Double-blinded (treatment group unknown to physician and patient), randomised (treatment group allocated by chance) phase II trial on the efficacy and tolerability of an 8 week treatment with two different doses of budesonide tablets dissolving in the mouth compared to placebo (medication without active substance), for prevention of constrictions of the oesophagus in adult patients after removal of cancer tissue using an endoscopic surgery technique

INTERVENTION: Product Name: BUL03, Product Code:PRD6821711, Pharmaceutical Form: ORODISPERSIBLE TABLET, Other descriptive name: , Strength: , Product Name: BUL02, Product Code:PRD5759915, Pharmaceutical Form: ORODISPERSIBLE TABLET, Other descriptive name: , Strength: , Product Name: Placebo orodispersible tablets, Product Code:N/A, Pharmaceutical Form: N/A, Other descriptive name: N/A , Strength: , Pharmaceutical form of the placebo: N/A CONDITION: MedDRA version: 20.0Level: PTClassification code: 10004137Term: Barrett's oesophagus Class: 100000004856 MedDRA version: 21.0Level: LLTClassification code: 10030186Term: Oesophageal squamous cell carcinoma NOS Class: 10029104 MedDRA version: 21.0Level: PTClassification code: 10030137Term: Oesophageal adenocarcinoma Class: 100000004864 Prevention of oesophageal strictures in adult patients after endoscopic submucosal dissection ; MedDRA version: 20.0Level: PTClassification code: 10004137Term: Barrett's oesophagus Class: 100000004856 ; MedDRA version: 21.0Level: PTClassification code: 10030137Term: Oesophageal adenocarcinoma Class: 100000004864 ; MedDRA version: 21.0Level: LLTClassification code: 10030186Term: Oesophageal squamous cell carcinoma NOS Class: 10029104 Therapeutic area: Diseases [C] ‐ Digestive System Diseases [C06] PRIMARY OUTCOME: Main Objective: To assess the efficacy of eight weeks treatment with 2 x 1 mg/day or 2 x 2 mg/day budesonide orodispersible tablets vs. placebo for prevention of oesophageal strictures after endoscopic submucosal dissection Primary end point(s): Percentage of patients free of strictures at visit week 8 Secondary Objective: To study safety and tolerability of budesonide orodispersible tablets vs. placebo by means of adverse events and laboratory parameters, To assess patients' quality of life SECONDARY OUTCOME: Secondary end point(s):Number of endoscopic dilations per patient during the DB treatment phase Secondary end point(s):Percentage of patients free of strictures until the FU visit INCLUSION CRITERIA: Signed informed consent, Male or female patients, 18 to 85 years of age, Estimated life expectancy of at least one year (not applicable in Portugal);, ECOG Performance Status of = 2 at the randomisation visit (i.e. after the ESD‐procedure);, a) Biopsy proven or endoscopically suspect oesophageal SCC and/or high grade dysplasia in a focal lesion of the squamous epithelium, treated with ESD; or b) Biopsy proven or endoscopically suspect BE‐HGD or EAC, treated with ESD, Mucosal defect after ESD of a) = 50% oesophageal circumference in a patient with SCC, or b) = 75% oesophageal circumference in a patient with BE‐HGD or EAC, Negative pregnancy test in females of childbearing potential at the screening visit;, Women of childbearing potential agree to apply during the entire duration of the trial an effective method of birth control, which is defined as those, which result in a low failure rate (i.e., less than 1% per year) when used constantly and correctly. Such methods