Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Stomach Cancer

Dermatologic Agents

All Drugs and Chemicals

Menthol

20 mL NPO-11 in a prefilled plastic syringe

The placebo is included same additives as active comparator.

Placebo

Patients with early gastric cancer, who require therapeutic upper gastrointestinal endoscopy, such as endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD), will receive intragastric spraying of NPO-11 or placebo. The superiority of NPO-11 to placebo as anti-peristaltic agent will be verified in a randomized, double-blind, parallel-assignment design 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 in comparison with the placebo group.

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

Phase III Placebo-controlled Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy (Randomized, Double-blind, Parallel-assignment, Placebo-controlled Study)

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

Nihon Pharmaceutical Co., Ltd

Symptoms and General Pathology

Atrophy

Gastritis, Atrophic

Metaplasia

Precancerous Conditions

Gastritis

Pathological Conditions, Anatomical

Gastroenteritis

Upper gastrointestinal endoscopy every year (12-16 months)

Upper gastrointestinal endoscopy every three years (32-40 months)

In all patient's complete gastroscopy first with White light and then with virtual chromoendoscopy will be made;

* Suspicious lesions with dysplasia/cancer will be biopsied 1-2 fragments in a different vial; if an irregular area of mucosa (pattern C) with no clearly defined lesion then 1-2 guided biopsies fragments will be taken and sent in a different vial;
* EGGIM (Endoscopic Grading of Gastric Intestinal Metaplasia) will be calculated according to previous description of this classification:
* If EGGIM 0 (no endoscopically apparent IM) biopsies will be made in antrum, incisura and corpus according to Sydney-Houston protocol;
* If EGGIM 1 or more guided biopsies of suspicious areas of IM should be made replacing the random biopsies in that particular area;
* Antrum, incisura and corpus fragments should be sent in 3 separate vials;

Upper gastrointestinal endoscopy

Pedro Pimentel-Nunes, MD PhD

Diogo Libanio, MD PhD

Pedro Nunes, MD PhD

Introduction: Gastric atrophy and intestinal metaplasia are the principal precursors for gastric cancer and, therefore, are considered gastric premalignant conditions. Although current guidelines recommend surveillance of individuals with these conditions, the best method for its identification and staging (histological vs endoscopy) and the best time schedule for follow-up are still controversial. Aims: To describe for the first-time patients with premalignant conditions both clinically (familial history), histologically (OLGA/OLGIM; complete/incomplete metaplasia) and endoscopically (EGGIM) using validated scales and to describe evolution of these parameters through time. To estimate prospectively the gastric cancer risk according to EGGIM stages. To define the best endoscopic surveillance follow-up for the several stages considering clinical, histological and endoscopic factors.

Methods: Multicenter study involving different gastroenterology departments from several countries. Consecutive patients older than 45 years scheduled for upper endoscopy in each of these centers will be evaluated by High-Resolution- endoscopy with virtual chromoendoscopy and EGGIM will be calculated. Guided biopsies (if areas suspicious of IM) and/or random biopsies (if no areas suspicious of IM) in antrum and corpus will be made and OLGA/OLGIM stages calculated. Patients will be evaluated in clinical consultation and database will be fulfilled. All patients will be eradicated for Helicobacter pylori infection if positive. At that occasion, all the patients with EGGIM\>5 and/or OLGA III/IV and/or OLGIM III/IV will be randomized for yearly (12 to 16 months) or every three years (32-40 months) endoscopic follow-up during a period of 6 years (SUPREME I). Endoscopic observational follow-up will be scheduled for patients with EGGIM 1-4 and OLGIM I/II at 3 and 6 years (SUPREME II). For individuals with no evidence of IM (EGGIM 0 and OLGIM 0, OLGA 0-II) a follow-up endoscopy 6 years after will be proposed (SUPREME III).

Introduction: Gastric atrophy and intestinal metaplasia are the principal precursors for gastric cancer and, therefore, are considered gastric premalignant conditions. Although current guidelines recommend surveillance of individuals with these conditions, the best method for its identification and staging (histological vs endoscopy) and the best time schedule for follow-up are still controversial. Aims: To describe for the first-time patients with premalignant conditions both clinically (familial history), histologically (OLGA/OLGIM; complete/incomplete metaplasia) and endoscopically (EGGIM) using validated scales and to describe evolution of these parameters through time. To estimate prospectively the gastric cancer risk according to EGGIM stages. To define the best endoscopic surveillance follow-up for the several stages considering clinical, histological and endoscopic factors.

Methods: Multicenter study involving different gastroenterology departments from several countries. Consecutive patients older than 45 years scheduled for upper endoscopy in each of these centers will be evaluated by High-Resolution-endoscopy with virtual chromoendoscopy and EGGIM will be calculated. Guided biopsies (if areas suspicious of IM) and/or random biopsies (if no areas suspicious of IM) in antrum and corpus will be made and OLGA/OLGIM stages calculated. Patients will be evaluated in clinical consultation and database will be fulfilled. All patients will be eradicated for Helicobacter pylori infection if positive. At that occasion, all the patients with EGGIM\>5 and/or OLGA III/IV and/or OLGIM III/IV will be randomized for yearly (12 to 16 months) or every three years (32-40 months) endoscopic follow-up during a period of 6 years (SUPREME I). Endoscopic observational follow-up will be scheduled for patients with EGGIM 1-4 and OLGIM I/II at 3 and 6 years (SUPREME II). For individuals with no evidence of IM (EGGIM 0 and OLGIM 0, OLGA 0-II) a follow-up endoscopy 6 years after will be proposed (SUPREME III).

Patients with EGGIM \> 5 or OLGA/OLGIM III/IV (premalignant stomach group - SUPREME I) will be randomized to endoscopic surveillance every one (12 to 16 months) or three years (32-40 months);

SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up

Proportion of patients with dysplasia (low or high-grade)

Proportion of patients with gastric adenocarcinoma

Proportion of patients with intramucosal carcinoma with low-risk criteria ("curative" criteria)

Proportion of patients with submucosal, diffuse type or intramucosal carcinoma with high-risk criteria ("non-curative" criteria)

Proportion of patients with advanced gastric cancer (without indication for endoscopic treatment)

Instituto Portugues de Oncologia, Francisco Gentil, Porto

Principal Investigator

Ulcer

Peptic Ulcer

Esophagitis

Esophageal Neoplasms

Esophageal Diseases

Duodenal Diseases

Intestinal Diseases

Head and Neck Neoplasms

Esophageal Cancer

patients underwent upper gastrointestinal endoscopy with sedation

patients underwent upper gastrointestinal endoscopy without sedation

Diansan Su, Doctor

Xiangrui Wang, Doctor

Xiaoqing Zhang, M.S.

lizhi Li, M.S.

Lizhi Li, M.S.

The primary objective is to investigate the adverse events during upper gastrointestinal endoscopy with and without sedation in Chinese population

Adverse Events During Upper Gastrointestinal Endoscopy

Adverse Events During Upper Gastrointestinal Endoscopy With and Without Sedation: a Multiple Center Report From Shanghai

Investigate the adverse events according to the Adverse event reporting tool of the world SIVA International Sedation Task Force during upper gastrointestinal endoscopy with and without sedation.

Shanghai Pudong New Area People's Hospital

Shanghai Tongji Hospital, Tongji University School of Medicine

RenJi Hospital

Hypoxia

Signs and Symptoms, Respiratory

Oxygen(2L/min) supplied with nasal catheter

Oxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator

Oxygen supplied through WEI NASAL JET with a manual jet ventilator

Oxygen is supplied through WEI NASAL JET by a manual jet ventilator

WEI NASAL JET

Oxygen is supplied directly through WEI NASAL JET without jet ventilator

Nasopharyngeal airway without jet ventilator

Diansan Su, Dr.

Yi Qin, Master

Low pulse oximetry is the most common adverse events during sedation for upper gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be evaluated.

WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

Safety and Efficacy Evaluation of The Nasopharyngeal Airway Embedded With Jet Ventilation Catheter(WEI NASAL JET) Applied for The Sedation of Outpatient Upper Gastrointestinal Endoscopy

The adverse events according to the Adverse event reporting tool of the world SIVA International Sedation Task Force during upper gastrointestinal endoscopy will be recorded. Adverse events associated with jet ventilation also be recorded.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Phase III Study of NPO-11 in Patients Undergoing Therapeutic Upper Gastrointestinal Endoscopy	NCT01411176	Gastric Cancer	Menthol Placebo	20 Years -	Nihon Pharmaceutical Co., Ltd
SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up	NCT04613570	Atrophic Gastri... Intestinal Meta... Gastric Dysplas... Gastric Cancer	Upper gastroint...	45 Years -	Instituto Portugues de Oncologia, Francisco Gentil, Porto
Adverse Events During Upper Gastrointestinal Endoscopy	NCT01979549	Patients Need U... Peptic Ulcer Gastric Cancer Esophagus Cance... Oesophagitis		18 Years -	RenJi Hospital
SUrveillance of PREMalignant Stomach - Individualized Endoscopic Follow-up	NCT04613570	Atrophic Gastri... Intestinal Meta... Gastric Dysplas... Gastric Cancer	Upper gastroint...	45 Years -	Instituto Portugues de Oncologia, Francisco Gentil, Porto
WEI NASAL JET for The Sedation of Outpatient Upper Gastrointestinal Endoscopy	NCT02436018	Peptic Ulcer Gastric Cancer Esophagus Cance... Oesophagitis Hypoxia	WEI NASAL JET Nasopharyngeal ...	18 Years -	RenJi Hospital
Adverse Events During Upper Gastrointestinal Endoscopy	NCT01979549	Patients Need U... Peptic Ulcer Gastric Cancer Esophagus Cance... Oesophagitis		18 Years -	RenJi Hospital

Spots Global Cancer Trial Database for upper gastrointestinal endoscopy