Neoplasms

All Conditions

Digestive System Diseases

Rare Diseases

Carcinoma

Carcinoma, Squamous Cell

Esophageal Neoplasms

Esophageal Squamous Cell Carcinoma

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Esophageal Diseases

Esophageal Cancer

Coagulants

All Drugs and Chemicals

Lugol's solution

* GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy
* Biopsy at the visually abnormal lesions
* Pathologic examination of all biopsy tissue specimens
* Advises of endoscopic/surgical or oncological treatment will be given to participants who will be diagnosed with ESCC or high grade dysplasia of the esophagus.

* GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy
* Biopsy at the unstained lesions \>= 5 mm diameter
* Pathologic examination of all biopsy tissue specimens
* Advises of endoscopic/surgical or oncological treatment will be given to participants who will be diagnosed with ESCC or high grade dysplasia of the esophagus.

GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions

NBI endoscopy

GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy Biopsy at the unstained lesions \>= 5 mm diameter Pathologic examination of all biopsy tissue specimens

Lugol chromoendoscopy

Jaroslaw Regula, PhD

Anna Chaber-Ciopinska, MD

This study evaluates the role of narrow band imaging (NBI) endoscopy compared with Lugol chromoendoscopy in the early detection of esophageal cancer in patients with prior head and neck cancers.

Patients with head and neck cancers have an increased risk for developing an esophageal squamous cell carcinoma (ESCC). Small, superficial, curable lesions are difficult to diagnose using only white light endoscopy. To improve detection chromoendoscopy is recommended. In this project patients are divided into two groups based on received chromoendoscopy (NBI versus Lugol). The results of two methods will be compare regarding positive predictive value to establish usage of chromoendoscopy in early detection of ESCC.

The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers

The Role of Narrow Band Imaging (NBI) Endoscopy Compared With Lugol Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers: a Prospective Randomized Study

The results of two methods are compare regarding positive predictive value.

Centre of Postgraduate Medical Education

Maria Sklodowska-Curie National Research Institute of Oncology

During the application stage of endoscopy, the patients are required to complete a RFQ according to their own situations. The RFQs will soon uploaded to the core server of the quality control system and be analysed automatically immediately after finish. The results are sorted into four types including "N/A", "High-risk for esophageal cancer", "High-risk for gastric cancer" and "High-risk for colorectal cancer", which will be shown during the endoscopy of the specific person.

The endoscopies are carried out by experienced endoscopists. All of the data of the endoscopy itself are collected and recorded in the quality control system.

The RFQ results of this group are not known (deliberately showing "N/A") by the endoscopists before and during the endoscopy.

During the application stage of endoscopy, the patients are required to complete a RFQ according to their own situations. The RFQs will soon uploaded to the core server of the quality control system and be analysed automatically immediately after finish. The results are sorted into four types including "N/A", "High-risk for esophageal cancer", "High-risk for gastric cancer" and "High-risk for colorectal cancer", which will be shown during the endoscopy of the specific person.

The endoscopies are carried out by experienced endoscopists. All of the data of the endoscopy itself are collected and recorded in the quality control system.

The RFQ results of this group are known by the endoscopists before and during the endoscopy.

The quality control system randomly shows the RFQ result to the endoscopists and keep 50% of the RFQ results are not known (deliberately showing "N/A") by the endoscopists before and during the endoscopy.

Result masking

Yanqing LI, Doctor

Zhen Li, Doctor

Yanqing Li, PhD. MD.

Despite improvements in a range of chemo, radio and surgical therapies, the overall survival at 5 years from gastrointestinal cancer remains poor. Endoscopic early diagnosis is a key strategy to improve survival but the detection rate of early cancer varies among different countries. Risk factor questionnaire result is easy to be obtained and may be of great help for improving the detection rate. The aim of this research is to validate a risk factor questionnaire to help predict gastrointestinal cancer therefore allowing earlier diagnosis and higher detection rate.

A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer

A Self-rating Risk Factor Questionnaire for the Improvement of Endoscopic Prediction of Gastrointestinal Cancer: a Big-data-based Diagnostic Study

The endoscopic detection rate change of precancerous lesions and early GI cancer with the help of self-rating RFQ for the prediction of GI cancer.

Yanqing Li

Professor

Barrett Esophagus

Precancerous Conditions

Oculocerebral Syndrome With Hypopigmentation

Conventional endoscopy followed by HRME+CVC after 30 days.

HRME+CVC followed by conventional endoscopy after 30 days.

High resolution magnification endoscopy with computed virtual chromoendoscopy and directed biopsy

HRME+CVC

Conventional white light endoscopy with four-quadrant biopsy

conventional endoscopy

Anders F Edebo, MD, PhD

The purpose of this study is to determine whether High Resolution Magnification Endoscopy (HRME) and Computed Virtual Chromoendoscopy (CVC) with targeted biopsies is superior to conventional white light endoscopy (WLE) with 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients with Barrett's Esophagus (BE).

BE is a metaplastic mucosal transformation adjacent to the esophagogastric junction, due to chronic reflux of gastric juices, Gastro Esophageal Reflux Disease (GERD). The continuous esophageal exposure of acid- and/or bile- containing fluids leads, untreated, to chronic esophagitis. In certain patients a mucosal transformation takes place. The epithelium in the distal part of esophagus is transferred from squamous into a more intestinal-like mucosa, called Specialized Intestinal Metaplasia (SIM).Patients with BE is believed to run a higher risk of developing esophageal adenocarcinoma (EAC).

EAC is a rare condition in the western society, but the prevalence is rising compared with other malignancies, and a substantial increase has been seen during the last four decades. The pathogenesis of cancer development is believed to be that SIM in some patients can undergo dysplastic transformation, from low to high grade, and from high grade dysplasia (HGD) develop into AC. Advanced EAC is associated to a poor prognosis whereas HGD or carcinoma in situ may be treated endoscopically with a favorable outcome.

The need for surveillance endoscopy in order to discover early cancer lesions available to curable treatment is up against cost effectiveness and evidence level regarding screening. The conventional endoscopic (CE) surveillance algorithm for BE is standard WLE and 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm above the esophagogastric junction. The development of advanced endoscopic techniques have made it possible to distinguish minimal polypoid lesions but also the microvasculature and pit-pattern structures that in certain grading systems have been associated to presence of dysplasia. Attempts have been made in exploring the benefits of advanced endoscopic technologies against standard WLE. Feasibility-studies suggests that the new techniques improves the biopsy-yield for dysplasia, however only a limited number of prospective studies exist.

Study aim: To determine whether HRME and CVC with targeted biopsies is superior to conventional WLE with 4 quadrant biopsies of the metaplastic epithelium every 1-2 cm (Seattle Protocol) for detection of pre-malignant lesions in patients with BE.

Primary endpoint: Incidence of detected dysplasia by each endoscopic technique. Secondary endpoints: 1.The yield of low- and/or high-grade dysplasia by each endoscopic technique. 2.The number of biopsies taken and the duration of the different endoscopic techniques. 3.The endoscopic prediction capability of present dysplasia compared to histopathology for HRME.

Statistical power: Based on the primary endpoint, the amount of dysplasia in a Barrett-population is approximately 10%. We calculated a raise in positive yield with using advanced endoscopy to 8%. At p\<0,05 and a power of 80% the need for 105 patients.

Setting: Tertiary referral high volume endoscopy center at Sahlgrenska University Hospital, Sweden.

Endoscopic Detection of Dysplasia in Barrett's Esophagus

High Resolution Magnifying Endoscopy and Contrast Enhanced Imaging Versus Standard White Light Endoscopy for the Detection of Dysplasia in Barrett's Esophagus. A Prospective Blinded Cross-over Study.

Sahlgrenska University Hospital, Sweden

Göteborg University

The group of patients who did endoscopies without sedation.

The group of patients who did endoscopies with sedation.

The group of patients who did endoscopies with or without sedation. (This is a choice of themselves)

Sedation

The influence of sedation on the endoscopic detection rate of the precancerous lesions and cancer of upper digestive system has not been assessed. In the daily medical routine of China, patients have the right to choose the sedation style according to his or her own situation, whose detailed endoscopic data of patients are recorded in the endoscopy quality control system. The aim of this research is to detect whether the use of sedation can help improve detection rate of precancerous lesions and cancer of upper digestive system.

Sedation Versus No Sedation for Detection Rates of Precancerous Lesions and Cancer

Sedation Versus No Sedation for Diagnostic Esophagogastroduodenoscopies and Detection Rates of Precancerous Lesions and Cancer: a Case-control Study

Detection rate of precancerous lesions and cancer of upper digestive system improvement

Weihai Municipal Hospital

Binzhou Medical University

Qilu Hospital of Shandong University (Qingdao)

Shandong University

Symptoms and General Pathology

Hemorrhage

Gastrointestinal Hemorrhage

Hemostatics

Patients treated with optimal clinical management, as it is been advised by the latest guidelines

Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards

Hemospray (Endoscopic treatment with hemostatic powder)

This study evaluates the efficacy of the endoscopic hemostatic powder for the treatment of bleeding from malignant lesions of the upper GI tract. Half of participants will receive hemostatic powder and half will be submitted to standard treatment.

Gastrointestinal tumor bleeding is a challenging clinical condition with a high mortality rate. Several endoscopic hemostasis techniques have been tested, but results were disappointing. Re-bleeding and mortality rates are still high.

Hemostatic powder is a promising therapy for tumor bleeding, since it can be applied over large surfaces. Bleeding from a tumor lesion often occurs diffusely on the surface of the tumor rather than from a specific vessel.

Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions

Randomized Controlled Trial of Hemostatic Powder Versus Optimal Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions

Instituto do Cancer do Estado de São Paulo

Stomach Neoplasms

Metaplasia

Stomach Diseases

Stomach Cancer

Anti-Infective Agents

Antineoplastic Agents

Micronutrients

Vitamins

Acetic Acid

Retinol acetate

Vitamin A

Retinol palmitate

Anti-Bacterial Agents

Adjuvants, Immunologic

Immunologic Factors

Protective Agents

Retinol

Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy

Acetic acid chromoendoscopy

Kyung Ho Song, M.D., Master

The presence and the extent of gastric intestinal metaplasia(IM) is a good indicator of high risk group of gastric cancer. Many methods was developed to survey it, including multiple gastric biopsy or methylene blue chromoendoscopy. But they are not practical in the routine screening exam, limited by cost and accessibility. Spraying of acetic acid is commonly used in screening cervical cancer, to induce whitish discoloration of metaplastic mucosa. The investigators have confirmed such whitish discoloration is induced in gastric IM, with accuracy \> 80% in a pilot study of the investigators. This prospective study will tell the accuracy, sensitivity and specificity of acetic acid chromoendoscopy for judging gastric IM.

Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia

Acetic Acid Chromoendoscopy for Judging Extent of Gastric Intestinal Metaplasia

Endoscopist judges the presence and the extent of gastric intestinal metaplasia during acetic acid chromoendoscopy. Endoscopist perform five endoscopic biopsies according to the protocol. The degree of agreement between the chromoendoscopy and the endoscopic biopsy is assessed as %.

The findings of chromoendoscopy will be interpretated by two endoscoipists (read as positive or negative finding) independently.

We calculate the Kappa index of agreement for the acetic acid chromoendoscopy.

Number of Participants with Adverse Events. Assess kind of side effect and severity. Measured by interview with a physician, just after the procedure and 1weak later.

Konyang University Hospital

Assistant Professor

Underwent acetic acid chromoendoscopy, with spraying 1.5% acetic acid, during screening gastroduodenoscopy.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Role of Chromoendoscopy in the Early Detection of Esophageal Cancer in Patients With Prior Head and Neck Cancers	NCT02435602	Esophageal Squa... Squamous Cell C...	NBI endoscopy Lugol chromoend...	18 Years -	Maria Sklodowska-Curie National Research Institute of Oncology
A Questionnaire for Endoscopic Prediction Improvement of Gastrointestinal Cancer	NCT04071431	Early Detection...	Result masking	18 Years -	Shandong University
Endoscopic Detection of Dysplasia in Barrett's Esophagus	NCT01694511	Barrett's Esoph...	HRME+CVC conventional en...	20 Years - 80 Years	Göteborg University
Sedation Versus No Sedation for Detection Rates of Precancerous Lesions and Cancer	NCT04069975	Early Detection...	Sedation	18 Years -	Shandong University
Hemostatic Powder Versus Clinical Management for the Treatment of Upper Gastrointestinal Bleeding From Tumor Lesions	NCT02820077	Gastrointestina... Gastrointestina...	Hemospray (Endo...	18 Years -	Instituto do Cancer do Estado de São Paulo
Acetic Acid Chromoendoscopy to Judge Gastric Intestinal Metaplasia	NCT01499576	Stomach Neoplas... Metaplasia	Acetic acid chr...	35 Years - 70 Years	Konyang University Hospital

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