Trial document




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  DRKS00013026

Trial Description

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Title

Randomized Controlled Trial to Compare Hybrid-Argon-Plasma-Coagulation (Hybrid-APC) and Radiofrequencyablation in Treatment of Barrett´s esophagus with Low-Grade Intraepithelial Neoplasia and High-Grade Intraepithelial Neoplasia or After Primary Endoscopic Resection of Early Cancer in the Esophagus.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The present study investigates the treatment of esophageal cancer. Patients with Barrett´s esophagus have a risk to develop cancer ( 0.2-0.5 % per year). This happens by changing the Barrett´s mucosa over different steps to invasive cancer. A two step approach has been established for therapy. In the first step endoscopic resection is carried out to all visible neoplasia. Studies could show, that it is very important to treat also the non-neoplastic Barrett´s mucosa in a second step. By missing this second treatment, almost 1/3 of all patients will develop recurrence neoplasia. This treatment is carried out by applying heat to the mucosa. Two different methods come into question.
1. Argonplasma coagulation with or without prior saline injection (Hybrid) and 2. Radiofrequencyablation. Both methods are safe and have good results. However, both devices have relevant complications. Besides direct complications as bleeding, perforation and pain, they might lead to late complications like stenosis. Furthermore eradication of all Barrett´ mucosa is not possible in all patients. According to results of present studies it remains unclear which of the two methods are the best. There are no randomized trials so far comparing these options. This study investigates therefore both methods in a prospective randomized trial.

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Brief Summary in Scientific Language

The present study investigates the treatment of esophageal adenocarcinoma. Patients with Barrett´s esophagus have a risk to develop cancer ( 0.2-0.5 % per year). This happens by a carcinoma sequence from intestinal metaplasia over different steps to invasive cancer. A two steps approach have been established for therapy. In the first step endoscopic resection is carried out to all visible neoplasia. Studies could show, that it is verry important to treat also the remaining non-neoplastic Barrett´s mucosa in a second step. By missing this second treatment, almost 1/3 of all patients will develop recurrence of neoplasia. This treatment is carried out by applying ablative therapy to the mucosa. Two different methods come into question.
1. Argonplasma coagulation with or without prior saline injection and 2. Radiofrequencyablation. Both methods are safe and show good results. However, both devices have also relevant complications. Besides direct complications as bleeding, perforation and pain, they might lead to late complications like esophageal stenosis. Furthermore eradication of all Barrett´ mucosa is not possible in every patient. According to results of present studies it remains unclear which of the two methods are the best. There are no randomized trials so far comparing these two options. This study investigates therefore both methods in a prospective randomized trial.

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Organizational Data

  •   DRKS00013026
  •   2017/11/28
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  •   yes
  •   Approved
  •   FF100/2017, Ethikkommission der Landesärztekammer Hessen
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Secondary IDs

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Health Condition or Problem studied

  •   C15.9 -  Malignant neoplasm: Oesophagus, unspecified
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Interventions/Observational Groups

  •   Hybrid Argon-Plasma-Coaguation with a maximum of 5 sessions per patient
  •   Radiofrequencyablation with a maximum of 5 sessions per patient
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   No
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Primary Outcome

Primary target is the complete eradication rate of all neoplasia and Barrett´s epithelium, measured by a neagative follow-up endoscopy with biopsy (histologic and macroscopic response). Follow-up endoscopy is planned after 3-6-12 and 24 months. All patients will recieve invitation for a long-term follow-up after 5 years.

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Secondary Outcome

• Number of ablation sessions needed.
• Initial (30 days) and late post interventional complications ( Pain, dysphagia, fever, bleeding, stenosis, mortality) and their therapy, particularly stenosis and specialized therapy (Number of dilatations needed).
• Barrett´s recurrence after 1 and 2 years after complete eradication and after long term 5 years follow-up.
• Operating time
• Evaluation for Risk for neoplasia in the neo-Barrett by systematic biopsies during all follow-up endoscopies.
• Prospective evaluation of wound healing.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/11/30
  •   314
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   85   Years
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Additional Inclusion Criteria

Patients with Barrett´s mucosa after endoscopic resection of all visible lesions. Barrett´s length ≥ 1 cm with maximum of high-grade intraepithelial neoplasia.
Patients without visible lesions after carefully inspection by second endscopy (High -definition endoscopes and chromoendoscopy) and confirmed intraepithelial neoplasia by a second pathologist.

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Exclusion Criteria

• Age under 18 years and over 85 years
• Patients unable to give consent
• Pregnancy
• Insufficiant endoscopic therapy after more than 3 endoscopic interventions.
• Patients after radiofrequency ablation, Argon-plasma-coagulation or any other ablativ therapy
• Patient with non-dysplastic Barrett´s esophagus
• Barrett length < 1cm
• Patients with severe esophageal stenosis after endoscopic resection.
• Patients with diagnosis of non currative severe carcinoma
• Patients with coagulation disorder
• Missing written consent

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Sana Klinikum Offenbach
    • Ms.  Prof, Dr  Andrea  May 
    • Starkenburgring 66
    • 63069  Offenbach am Main
    • Germany
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    • Sana Klinikum Offenbach
    • Mr.  Dr med  Mate  Knabe 
    • Starkenburgring 66
    • 63069  Offenbach am Main
    • Germany
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    • Sana Klinikum Offenbach
    • Mr.  Dr med  Mate  Knabe 
    • Starkenburgring 66
    • 63069  Offenbach am Main
    • Germany
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Sources of Monetary or Material Support

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    • Sana Klinikum Offenbach
    • Ms.  Prof, Dr  Andrea  May 
    • Starkenburgring 66
    • 63069  Offenbach am Main
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.