Endoscopic Resection Techniques for Esophageal Cancer
(BEEPER Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byThomas Rösch, Prof. Dr.
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Universitätsklinikum Hamburg-Eppendorf
Must not be taking: Anticoagulants
Disqualifiers: Metastatic carcinoma, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but if you are on anticoagulants (blood thinners), you may need to stop them as they can make biopsies and resections impossible.
What data supports the effectiveness of the treatment Endoscopic mucosal resection (EMR) and Endoscopic submucosal dissection (ESD) for esophageal cancer?
Research shows that both EMR and ESD are effective first-line treatments for early esophageal cancer, including adenocarcinoma and squamous cell carcinoma. Studies comparing these techniques indicate that they are successful in removing early-stage cancerous tissues from the esophagus.
12345Is endoscopic resection safe for esophageal cancer?
Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are generally safe procedures for removing superficial lesions in the esophagus, but ESD may have a higher risk of complications, especially in less experienced centers.
36789How does the treatment of endoscopic resection techniques for esophageal cancer differ from other treatments?
Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are unique because they allow for the removal of early esophageal cancer without the need for traditional surgery, reducing recovery time and complications. ESD is particularly effective for deeper lesions, offering better complete removal rates, while EMR is quicker and easier to perform, making it a valuable option for early-stage cancers.
134710Eligibility Criteria
This trial is for patients with Barrett's esophagus needing mucosal resection and follow-up therapy, with lesions up to 10 cm. Participants must be able to comply with treatment and provide consent. It excludes those with serious illnesses, metastatic cancer, large or deep lesions, extensive Barrett's esophagus over 10 cm, or requiring more than two-thirds of the esophageal circumference resected.Inclusion Criteria
Patient's ability for compliance to therapy
Signed Informed Consent
I am scheduled for treatment on my esophagus using resection and ablation.
+1 more
Exclusion Criteria
American Society of Anesthesiologists (ASA) status > III
Pregnancy and lactation
I have a lesion that may not be removable by mucosectomy due to its size or depth.
+7 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) followed by ablative therapy
18 months
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up endoscopies and histological assessments
51 months
Participant Groups
The study compares two techniques for removing abnormal tissue in Barrett's esophagus: Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD), both followed by ablative therapy. The goal is to evaluate their long-term effectiveness and safety.
2Treatment groups
Active Control
Group I: EMRActive Control1 Intervention
Endoscopic mucosal resection
Group II: ESDActive Control1 Intervention
Endoscopic submucosal dissection
Endoscopic mucosal resection is already approved in United States, European Union, Japan for the following indications:
🇺🇸 Approved in United States as Endoscopic mucosal resection for:
- Barrett's esophagus
- Early-stage esophageal cancer
- Gastric cancer
- Colon cancer
🇪🇺 Approved in European Union as Endoscopic mucosal resection for:
- Barrett's esophagus
- Early-stage esophageal cancer
- Gastric cancer
- Colon cancer
🇯🇵 Approved in Japan as Endoscopic mucosal resection for:
- Early gastric cancer
- Barrett's esophagus
- Esophageal cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Orlando HealthOrlando, FL
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Who Is Running the Clinical Trial?
Universitätsklinikum Hamburg-EppendorfLead Sponsor
References
EMR/ESD: Techniques, Complications, and Evidence. [2021]To discuss endoscopic resection techniques of early gastrointestinal malignancy. The review will focus on the indications and outcomes of endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD).
Long-term outcomes of endoscopic submucosal dissection for early gastric cancer: a retrospective comparison with conventional endoscopic resection in a single center. [2022]Few studies have compared the outcomes of endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) in patients with early gastric cancer.
Endoscopic submucosal dissection versus endoscopic mucosal resection for early esophageal adenocarcinoma. [2023]Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) allow endoscopic resection of early esophageal adenocarcinoma. The choice between the two techniques takes into account the morphology of the lesion, and the experience of the endoscopist. The aim of this study was to compare EMR to ESD for the treatment of early esophageal adenocarcinoma.
Long-term follow-up after endoscopic resection for superficial esophageal squamous cell carcinoma: a multicenter Western study. [2020]Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are the first-line treatments for superficial esophageal squamous cell carcinoma (SCC). This study aimed to compare long-term clinical outcome and oncological clearance between EMR and ESD for the treatment of superficial esophageal SCC.
Endoscopic submucosal dissection vs endoscopic mucosal resection for superficial esophageal cancer. [2022]To investigate the effectiveness of endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) in treating superficial esophageal cancer (SEC).
Safety of extended endoscopic mucosal resection and endoscopic submucosal dissection following the Japanese Gastric Cancer Association treatment guidelines. [2022]Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) are widely performed. Indications for these procedures have been extended in Korea and Japan. The aim was to evaluate whether these extended indications are safe.
Endoscopic submucosal dissection is associated with less pathologic uncertainty than endoscopic mucosal resection in diagnosing and staging Barrett's-related neoplasia. [2021]Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) have demonstrated similar efficacy in removal of neoplastic esophageal lesions. However, significant controversy exists over the preferred resection technique. Our primary aim was to compare the pathologic specimens produced via EMR and ESD and secondarily gauge their effect on clinical decision making and patient outcomes.
A novel gel provides durable submucosal cushion for endoscopic mucosal resection and endoscopic submucosal dissection. [2021]Endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) have transformed the ability to endoscopically remove superficial lesions throughout the gastrointestinal tract. The purpose of this study was to determine the properties and safety of a novel gel designed for the purpose of submucosal injection for EMR and ESD.
Colorectal endoscopic submucosal dissection is here to stay. [2021]Endoscopic mucosal resection (EMR) or mucosectomy and endoscopic submucosal dissection (ESD) are both techniques that have modified the therapeutic outlook of superficial gastrointestinal tract lesions and neoplasms. EMR is used for the en-bloc excision of lesions smaller than 2-3 cm or the piecemeal resection of larger ones. In theory, ESD achieves higher rates of en-bloc resections as compared to EMR with a lower rate of recurrence; however, it shows a higher percentage of complications, particularly in inexperienced centers or in centers at the start of their learning curve.
Endoscopic resection of gastric and esophageal cancer. [2022]Endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) techniques have reduced the need for surgery in early esophageal and gastric cancers and thus has lessened morbidity and mortality in these diseases. ESD is a relatively new technique in western countries and requires rigorous training to reproduce the proficiency of Asian countries, such as Korea and Japan, which have very high complete (en bloc) resection rates and low complication rates. EMR plays a valuable role in early esophageal cancers. ESD has shown better en bloc resection rates but it is easier to master and maintain proficiency in EMR; it also requires less procedural time. For early esophageal adenocarcinoma arising from Barrett's, ESD and EMR techniques are usually combined with other ablative modalities, the most common being radiofrequency ablation because it has the largest dataset to prove its success. The EMR techniques have been used with some success in early gastric cancers but ESD is currently preferred for most of these lesions. ESD has the added advantage of resecting into the submucosa and thus allowing for endoscopic resection of more aggressive (deeper) early gastric cancer.