Neoplasms

Digestive System Diseases

All Conditions

Rare Diseases

Esophageal Neoplasms

Stomach Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Stomach Diseases

Head and Neck Neoplasms

Esophageal Diseases

Esophageal Cancer

Stomach Cancer

Michael H. Larsen, M.D.

Michael H Larsen, M.D.

Michael B. Mortensen, M.D., Phd

Endoscopic submucosal dissection (ESD) is a relatively new modality for the treatment of superficial gastrointestinal neoplasia and especially in the diagnosis and treatment of submucosal tumors. ESD has become a minimal invasive alternative to surgery but requires a high degree of endoscopic skills to be performed safely, it is time consuming, and less safe than endoscopic mucosa resection.

New endoscopic instruments have been developed to increase the efficacy and safety of ESD, and a combined endoscopic instrument (HybridKnife) has been developed and evaluated with promising results in animal studies. This HybridKnife allows high-pressure water-jet (submucosal) dissection, as well as cutting and coagulation and makes ESD possible without changing instrument.

The purpose of this study is to evaluate the feasibility and safety of using HybridKnife for ESD in humans.

Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife

Odense University Hospital

Michael Bau Mortensen

Ear, Nose, and Throat Diseases

Mouth and Tooth Diseases

Deglutition Disorders

Barrett Esophagus

Precancerous Conditions

Pharyngeal Diseases

Otorhinolaryngologic Diseases

CSA System (CryoSpray AblationTM System)

CryoSpray Ablation

Bruce D Greenwald, M.D.

The purpose of this study is to confirm the effectiveness and safety of a new medical device which sprays liquid nitrogen through an upper endoscope (cryotherapy) to treat Barrett's esophagus with high-grade dysplasia and early esophageal cancer. It is hypothesized that this treatment will remove the abnormal lining of the esophagus and allow the normal esophageal lining to return.

Barrett's esophagus (BE) with high grade dysplasia (HGD) is a precursor of esophageal adenocarcinoma. Eliminating this condition may control the current rapid rise of adenocarcinoma. Ablative techniques are attempted to avoid the high morbidity and mortality of esophagectomy or for use in patients who cannot undergo surgery. Current ablative techniques have achieved mucosal ablation with variable success but are associated with high cost, patient discomfort and/or significant complications. A novel device which sprays liquid nitrogen through an upper endoscope (cryotherapy) has been shown to be a safe and effective procedure to ablate the esophageal mucosa in swine and dog models and in pilot studies in humans. Successful reversal of BE, LGD, HGD and superficial adenocarcinoma and squamous cell carcinoma have been demonstrated when cryotherapy with this device is followed by healing of the esophageal lining in a low acid environment.

This study is undertaken to demonstrate the efficacy and safety in the ablation of Barrett's esophagus with high-grade, neoplasia, and severe esophageal squamous dysplasia and to confirm preliminary results in humans.

Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer

Cryotherapy Ablation of Barrett's Esophagus and Early Esophageal Cancer

HGD or inoperable intramucosal or submucosal carcinoma and severe squamous dysplasia: measure of reduction in size of HGD or carcinoma

HGD or inoperable intramucosal carcinoma: Rate of complete ablation of all BE and associated HGD or intramucosal carcinoma

Number of treatment sessions needed to ablate BE and associated HGD or intramucosal carcinoma

Inoperable mucosal or submucosal carcinoma (T1mN0, T1smN0 and T2N0): Time to cancer recurrence

Inoperable severe squamous dysplasia: Rate of complete ablation of all dysplasia

Number of treatment sessions needed to ablate dysplasia

CSA Medical, Inc.

University of Maryland, Baltimore

Pharmaceutical Solutions

All Drugs and Chemicals

Micronutrients

Anti-Infective Agents

Coagulants

Iodine

Lugol's solution

Cadexomer iodine

Add pronase 20000 U in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.

No pronase in 80ml pretreatment mixture plus 5ml Dimethicone and 1g sodium bicarbonate.

use pronase to improve visibility during endoscopical iodine staining

Pronase

No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining

Control

Kaichun Wu, Ph.D. & M.D.

Lugol's solution staining was regarded as a gold standard to detect early superficial lesion during esophageal cancer screening using endoscopy. However, the sensitivity and specificity were influenced by mucus and food debris of esophagus. Pronase, a kind of protease, was previously shown to improve the visibility of gastrointestinal tract. It's unknown if the pre-treatment with pronase would also improve the quality of iodine staining in esophagus.A randomized double-blind clinical trial was designed to investigate whether or not pronase might improve detection rate of early esophageal lesion, especially high grade dysplasia and early cancer by improving the esophageal visibility.

Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer

Detection Rate=（lesions with confirmed high grade dysplasia/all iodine void lesions）\*100%

Beijing Tide Pharmaceutical Co., Ltd

Xijing Hospital of Digestive Diseases

Associate Professor

Symptoms and General Pathology

Colonic Polyps

Polyps

Intestinal Polyps

Pathological Conditions, Anatomical

Muhammer Ergenç, MD

The aim of the study is retrospectively evaluating all features of endoscopic and pathological diagnoses of cases who underwent upper and lower gastrointestinal endoscopy.

Gastrointestinal system endoscopy has an important place in the diagnosis and treatment of many diseases related to this system and provides an alternative to current surgical methods with its ever-expanding field of application. Upper and lower gastrointestinal endoscopy procedures are performed with many indications, such as new complaints in the gastrointestinal tract at the age of 50 and over, family history of gastrointestinal malignancy. In addition, the importance of endoscopy is gradually increasing as tissue and cell samples can be taken for histopathological studies and endoscopic treatment of some diseases.

The aim of the study is to review patients' indications, distribution by age and gender, frequency of lesions diagnosed on endoscopy, prevalence, size, histology and location of polyps detected and excised, results of endoscopic and pathological diagnoses.

The study population consists of the patients who were examined at the Istanbul Sultanbeyli State Hospital Endoscopy Unit between 01.01.2016 and 01.01.2021.

The patients' data will be scanned retrospectively by accessing their files from the computer database.

Retrospective Review of Gastrointestinal System Endoscopy Procedures

Age distribution of patients in endoscopic procedures and histopathological examinations

Sex distribution of patients in endoscopic procedures and histopathological examinations

Number of each endoscopy, Type (esophagogastroduodenoscopy, colonoscopy, rectosigmoidoscopy)

Number of endoscopic indications, Type (Abnormal imaging, GI bleeding, Anemia, Screening and surveillance, Diarrhea, Constipation, Abdominal pain, Weight loss, Dyspepsia, Heartburn, Dysphagia, Odynophagia, Upper belly pain or chest pain that is not heart-related, Intractable vomiting, Bleeding in the upper, Persistent gastroesophageal reflux symptoms, Occult gastrointestinal bleeding, Other)

The patients with complications / the total patients

Number of adverse events; early or late (within 1 month), related to the endoscopic procedure, Type (cardiopulmonary complication, gastrointestinal bleeding, perforation, mortality)

The patients with benign gastrointestinal disease / the total patients

The patients with malign gastrointestinal disease / the total patients

The patients with polyp / the total number of screening endoscopy patients

The patients with tumor / the total number of screening endoscopy patients

The patients with polyp / the total number of symptomatic patients endoscopy

The patients with tumor / the total number of symptomatic patients endoscopy

The patients with polyp / the total patients

Number of polyp localizations, Type (Rectum, Sigmoid colon, Descending colon, Splenic flexure, Transverse colon, Hepatic flexure, Ascending colon, Caecum, Multiple localization)

The patients with non-neoplastic biopsy results / the total patients

The patients with gastric disease / the total patients

The patients with bowel disease / the total patients

The patients with advanced neoplasia / the total patients

The patients with gastric cancer / the total patients

The patients with colorectal cancer / the total patients

The number of completed procedures / total number of procedures

Istanbul Sultanbeyli State Hospital

General Surgeon

Colorectal Neoplasms

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Wu kaichun, PhD

According to the latest global cancer epidemiological data published by the International Agency for Research on Cancer, colorectal cancer (CRC) ranks 3rd in total incidence and 2nd in total mortality among all malignancies worldwide. The prognosis of CRC is directly related to tumor stage. The 5-year survival rate for early CRC can reach 90%, while less than 14% for advanced CRC. Therefore, early diagnosis of CRC is particularly important. Gastrointestinal (GI) endoscopy is an important method in the diagnosis of CRC. Currently, diagnosis of GI endoscopy is mainly based on morphological changes of tumors, while early-stage tumors are difficult to be detected because of the indistinguishable morphology. Studies have shown that the molecular function of cancer cells can be altered in early-stage tumors. The development of a new endoscopic system that can identify early tumor molecular function changes and improve the accuracy of morphological diagnosis will greatly improve the early diagnosis rate of CRC, which is the future direction of GI endoscopic system design and development.

The combination of high-definition white light endoscopy, endoscopic cerenkov luminescence imaging (ECLI) and probe-based confocal laser endomicroscopy (pCLE) is ideal for future new GI endoscopy. High-definition white light endoscopy is helpful to quickly find and locate suspected abnormal mucosa; on top of this, ECLI enables molecule-specific functional imaging for accurate identification and determination of GI lesions; and further relies on pCLE for high-precision "cellular-level" lesion images for optical biopsy of lesions. Through the multimodal digestive endoscopy, structural imaging and functional imaging can be accomplished simultaneously, playing the innate advantage of multimodal information fusion diagnosis and facilitating the identification of early-stage tumors.

In this clinical trial, twenty patients with colorectal cancer who underwent PET-CT in Xijing Hospital were enrolled. Multimodal digestive endoscopy, combination of high-definition white light endoscopy, ECLI and pCLE, was used to perform for each patient's rectal cancer. ECLI images were compared with PET-CT images, and pCLE images were compared with tumor histopathology, which evaluate the actual imaging effect of multimodal digestive endoscopy in human.

Clinical Validation of Multimodal Digestive Endoscopy

Clinical Validation of Multimodal Digestive Endoscopy in Colorectal Cancer Diagnosis

Multimodal digestive endoscopy, combination of high-definition white light endoscopy, ECLI and pCLE, was used to perform for each patient's rectal cancer in order to acquire tumor images.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife	NCT01185483	Endoscopy, Dige... Esophageal Neop... Stomach Neoplas...		18 Years - 85 Years	Odense University Hospital
Study of Cryotherapy Treatment of Barrett's Esophagus and Early Esophageal Cancer	NCT00321958	Barrett Esophag... Esophageal Neop... Deglutition Dis... GERD Neoplasm	CSA System (Cry... CryoSpray Ablat...	18 Years -	University of Maryland, Baltimore
Endoscopic Submucosal Dissection in Upper Gastrointestinal Canal With HybridKnife	NCT01185483	Endoscopy, Dige... Esophageal Neop... Stomach Neoplas...		18 Years - 85 Years	Odense University Hospital
Pronase Improves Efficacy of Chromoendoscopy Screening on Esophageal Cancer	NCT02030769	Esophageal Neop...	Pronase Control	18 Years - 75 Years	Xijing Hospital of Digestive Diseases
Retrospective Review of Gastrointestinal System Endoscopy Procedures	NCT05012527	Endoscopy Colonoscopy Gastroscopy Colonic Polyps Endoscopy, Dige... Gastrointestina... Biopsy		18 Years - 100 Years	Istanbul Sultanbeyli State Hospital
Clinical Validation of Multimodal Digestive Endoscopy	NCT05575765	Colorectal Neop... Confocal Laser ... Molecular Imagi... Endoscopy, Dige...		18 Years - 80 Years	Xijing Hospital of Digestive Diseases

Spots Global Cancer Trial Database for endoscopy, digestive system