To prolong the dysphagia-free period and to reduce the number of endoscopic dilations for patients with newly diagnosed, untreated benign anastomotic strictures after esophagectomy.
ID
Source
Brief title
Condition
- Gastrointestinal stenosis and obstruction
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Dysphagia-free period.
Secondary outcome
Number of endoscopic dilations, technical success, procedure-related
complications, dysphagia scores and therapy satisfaction score.
Background summary
One of the major issues after esophagectomy is the development of a benign
anastomotic stricture, which occurs in up to 43% of patients. Endoscopic bougie
or balloon dilation is currently the standard treatment to resolve dysphagia
caused by anastomotic strictures. However, patients usually require repeated
endoscopies to achieve a satisfactory luminal diameter with endoscopic dilation
and stricture recurrence is common (50%). 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.
Study objective
To prolong the dysphagia-free period and to reduce the number of endoscopic
dilations for patients with newly diagnosed, untreated benign anastomotic
strictures after esophagectomy.
Study design
A Dutch multicenter, two-stage clinical trial, including a (*phase-II*) pilot
study followed by an open-label, randomized controlled trial comparing
intensive endoscopic therapy with conventional repeated bougie dilation.
Intervention
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.
Study burden and risks
The investigational treatment is supposed to prolong the dysphagia-free period
and reduce the number of endoscopic dilations for patients with benign
esophageal anastomotic strictures. Therefore, potential benefits for study
subjects are a longer relief of dysphagia and a decrease in the number of
endoscopic re-interventions.
The main risks of intensive endoscopic therapy are the occurrence of
perforation and bleeding. These risks are expected to be low (< 2%).
The burden of study participation consists of telephone contact after 14 days
and thereafter monthly until 6 months of follow-up for answering questions
about dysphagia symptoms and therapy satisfaction. No additional hospital
visits are foreseen.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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.
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2016-001853-41-NL |
| CCMO | NL57698.018.16 |
| OMON | NL-OMON29569 |