A RANDOMIZED COMPARISON OF DEGRADABLE ESOPHAGEAL STENT VS DILATION THERAPY: *DESTINY TRIAL* FOR PATIENTS WITH RECURRENT BENIGN ESOPHAGEAL STRICTURES

Recurrent benign esophageal strictures are a regular cause of dysphagia and
significantly impair quality of life. The treatment algorithm for patients with
recurrent benign esophageal strictures, which is mostly based on experts*
opinions, states that after failure of standard dilation, steroid injections
can be added or electrocautery incisions can be performed. If strictures remain
refractory (approximately 10% of patients), esophageal stent placement for
prolonged dilation can be attempted. No randomized trials have been performed
to evaluate whether stent placement earlier in the treatment algorithm could be
more effective and reduces the number of repeat dilations. Based on data of
previously performed studies, it was hypothesized that patients with recurrent
benign strictures may benefit from early stent placement.

To compare the efficacy and safety of dilation of recurrent benign esophageal
strictures by using a degradable self-expanding stent or standard dilation
therapy.

International multicenter, randomized controlled trial conducted in the
European Union

Standard dilation therapy (balloon or bougie dilation) to 18 mm vs. placement
of a degradable stent (SX-ELLA Stent Esophageal Degradable BD (Ella-CS, s.r.o.,
Czech Republic)) with a diameter of 18, 20, or 23 mm.

The potential benefit of study participation is the possibility for early stent
placement, which implies a prolonged dilation period, earlier in the treatment
algorithm than routinely performed. This may result in a longer dysphagia free
period and a reduction of repeat endoscopies for patients with recurrent or
refractory strictures, who would otherwise be frequently dilated. As it is
currently not know whether this is indeed beneficial, the benefit of study
participation is uncertain.

The risk associated with stent placement may be slightly higher as well, as
retrosternal pain occurs more frequently after stent placement than after
dilation therapy (15% vs. 0-5%). In most cases, pain is very well treated with
analgesic and resolves within a week. Stent migration occurs in less than 10%
of patients. In most of these cases, no interventions (such as stent removal)
are required as the stent rapidly degrades, due to the low pH in the stomach.
For patients being treated with bougie or balloon dilation, the risk of
perforation is 0.5%. Perforation rate after BD stent placement is unknown,
although a systematic review in a similar population has shown that
perforations are rare (2%) when previous, rather stiff plastic stents designs
were placed. This suggests that perforation rate after BD stent placement would
at least be similar or lower than 2%. The risk of higher complication rates (5%
vs. 15%) is considered justifiable due to the expected beneficial long term
outcome in patients who receive BD stent placement. The number of repeat
endoscopies for repeat dilation, which is also considered a major burden to
patients, will probably be significantly lower in the BD stent group.

The burden of study participation to patients consists of 8 follow-up phone
calls taking approximately 15 minutes with a questionnaire and questions
regarding dysphagia. BD stent patients will have one follow-up visit at 3
months that requires radiographic assessment. If the gold markers are seen at
the 3 month assessment; then at 6 months, the patient will come back for
another radiographic assessment. The questionnaire will also be completed
during this visit. No additional study visits are necessary.