Active clinical trials for "Barrett Esophagus"

The study will compare EMR versus ESD technique (both combined with subsequent ablative therapy) of mucosal resection in Barrett's esophagus with regard to efficacy and risk in a long term setting.

The aim of the clinical trial is to evaluate the EndoRotor®'s ability to completely remove areas of Barrett's esophagus considered refractory after 3 failed ablation treatments (Radiofrequency Ablation (RFA) and/or Cryotherapy) or in patients with at least 1 failed ablative procedure (RFA and/or Cryotherapy) and are intolerant to the procedure due to pain, where intolerant is defined as post-dysphagia or odynophagia persisting for 24 hours or greater or requiring narcotic analgesia for a duration of more than 24 hours.

A multicenter, prospective, single arm, non randomized clinical trial to evaluate the safety and efficacy of the C2 CryoBalloon Focal Ablation System (CbFAS) for the treatment of persistent dysplasia or intestinal metaplasia (IM) in the tubular esophagus after 3 or more radiofrequency ablations (RFA) for dysplastic BE, or <50% eradication of Barrett's Esophagus (BE) after 2 RFA treatments.

This study compares patients' acceptability and safety of two established endoscopic methods for treating dysplastic Barrett's esophagus: radiofrequency ablation versus hybrid argon plasma coagulation.

Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem (CBAS180) at decremental doses for the treatment of dysplastic Barrett's epithelium.

Barrett Esophagus is a common pathology, with an estimated prevalence of 1.6% at risk of progression to precancerous mucosa (low to high grade dysplasia). The incidence of adenocarcinoma on BE is 0.5% per year. In the event of dysplasia or cancer in situ, it is currently recommended at international and particularly European level to eradicate BE. The treatment techniques used to date carry out thermal destruction of the BE, in particular by radiofrequency. Eradication of dysplasia is achieved in 81% to 100% and disappearance of BE in 73% to 87% of cases. It requires an average of 3 destruction sessions. RF does not allow histological analysis after destruction of BE, but the risk of progression to neoplasia is estimated at 7.8/1000 persons per year. This risk could be due to the presence of glands buried in the esophageal mucosa. Indeed, these glands are not destroyed by thermal ablation methods, and remain invisible during endoscopic controls. A new treatment technique using the Endorotor® system allows mechanical resection of the entire mucosa in one session of treatment. In addition, the cost of these thermal destruction techniques currently limits their wider diffusion. It is therefore legitimate to propose a less expensive and probably more effective alternative technique.

Patients with Barrett's esophagus (BE) have a change in the lining of the esophagus. The normal one the lining of the esophagus changes to a lining similar to that of the intestine. The new mucosa has increased the risk of developing cancer. Usually this type of cancer is detected in a late phase and the patients' survival is low (less than 25% at 5 years). In daily practice, we strive to detect early cancerous lesions in order to treat them and cure them the patients. It has been widely demonstrated in BE patients that if cancer or precursor lesions are detected in an early phase, patients can be cured with endoscopic treatment. Endoscopic treatment of BE is based on endoscopic resection of the lesions / early cancer. After resection, patients have a 20-47% risk of developing cancer later in the remaining Barrett's esophagus. So there is a need to remove the remaining Barrett's mucosa that has not been resected. Several techniques can be used for removal of remaining BE: radiofrequency ablation, argon plasma, cryotherapy or endoscopic resection. The goal is to after resection of cancer and removal of residual Barrett's mucosa, a normal esophageal epithelium will cover the esophagus and dramatically reduce the risk for cancer development. The most widely used strategy for removal of residual Barrett's mucosa is radiofrequency ablation. It is an easy technique to perform, but it is hindered by some factors: 1) it requires several treatment sessions; 2) is associated with complications in 11% of patients, such as severe pain, bleeding, stricture and perforation 3) Barrett's mucosal glands may grow under the new epithelium after treatment; 4) there is no histological assessment of what is ablated; 5) there is a need for continuous follow-up; 6) it there are high costs associated with this strategy; 7) This approach may cause physical and physiological burdens on patients due to continuous follow-up and lack of complete histological assessment. Endoscopic submucosal dissection (ESD) is an advanced endoscopic technique that enables resection of lesions or cancer in one piece and has been used extensively along the gastrointestinal tract. Studies have showed good effect of ESD for neoplastic BE. Karolinska has a lot of experience with ESD and has one of the largest the cohorts of ESD on BE patients. ESD of BE can be associated with complications such as bleeding and perforation in 2-3% in most published studies and in less than 1% each in our series. Another complication that can occur is narrowing of the the esophagus during the healing process after ESD. That risk was historically high and increased with the increase in the size of the resected specimen. The high risk of crowding out was the main inhibiting factor the development of ESD in the esophagus. With the introduction of steroid therapy to prevent narrowing a paradigm shift was formed and the corresponding narrowing risk was drastically reduced to between 2-33% in according to the size of the resections. In our series of 132 ESDs on Barrett's esophagus, 103 cases corresponded resections up to 75% of the luminal(?) circumference of the esophagus, in these only 4/103 (3.9%) had strictures and all were successfully treated with endoscopic balloon dilatation. In the remaining 29 ESDs: included resection more than 75% of the luminal circumference. In these, there was narrowing in 10/29 cases, all patients was successfully treated with endoscopic treatment. So preventive measures and thorough follow-up are associated with good results and safety profile, even in large ESD on BE. Several years ago did not perform ESD for the treatment of BE, due to the need for skilled endoscopists and the potential the risks of this procedure such as bleeding, perforation and strictures. Full resection of the BE mucosa allows complete resection of all mucosa at risk, with complete histological assessment and virtually no risk of lesion presence in the margins or development of buried glands. It leads to complete removal of BE and may lead to the need for additional follow-up. With this study, we want to test the efficacy and safety of ESD for the removal of all Barrett's mucosa, instead of the more common approach of resection of Barrett's cancer followed by ablation of the remaining BE.

Aim of this prospective multicenter study is to evaluate the safety of an endoscopic follow-up strategy in patients treated with endoscopic resection (ER) for submucosal or high-risk mucosal esophageal adenocarcinoma (T1bN0M0 or HR T1aN0M0 EAC).

The investigators hypothesize that detection of field cancerization in the GI tract could be performed during endoscopy by performing Raman and scattering measurements. Together with the Technical University of Munich (TUM) and the Universidad Carlos III de Madrid (UC3M), the investigators have developed an investigational medical device that integrates probe-based Raman and scattering measurements for endoscopic purposes: the SENSITIVE system. During preclinical ex vivo studies, the investigators have established that measurements of the SENSITIVE system were able to discriminate between non-field cancerized tissue and field cancerized tissue. Considering these results, the investigators aim to assess the safety of in vivo Raman/scattering during endoscopy. Secondly, the investigators to assess the feasibility of this approach measurements to determine field cancerization in the alimentary tract during endoscopy through the SENSITIVE system.

This prospective cohort study aims to assess the utility of a panel of molecular biomarkers for predicting the risk of relapse of Barrett's Oesophagus after endoscopic treatment of early oesophageal neoplasia with RadioFrequency Ablation (RFA). Patients who received endoscopic treatment of early oesophageal neoplasia with RFA and achieved endoscopic remission will be recruited. During the surveillance visits patients will receive a Cytosponge test followed by an endoscopy with Narrow Band Imaging (NBI) magnification and biopsies. Patients will receive an endoscopy every 6 months and Cytosponge every 12 months for at least 2 years. Molecular biomarkers including a methylation panel on DNA and immunohistochemical markers on formalin fixed paraffin embedded samples. After 2 years of intensive endoscopic follow up, patients will be prospectively tracked for up to 3 years. The investigators will also evaluate: The risk of progression to dysplasia or oesophageal intestinal metaplasia (IM) in patients with IM at the GOJ post RFA in the absence of retreatment the diagnostic accuracy of NBI for IM/dysplasia at the GOJ .