E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Benign esophagogastric anastomotic strictures after esophagectomy |
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E.1.1.1 | Medical condition in easily understood language |
Benign stricture in the esophagus due to excessive scar tissue formation after esophageal resection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Digestive System Diseases [C06] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10030199 |
E.1.2 | Term | Oesophageal stricture |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015449 |
E.1.2 | Term | Esophageal stricture |
E.1.2 | System Organ Class | 100000004856 |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10030215 |
E.1.2 | Term | Oesophagectomy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015460 |
E.1.2 | Term | Esophagectomy |
E.1.2 | System Organ Class | 10042613 - Surgical and medical procedures |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To prolong the dysphagia-free period for patients with newly diagnosed, untreated benign anastomotic strictures after esophagectomy |
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E.2.2 | Secondary objectives of the trial |
To reduce the number of endoscopic dilations for patients with newly diagnosed, untreated benign anastomotic strictures after esophagectomy |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Untreated benign esophagogastric anastomotic stricture after esophagectomy. • The stricture should be suitable for endoscopic incision: - Diagnosed at least 6 weeks after esophagectomy, and - Stricture length ≤ 1 cm. • Dysphagia score ≥ 2 = ability to swallow semi-solid food or worse. • Age > 18 years. • Written informed consent for study participation. |
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E.4 | Principal exclusion criteria |
• Benign esophageal stricture other than an esophagogastric anastomotic stricture. • Strictures with a morphology unsuitable for needle-knife incision, such as long (> 1 cm), irregulair or tortuous strictures. • Previous endoscopic treatment of the esophageal stricture, such as bougie/balloon dilation, steroid injection, incision therapy or stent placement. • Previous stent placement post-esophagectomy for anastomotic leakage. • (Suspicion of) recurrent or metastasized esophageal cancer. • Persisting postoperative esophageal fistula. • Inability to discontinue anticoagulants or high-dose antiplatelet drugs at time of the baseline procedure. Low-dose aspirin (max. 100 mg/day) may be continued. • Known clotting disorder. • Patients unable to provide written consent for the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The dysphagia-free period |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Total number of endoscopic dilation procedures. • Number of days from the first endoscopic procedure to the ability to tolerate a normal diet. • The technical success of the intensive endoscopic therapy and conventional repeated endoscopic bougie dilation. • Procedure-related complications. • Therapy satisfaction score.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
14 days and thereafter monthly evaluation until 6 months of follow-up have been completed |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Conventional endoscopic bougie dilation |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Once the last visit of the last subject had been completed.
Also the following stopping regulations will be applied: When a third major event occurs related to the investigational treatment the trial will be terminated due to an increased safety risk that does not outweigh the potential benefits of the treatment. A major event should be related to the investigational treatment. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |