A multicenter, double blind placebo-controlled randomised trial for benign esophageal anastomotic strictures: Savary dilation vs savary dilation with triamcinolon

Dysphagia due to benign esophageal stricture formation can significantly impair
quality of life. Adequate treatment of these strictures is of utmost
importance. Dilation is the mainstay of this treatment and can be performed by
balloon dilatation or by Savary Gilliard bougienage. Both treatments have shown
to be equally effective and safe, however Savary Gilliard dilations are
re-useable, making this a more cost-effective method.
Strictures can be classified according to complexity. In general, peptic
strictures are simple, focal and straight and require only 1-3 dilations to
relieve dysphagia. Complex strictures are longer (>2 cm), angulated, irregular
or with a severely narrowed diameter. The most common complex strictures
include anastomotic, post-radiation or caustic strictures. These strictures are
frequently refractory to dilation and require multiple (>5) sessions sometimes
at weekly intervals.
Stricture formation at the site of the anastomosis after esophagectomy is
increasingly reported as a common cause of benign esophageal strictures,
whereas reflux disease less frequently causes stricture formation, probably due
to the increased use of PPI*s (proton pump inhibition).
Addition of intra-esophageal triamcinolon injections to dilatation was first
mentioned in 1969, but this technique has only been increasingly employed over
the last decade. Several prospective studies have demonstrated its use in dogs,
adults and children. Triamcinolon was found to be safe and effective in
lengthening the dilation-free interval and reducing the risk for recurrent
stricture formation in patients with strictures of all causes, but also in
prospective series with peptic or corrosive strictures solely. However, a major
disadvantage of these studies is the lack of a randomised study design. Four
randomized trials (of which one is only available in Portuguese language and
one only published only in abstract form) have compared both mechanical and
balloon dilators with intralesional steroid injections vs dilation alone. Two
trials showed a significantly increased dilation free interval for the steroid
arm and one showed an increase in stricture diameter in the steroid arm. In one
study only 13% needed a re-intervention due to recurrent dysphagia in the
steroid group whereas 60% needed re-intervention in the control group. This
study included only patients with refractory peptic strictures, whereas the two
other trials included patients of all sorts of strictures and patients with
corrosive strictures, respectively. However, a trial including patients with
anastomotic strictures alone has not yet been performed. In only one study, a
standardized technique and symptom scoring system was applied and blinding of
patients and effect investigators was adequately performed.

To compare Savary dilation with saline 0.9% injections (placebo) with Savary
dilation with triamcinolon injections in patients with benign anastomotic
esophageal strictures

A multicenter, double-blind, placebo controlled randomized controlled trial

Patients in treatment arm A will be treated with Savary Galliard dilation with
four intralesional saline 0.9% injections of 0.5 ml in all four quadrants and
patients in treatment group B receive Savary dilation with four intralesional
triamcinolon 0.5 ml injections 40 mg/ml in all four quadrants. Savary dilation
will be performed untill a diamter of 16 mm is achieved. In case of pinpoint
strictures, two or more dilation session are required within one week to
achieve this diameter (without additional injections).

Patients will be asked to fill in a questionnaire on their symptoms before
first treatment, and patients will be contacted by phone after t=2 weeks, t=1
month,t=3 months and t=6 months for another questionnaire. After one week
patients will be contacted to inform about possible mild complications after
the intervention. Furthermore, patients will document their dysphagia score
daily for the first month, thereafter, they will document their dysphagia score
once weekly only. No additional hospital visits or blood samples are required.
The main risks of dilation (with or without steroids) is hemorrhage or
perforation ( 0.1-0.4%). Furthermore, during all reported dilations with
steroid injections, only one case of local candida infection was reported,
which was effectively treated with ketaconazol.
The potential benefit expected in the study arm will be a longer dilation free
interval and less dilation sessions to achieve relief of dysphagia.