Endoscopic Resection Techniques for Esophageal Cancer

(BEEPER Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests two techniques, Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD), to remove abnormal tissue in the esophagus. It focuses on their effectiveness and safety over time. The trial targets individuals with Barrett's esophagus, a condition where the esophageal lining changes, who require tissue removal and further treatment. Suitable candidates have Barrett's esophagus extending up to 10 cm and can adhere to the treatment plan. As an unphased trial, it allows patients to contribute to medical knowledge and potentially benefit from advanced techniques.

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 prior data suggests that these endoscopic resection techniques are safe for esophageal cancer?

Research has shown that endoscopic mucosal resection (EMR) is generally safe for treating early esophageal cancer. This less invasive procedure helps preserve the esophagus. However, studies indicate a chance of cancer recurrence in the same area, necessitating regular check-ups after treatment.

Research also suggests that endoscopic submucosal dissection (ESD) is safe and effective, particularly for older patients with esophageal cancer. ESD often removes the cancer in one piece, reducing the likelihood of recurrence. Overall, both EMR and ESD are well-tolerated, but ESD may slightly better reduce the risk of cancer returning. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about endoscopic resection techniques for esophageal cancer because they offer a less invasive alternative to traditional surgery. Unlike standard surgical procedures that require large incisions, endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD) allow doctors to remove cancerous tissues through the mouth using specialized tools. This means less pain, quicker recovery times, and a lower risk of complications for patients. These techniques also enable precise targeting of cancerous areas, which can improve treatment outcomes and preserve healthy surrounding tissue.

What evidence suggests that this trial's treatments could be effective for esophageal cancer?

This trial will compare two endoscopic resection techniques for esophageal cancer: endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). Research has shown that both EMR and ESD effectively treat Barrett's esophagus with cancer. Studies have found that ESD often removes the tumor in one piece more effectively than EMR, ensuring no cancer cells remain. ESD can achieve up to 100% success in removing the tumor in one piece and has a complete removal rate of 82.3% or higher. EMR also yields good results, with some patients experiencing a five-year survival rate of about 85%. Both treatments are viable options, but ESD might be more effective for larger or more complex tumors. ^{2 3 5 6 7}

Who Is on the Research Team?

Thomas Rösch, Prof. Dr.

Principal Investigator

Ph D, Director, Head of department

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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]

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 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34845554/

Long-term outcomes of endoscopic mucosal resection for ... Overall and 5-year survival of all patients undergoing EMR was 67.9 months and 85%, respectively. Subset analysis of the 13 patients with R1 ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2468900925000672

Endoscopic submucosal dissection versus ... ESD significantly outperformed EMR in en bloc resection (RR = 2.22, 95% CI: 1.69–2.90; p < 0.001), R0 resection (RR = 1.93, 95% CI: 1.28–2.91; p ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6524998/

Mid- and long-term outcomes of endoscopic resection for ... Conclusions ER is viable treatment for esophageal submucosal cancer, selection between ESD/EMR can depend on tumor size and patient condition, ...

4. jtcvs.org jtcvs.org/article/S0022-5223(18)30730-X/fulltext

Outcomes after endoscopic mucosal resection or ... Low-risk patients had excellent outcomes regardless of treatment modality. Perspective. The use of endoscopic resection for submucosal esophageal cancer is ...

5. ascopubs.org ascopubs.org/doi/10.1200/jco.2009.27.15_suppl.e15569

Clinical outcome of endoscopic mucosal resection (EMR) ... Other 3 pts. followed by chemoradiotherapy, did not show cause specific death. Overall and cause specific survival rates at 5 years were 67.3% ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7591627/

The safety and efficacy of endoscopic submucosal ... In conclusion, ESD is more effective than EMR in the treatment of early oesophageal carcinoma, which was determined by its high en bloc resection rate, high ...

7. aoe.amegroups.org aoe.amegroups.org/article/view/6439/html

Endoscopic management of early esophageal cancer Studies have shown that the outcome for patients with T1 cancer is excellent, with a 5-year disease-specific survival rate exceeding 80%, whereas patients with ...