptom degree.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-term Follow-up Prognosis of Atrophic Gastritis After 3 Years	NCT01824953	Gastric Neoplas... Gastric Cancer Gastric Adenoma Gastric Atrophy Intestinal Meta...		18 Years - 90 Years	Konkuk University Medical Center
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy	NCT01411189	Gastric Cancer Colon Nos Polyp... Gastric Adenoma	Menthol	20 Years -	Nihon Pharmaceutical Co., Ltd
Magnifying Endoscopy With Narrow Band Imaging Versus Endoscopic Ultrasonography for Prediction of Tumor Invasion Depth in Early Gastric Cancer: A Prospective Comparative Study	NCT03546257	Early Gastric C... Gastric Adenoma Gastric Dysplas...	magnifying endo...	19 Years -	Yonsei University
Clinical Application of Genetic Sequencing of Early Gastric Cancer and Gastric Adenoma Patients	NCT04665687	Early Gastric C... Gastric Adenoma		19 Years - 100 Years	Samsung Medical Center
Efficacy of Bispectral Index Monitoring for Midazolam and Meperidine Induced Sedation During Endoscopic Submucosal Dissection	NCT01157598	Gastric Adenoma Gastric Cancer	bispectral inde...	19 Years - 80 Years	Samsung Medical Center
Fibrin Glue After ESD for High Risk Patients of Bleeding	NCT04602689	Early Gastric C... Gastric Adenoma	Human fibrinoge...	19 Years - 84 Years	Seoul National University Hospital
Phase III Open-labeled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy	NCT01411189	Gastric Cancer Colon Nos Polyp... Gastric Adenoma	Menthol	20 Years -	Nihon Pharmaceutical Co., Ltd
Effects of Ilaprazole on Ulcer Healing Rate and Prevention of Gastrointestinal Bleeding in the Patients Undergone ESD.	NCT02638584	Gastric Cancer	Ilaprazole Rabeprazole	19 Years - 85 Years	Il-Yang Pharm. Co., Ltd.
Fibrin Glue After ESD for High Risk Patients of Bleeding	NCT04602689	Early Gastric C... Gastric Adenoma	Human fibrinoge...	19 Years - 84 Years	Seoul National University Hospital

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