Complete Resection of Barrett's Esophagus Harboring Neoplasia With Endoscopic Submucosal Dissection.

NCT05983419 | Unknown

• 2 other identifiers: KarolinskaUH 2021-014992021-01499
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Barretts Esophagus With Dysplasia

Keywords

ESD

Outcome Measures

Primary Outcomes (1)

• Safety for full resection in BE

  Adverse events are defined as any complication in which ESD or ESD related procedures (such as anesthesia) are a contributing factor and include bleeding, perforation, stricture and aspiration pneumonitis.

  From enrollment to the end of study at 6 months

Study Arms (1)

intervantion

EXPERIMENTAL

Complete resection of Barrett's esophagus harboring neoplasia with endoscopic submucosal dissection.

Procedure: ESD

Interventions

ESD PROCEDURE

Complete resection of Barrett's esophagus harboring neoplasia with endoscopic submucosal dissection.

intervantion

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of neoplastic Barrett's esophagus on previous biopsies confirmed by expert pathologist.

You may not qualify if:

• Presence of signs of deep submucosal invasion (\>sm1)
• Anticoagulation therapy that cannot be discontinued (ASA allowed)
• Barrett's esophagus length \> 9 cm (C and/or M)
• Immunosuppression that would contraindicate use of steroids.
• Diabetes Mellitus

Sponsors & Collaborators

• Francisco Baldaque-Silva: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, Sweden

RECRUITING

Related Publications (2)

• Pech O, Behrens A, May A, Nachbar L, Gossner L, Rabenstein T, Manner H, Guenter E, Huijsmans J, Vieth M, Stolte M, Ell C. Long-term results and risk factor analysis for recurrence after curative endoscopic therapy in 349 patients with high-grade intraepithelial neoplasia and mucosal adenocarcinoma in Barrett's oesophagus. Gut. 2008 Sep;57(9):1200-6. doi: 10.1136/gut.2007.142539. Epub 2008 May 6.

  PMID: 18460553 BACKGROUND

• Li N, Pasricha S, Bulsiewicz WJ, Pruitt RE, Komanduri S, Wolfsen HC, Chmielewski GW, Corbett FS, Chang KJ, Shaheen NJ. Effects of preceding endoscopic mucosal resection on the efficacy and safety of radiofrequency ablation for treatment of Barrett's esophagus: results from the United States Radiofrequency Ablation Registry. Dis Esophagus. 2016 Aug;29(6):537-43. doi: 10.1111/dote.12386. Epub 2015 Jun 30.

  PMID: 26121935 BACKGROUND

Central Study Contacts

Francisco Baldaque-Silva Baldaque-Silva, MD PhD

CONTACT

+46704997219; fbaldaquesilva@gmail.com

Masami Omae, MD

CONTACT

+46702578413; machami242000@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: August 9, 2023
• Study Start: August 1, 2023
• Primary Completion: August 1, 2025
• Study Completion: February 1, 2026
• Last Updated: August 9, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)