Endoscopic Resection Techniques for Esophageal Cancer

(BEEPER Trial)

Recruiting at 1 trial location

Overseen By Thomas Rösch, Prof. Dr.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Universitätsklinikum Hamburg-Eppendorf

Must not be taking: Anticoagulants

Disqualifiers: Metastatic carcinoma, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 18 months

407 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{3 6 7 8 9}

How 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. ^{1 3 4 7 10}

Research Team

Thomas Rösch, Prof. Dr.

Principal Investigator

Ph D, Director, Head of department

Eligibility 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.

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.

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

Treatment Details

Interventions

• Endoscopic mucosal resection
• Endoscopic submucosal dissection

Trial Overview 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.

Participant Groups

Group I: EMR Active Control 1 Intervention

Endoscopic mucosal resection

Group II: ESD Active Control 1 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

Who Is Running the Clinical Trial?

Universitätsklinikum Hamburg-Eppendorf

Lead Sponsor

Trials

497

Recruited

2,984,000+

Findings from Research

Endoscopic mucosal resection (EMR) is effective for removing early gastrointestinal lesions under 20 mm with low risk of submucosal invasion, while endoscopic submucosal dissection (ESD) is recommended for larger or more complex lesions, particularly in the esophagus and stomach.

Both EMR and ESD can be tailored to individual patients based on lesion characteristics, with EMR being safe for smaller lesions and ESD providing curative options for larger lesions or those with submucosal invasion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EMR/ESD: Techniques, Complications, and Evidence. Ahmed, Y., Othman, M.[2021]

In a study of 780 early gastric cancer lesions, endoscopic submucosal dissection (ESD) showed a significantly lower local recurrence rate (0.2%) compared to endoscopic aspiration mucosectomy (EAM) (4.2%), indicating ESD's greater efficacy in long-term outcomes.

For lesions meeting specific criteria (JGCA and NCC), ESD demonstrated a local recurrence rate of 0%, while EAM had rates of 2.9% and 12.5% respectively, suggesting that ESD is a more effective treatment option for achieving radical curability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes of endoscopic submucosal dissection for early gastric cancer: a retrospective comparison with conventional endoscopic resection in a single center. Tanabe, S., Ishido, K., Higuchi, K., et al.[2022]

In a study of 85 patients with early esophageal adenocarcinoma, endoscopic submucosal dissection (ESD) demonstrated significantly higher rates of complete resection (100% en bloc resection) and curative outcomes (88% R0 resection) compared to endoscopic mucosal resection (EMR), which had only 39% and 21% respectively.

Both ESD and EMR showed similar long-term outcomes in terms of local recurrence (23% for ESD vs. 18% for EMR) and overall survival (89% for ESD vs. 86% for EMR), indicating that while ESD is more effective in achieving complete resection, it does not lead to better long-term survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic submucosal dissection versus endoscopic mucosal resection for early esophageal adenocarcinoma. Doumbe-Mandengue, P., Pellat, A., Belle, A., et al.[2023]

In a study of 132 patients with superficial esophageal squamous cell carcinoma, endoscopic submucosal dissection (ESD) showed a significantly higher curative resection rate (73.5%) compared to endoscopic mucosal resection (EMR) (21.3%), indicating ESD is more effective for this condition.

The 5-year recurrence-free survival rate was also better with ESD (95.2%) than with EMR (73.4%), suggesting that ESD should be the preferred treatment option for superficial esophageal SCC due to its superior long-term outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term follow-up after endoscopic resection for superficial esophageal squamous cell carcinoma: a multicenter Western study. Berger, A., Rahmi, G., Perrod, G., et al.[2020]

Endoscopic submucosal dissection (ESD) is more effective than endoscopic mucosal resection (EMR) for treating superficial esophageal cancer, showing higher rates of complete tumor removal and lower local recurrence rates based on a meta-analysis of eight studies.

While ESD has better efficacy outcomes, it is associated with longer operative times and a higher risk of perforation compared to EMR, indicating a trade-off between effectiveness and safety in treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic submucosal dissection vs endoscopic mucosal resection for superficial esophageal cancer. Guo, HM., Zhang, XQ., Chen, M., et al.[2022]

In a study of 129 patients with mucosal cancers undergoing EMR or ESD, only 2.3% had lymph node metastasis, suggesting that these procedures can be safe for certain early gastric cancers.

For submucosal cancers, 4% showed lymph node metastasis, indicating that while extended indications for EMR and ESD are possible, careful consideration is needed, especially for cancers that do not meet the criteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of extended endoscopic mucosal resection and endoscopic submucosal dissection following the Japanese Gastric Cancer Association treatment guidelines. Jee, YS., Hwang, SH., Rao, J., et al.[2022]

Endoscopic submucosal dissection (ESD) resulted in more complete resections (R0) and definitive diagnoses compared to endoscopic mucosal resection (EMR), with EMR showing higher rates of uncertain margins and equivocal pathology.

In a study of 51 cases (31 EMR and 20 ESD), the uncertainty in EMR led to more patients opting for elective esophagectomy, highlighting the potential clinical implications of choosing EMR over ESD for Barrett's-associated neoplastic lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic submucosal dissection is associated with less pathologic uncertainty than endoscopic mucosal resection in diagnosing and staging Barrett's-related neoplasia. Podboy, A., Kolahi, KS., Friedland, S., et al.[2021]

The novel gel used for submucosal injection during endoscopic procedures was found to be safe, as it did not cause any perforation, bleeding, or tissue damage in a study involving six Yorkshire pigs.

This gel provided a durable submucosal cushion that remained effective for at least four weeks, potentially improving the efficiency of endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) by minimizing complications and reducing procedure time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel gel provides durable submucosal cushion for endoscopic mucosal resection and endoscopic submucosal dissection. Chandrasekhara, V., Sigmon, JC., Surti, VC., et al.[2021]

Endoscopic mucosal resection (EMR) is effective for removing superficial gastrointestinal lesions, particularly those smaller than 2-3 cm, while larger lesions can be removed in pieces.

Endoscopic submucosal dissection (ESD) offers higher rates of complete (en-bloc) resections and lower recurrence rates compared to EMR, but it carries a higher risk of complications, especially in less experienced medical centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal endoscopic submucosal dissection is here to stay. Albéniz Arbizu, E., Enguita Germán, M.[2021]

Endoscopic submucosal dissection (ESD) and endoscopic mucosal resection (EMR) techniques have significantly reduced the need for surgery in early esophageal and gastric cancers, leading to lower morbidity and mortality rates.

ESD offers better en bloc resection rates for more aggressive early gastric cancers compared to EMR, but EMR is easier to learn and requires less time, making it valuable for early esophageal cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endoscopic resection of gastric and esophageal cancer. Balmadrid, B., Hwang, JH.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

EMR/ESD: Techniques, Complications, and Evidence. [2021]

2. Japan pubmed.ncbi.nlm.nih.gov

Long-term outcomes of endoscopic submucosal dissection for early gastric cancer: a retrospective comparison with conventional endoscopic resection in a single center. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Endoscopic submucosal dissection versus endoscopic mucosal resection for early esophageal adenocarcinoma. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Long-term follow-up after endoscopic resection for superficial esophageal squamous cell carcinoma: a multicenter Western study. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Endoscopic submucosal dissection vs endoscopic mucosal resection for superficial esophageal cancer. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Safety of extended endoscopic mucosal resection and endoscopic submucosal dissection following the Japanese Gastric Cancer Association treatment guidelines. [2022]

7. Australia pubmed.ncbi.nlm.nih.gov

Endoscopic submucosal dissection is associated with less pathologic uncertainty than endoscopic mucosal resection in diagnosing and staging Barrett's-related neoplasia. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

A novel gel provides durable submucosal cushion for endoscopic mucosal resection and endoscopic submucosal dissection. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

Colorectal endoscopic submucosal dissection is here to stay. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Endoscopic resection of gastric and esophageal cancer. [2022]