|- candidate number||24050|
|- NTR Number||NTR6006|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-feb-2016|
|- Secondary IDs||NL57698.018.16 |
|- Public Title||Intensive endoscopic therapy versus standard treatment for untreated benign esophageal strictures resulting from excessive scar tissue formation after surgery|
|- Scientific Title||Intensive endoscopic therapy versus conventional treatment for untreated benign anastomotic strictures after esophagectomy: a pilot and randomized controlled trial|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Oesophagectomy|
|- Inclusion criteria||- 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.
|- 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.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2016|
|- planned closingdate||1-sep-2019|
|- Target number of participants||89|
|- Interventions||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.
|- Primary outcome||Dysphagia-free period|
|- Secondary outcome||Number of endoscopic dilations, technical success, procedure-related complications, dysphagia scores and therapy satisfaction score.|
|- Timepoints||6 months of follow-up|
|- Trial web site||NA|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD E.E. Halsema, van|
|- CONTACT for SCIENTIFIC QUERIES||MD. Jeanin Hooft, van|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam|
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||29-feb-2016 - 1-sep-2017|