Digestive System Diseases

All Conditions

Gastroesophageal Reflux

Non-Erosive Reflux Disease

All Drugs and Chemicals

Proton Pump Inhibitors

Patients who were diagnosed clinically as NERD and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were accessed.

Ilaprazole

Non-erosive reflux disease (NERD) patients used to be less responsive to proton pump inhibitor (PPI)s as compared with patients with erosive esophagitis. The aim of this study is to objectively evaluate the effect of a new PPI, ilaprazole in NERD for adjusting the focus of symptom score, histopathologic findings and inflammatory biomarker.

A prospective study performed at single hospital enrolled 20 patients who were diagnosed clinically as NERD. Patients underwent EGD, a 24hr-combined multichannel intraluminal impedance and pH esophageal monitoring (MII-pH) and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) will be accessed.

The Prospective Study on the Effect of Ilaprazole in Non-erosive Reflux Disease Patients; Focused on Histologic Findings and Inflammatory Biomarker

All patients complete the GerdQ questionnaire before and after taking ilaprazole. It was utilized to assess improvement of symptoms after taking medicine.

Changes of histopathological findings and inflammatory biomarkers will be assessed before and after treatment. Histologic findings include basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte. Inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were also accessed by RT-PCR.

Yonsei University

Wounds and Injuries

Surgical Wound

Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection.

Endoscopic band ligation without resection

To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife.

SINK

Joan B Gornals, MD, PhD

Francesc Bas-Cutrina, MD

To analyse the effectiveness and safety of endoscopic band ligation without resection in small gastrointestinal subepithelial tumours.

Multicenter prospective study analysing the effectiveness and safety of endoscopic band ligation without resection in small (≤15-mm) gastrointestinal subepithelial tumours.

This endoscopic technique will be complemented with a SINK (single-incision needle-knife) biopsy for ensuring the pathological diagnosis of the treated subepithelial tumour.

Banding Without Resection in Small Subepithelial Tumours

Effectiveness and Safety of the Endoscopic Band Ligation Without Resection of ≤15-mm Subepithelial Tumours of the Digestive Tract: a Multicenter Prospective Study

Complete removal and disappearance of the subepithelial tumour at 4-6 weeks by endoscopic ultrasonography control.

Complete removal and disappearance of the subepithelial tumour at 1 year by endoscopic ultrasonography control.

Incidence of treatment-emergent adverse events, graded by American Society of Gastrointestinal Endoscopy (ASGE) guideline (Ref: Cooton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, et al. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc 2010;71:446-54).

Positive definitve pathological result rate of single-incision needle-knife (SINK) biopsies permorfed in subeptihelial tumours ligated.

Recurrence of indeterminate or pre-malignant subepithelial tumours rate at 5 years by endoscopic ultrasonography control.

Joan B Gornals

Principal investigator

Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Endoscopic ultrasound (EUS)-guided fine needle biopsy (FNB)

EUS-FNB

Silvia Carrara, MD

Alessandro Repici, MD

Andrea Anderloni, MD

Milena Di Leo, MD

Roberta Maselli, MD

Alessandro Fugazza, MD

Alessia Galtieri, MD

Elisa Ferrara, MD

Gaia Pellegatta, MD

The differentiation among the Gastrointestinal Subepithelial Tumors (SETs) represents a clinical challenge. Endoscopic Ultrasound (EUS) alone may be ineffective in differentiating SETs subtypes, and tissue sampling of these lesions may be technically difficult. EUS Elastography (EUS-E) has been applied to many gastrointestinal diseases, providing a qualitative/semi-quantitative stiffness analysis, but only few studies have examined the role of EUS-E in the diagnosis of SETs. In addition, the use of contrast agents has improved the diagnostic performance of the EUS, especially in the differentiation between GISTs and other gastrointestinal SETs.

The aim of the study is to examine the performance of EUS-E and Contrast Enhanced-EUS (CE-EUS) in distinguishing among different gastrointestinal SETs subtypes. EUS patterns of different techniques will be compared to the final diagnosis gained by the analysis of histopatological specimens (surgical resection or EUS-FNB) or imaging/clinical follow-up.

EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors

EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors: a Multicenter Prospective Observational Study

Evaluation of EUS-E accuracy (qualitative and quantitative elastography) and contrast enhanced endoscopic ultrasound (CE-EUS) in the diagnosis of SETs.

Istituto Clinico Humanitas

Behaviors and Mental Disorders

Anxiety Disorders

Quality of Life

The subephitelial tumour is successfully removed by endoscopic band ligation without resection.

The subephitelial tumour is not successfully removed due to various reasons (size \>15-mm, not technical success,...).

The subephitelial tumour is not observed or is a benign entity, which does not require further interventions for these patients.

Answer to Hospital Anxiety and Depression Scale (HADS), Cancer Worry Scale (CWS) and European Five-Dimension Quality of Live test (EuroQol-5D) before the initial endoscopic procedure.

Initial Anxiety and Fear of Cancer Test

Correct application of the elastic band in the subepithelial tumor, achieving its removal by self-amputation in the 4-6 weeks endoscopic ultrasonography (EUS) control.

Endoscopic band ligation without resection of the subpetihelial tumour.

Answer to Hospital Anxiety and Depression Scale (HADS), Cancer Worry Scale (CWS) and European Five-Dimension Quality of Live test (EuroQol-5D) after 1-2 months of the initial endoscopic procedure, knowing whether the tumor has either been removed or not, is a benign entity or has not been observed.

1-2 Months Anxiety and Fear of Cancer Test

Answer to Hospital Anxiety and Depression Scale (HADS), Cancer Worry Scale (CWS) and European Five-Dimension Quality of Live test (EuroQol-5D) after 1 year of the initial endoscopic procedure, knowing whether the tumor has either been removed or not.

1 Year Anxiety and Fear of Cancer Test

Sebastià Videla, MD, PhD

To analyze the hypothetical improvement in anxiety degree, quality of life and fear of cancer in patients diagnosed with a small gastrointestinal subeptithelial tumor when opting for the removal of the lesion.

This "Quality of Life" study is directly related to the "BANDING-SET" study (NCT03247231), whose main aim is to analyze the effectiveness and safety of endoscopic band ligation without resection in the small gastrointestinal subepithelial tumours management.

Using three validated tests (Hospital Anxiety and Depression Scale \[HADS\], Cancer Worry Scale \[CWS\] and European Five-Dimension Quality of Live test \[EuroQol-5D\]) patients are evaluated before and after the endoscopic procedure.

Three main groups of patients are presented:

* GROUP A, in which the subephitelial tumour is successfully removed \[hypothesis: anxiety and fear of cancer should decrease\].
* GROUP B, in which the subephitelial tumour is not successfully removed due to various reasons (size \>15-mm, not technical success,...) \[hypothesis: anxiety and fear of cancer shuold be similar before-after\].
* GROUP C, in which the subephitelial tumour is not observed or is a benign entity, which does not require further interventions for these patients \[hypothesis: anxiety and fear of cancer should decrease\].

Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)

Anxiety, Fear of Cancer and Quality of Life Degree Before and After Endoscopic Band Ligation Without Resection in Subepithelial Tumours of the Digestive Tract ≤15-mm Management: a Multicenter Prospective Study

At 1-2 months, number of patients with a total anxiety score of 8 or more points in the Hospital Anxiety and Depression Scale (HADS), anxiety subescale.

Hospital Anxiety and Depression Scale (HADS), anxiety subescale, legend:

* 0-7 points: Normal.
* 8-10 points: Borderline anxiety.
* 11-21 points: Anxiety disorder.

At 1-2 months, number of patients with a total fear of cancer score of 11 or more points in the Cancer Worry Scale (CWS).

Cancer Worry Scale (CWS) legend:

* 6-10 points: Low.
* 11-15 points: Moderate.
* 16-20 points: High.
* 21-24 points: Very high.

At 1 year, number of patients with a total anxiety score of 8 or more points in the Hospital Anxiety and Depression Scale (HADS), anxiety subescale.

Hospital Anxiety and Depression Scale (HADS), anxiety subescale, legend:

* 0-7 points: Normal.
* 8-10 points: Borderline anxiety.
* 11-21 points: Anxiety disorder.

At 1 year, number of patients with a total fear of cancer score of 11 or more points in the Cancer Worry Scale (CWS).

Cancer Worry Scale (CWS) legend:

* 6-10 points: Low.
* 11-15 points: Moderate.
* 16-20 points: High.
* 21-24 points: Very high.

Francesc Bas-Cutrina

Principal Investigator

Device: 22G FNA needle

Device: 20G FNB needle

Background: Preoperative pathologic diagnosis of subepithelial tumor (SET) can improve clinical decision making. Although EUS-guided fine needle aspiration (FNA) is currently considered the standard method for sampling SET, its diagnostic yield is generally suboptimal. EUS-guided fine needle biopsy (FNB) of SET is safe and feasible with adequate histology obtained.

Objective: To compare the diagnostic accuracy of EUS-FNA and EUS-FNB.

EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors

Gold standard diagnosis is defined as;

1. in operated patients; histological assessment of the surgical resection specimen
2. in non-operated patients; based on the conclusions of the diagnostic work-up (combined outcomes of FNA and FNB samples and imaging studies)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Prospective Study on the Effect of Ilaprazole in Non-erosive Reflux Disease Patients; Focused on Histologic Findings and Inflammatory Biomarker	NCT02666976	Gastrointestina...	Ilaprazole	20 Years - 80 Years	Yonsei University
Banding Without Resection in Small Subepithelial Tumours	NCT03247231	Gastrointestina...	Endoscopic band... SINK	18 Years - 80 Years	Hospital Universitari de Bellvitge
EUS-Elastography and Contrast-Enhanced EUS Diagnostic Accuracy in the Differential Diagnosis of Subepithelial Gastrointestinal Tumors	NCT04695262	Gastrointestina...	EUS-FNB	18 Years - 85 Years	Istituto Clinico Humanitas
Anxiety and Fear of Cancer Before and After Banding Without Resection in Small SET Management (QUALI-BANDING-SET)	NCT04316000	Gastrointestina...	Initial Anxiety... Endoscopic band... 1-2 Months Anxi... 1 Year Anxiety ...	18 Years - 80 Years	Hospital Universitari de Bellvitge
EUS-guided Fine Needle Aspiration (EUS-FNA) Versus EUS-guided Fine Needle Biopsy (EUS-FNB) for Diagnosis of Subepithelial Tumors	NCT02943837	Gastrointestina...	Device: 22G FNA... Device: 20G FNB...	19 Years - 75 Years	Asan Medical Center

Spots Global Cancer Trial Database for gastrointestinal subepithelial tumors