We hypothesize that endoscopic combination therapy, including in- and excision of the stenotic fibrotic ring combined with steroid injections and bougie dilation, is more effective than standard repeated endoscopic bougie dilation.
ID
Bron
Verkorte titel
Aandoening
Benign esophageal strictures; Anastomotic strictures; Esophagectomy; Endoscopic dilation; Endoscopic incision
Benigne slokdarmstenosen; Naadstenosen; Slokdarmresectie; Endoscopische dilatatie; Endoscopische incisie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Dysphagia-free period
Achtergrond van het onderzoek
The study terminated due to lack of patient recruitment.
Doel van het onderzoek
We hypothesize that endoscopic combination therapy, including in- and excision of the stenotic fibrotic ring combined with steroid injections and bougie dilation, is more effective than standard repeated endoscopic bougie dilation.
Onderzoeksopzet
6 months of follow-up
Onderzoeksproduct en/of interventie
Intensive endoscopic therapy (=investigational treatment):
a) Endoscopic in- and excision of the stenotic fibrotic ring using a needle knife catheter.
b) Followed by injection of 0.5 ml aliquots Kenacort 40 mg/ml (= 20 mg of triamcinolone per injection) into 4 quadrants of the lesion.
c) Hereafter, the incised stricture is subsequently dilated up to 16 mm with bougienage. At the end of the procedure, the lesion is inspected endoscopically and pictures are taken.
d) The patient is scheduled for an additional endoscopic dilation procedure within approximately 1 week (range 5-9 days) during which the patient will be dilated up to a luminal diameter of 18 mm using bougie dilators.
Conventional, repeated endoscopic bougie dilation (= control group): Patients will be treated with endoscopic bougie dilation until a luminal diameter of 18 mm is reached. The endoscopic procedures will be scheduled within approximately 1 week (range 5-9 days) following one another.
Publiek
E.E. Halsema, van
Department of Gastroenterology & Hepatology, C2-310
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31(0)205668708
e.e.halsemavan@amc.nl
Wetenschappelijk
E.E. Halsema, van
Department of Gastroenterology & Hepatology, C2-310
Meibergdreef 9
Amsterdam 1105 AZ
The Netherlands
+31(0)205668708
e.e.halsemavan@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Untreated benign esophagogastric anastomotic stricture after esophagectomy.
- The stricture should be suitable for endoscopic incision:
a) Diagnosed at least 6 weeks after esophagectomy, and
b) Stricture length ≤ 1 cm.
- Dysphagia score ≥ 2.
- Age > 18 years.
- Written informed consent for study participation.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5764 |
| NTR-old | NTR6006 |
| CCMO | NL57698.018.16 |
| OMON | NL-OMON42848 |