Endoscopic Balloon Dilatation of stenotic ileocecal anastomosis in Crohn*s disease with or without additive local steroid injection and oral Budenofalk* a double-blind, randomized, parallel group trial

Crohn*s disease may affect the entire digestive tract but is mostly located in
the ileocecal region (1). In 30% percent of the cases the disease is
characterized by formation of strictures leading to bowel obstruction (2,3,4).
Up to 80% of CD patients will eventually require at least one surgical
resection within the first ten years after diagnosis (5,6). Most of these
patients require multiple resections during the course of their disease, which
may eventually result in short bowel syndrome. Stenosis of the anastomotic site
as a cause of inflammation and fibrosis is a frequent long term complication
(50-70%) after an ileocecal resection (10).
When a stenotic anastomosis is present there are several treatment options.
Surgical resection or stricturoplasty of the strictured segment is often
required. Research has shown that an operation can efficiently and safely be
postponed or even prevented by Endoscopic Balloon Dilatation (EBD)(11-18). When
EBD of a stenotic enteral anstomosis is performed a balloon catheter is guided
through the lumen of an endoscope to the anastomosis. Here the balloon is
inflated until enduring adequate dilatation is reached. Often multiple
dilatation sessions are required for the desired result.
Retrospective studies have shown that additive local anti-inflammatory therapy
(by injection of a long acting steroid at the site of the anastomosis and/or a
locally acting steroid) is safe and may decrease the need for redilatation
and/or surgical intervention (19,20). In these studies a Triamcinolone solution
(8 mg/mL or 40 mg/mL) was used, whereby four-quadrant injections of 0,5-1 mL
were performed at the most inflamed and narrowed area*s. There is only one
prospective study on the benefit of local injection of Triamcinolon (21). The
authors concluded from this pilot study that there is no benefit for
Triamcinolon injection. However, a low dose of Triamcinolon was used (8 mg/mL).
Furthermore, it may be hypothised that adding oral anti-inflammatory drugs may
cause more enduring results.
The standard approach for assessing the extend of a stenotic segment was the
Enteric Follow Through examination (EFF). This is a radiological procedure in
which a fluid contrast medium is injected through a catheter into the enteric
lumen. Nowadays, EFF has largely been replaced by MR Enteroclysis and MR
Enterography, both using non-ionizing magnetic resonance. The latter has been
shown to be equally effective in assessing intestinal stenoses and is better
tolerated by patients since there is no need to position a nasogastric tube
(22). Fluoroscopic imaging is another option for assessing stenoses in the
intestinal lumen. Fluoroscopy uses a contrast medium that is applied with a
through-the-scope catheter during colonoscopy. Fluoroscopy gives a real-time
image of the stenotic anastomosis and a possible pre-stenotic dilatation. There
are no standardized scoring systems for stenoses using fluoroscopy. A
radiological index would be very practical in clinical routine (Radiological
Crohn*s Disease Anastomotic Index, RCDAI).

The primary objective of this study is to evaluate whether adding intensive
local anti-inflammatory therapy (Triamcinolone injection therapy combined with
9 mg oral BudenoFalk once daily for 24 weeks) to routine enteric balloon
dilatation reduces the recurrence of stenosis and/or need for surgical
intervention in Crohn*s disease patients with a symptomatic anastomosis.

This is a randomized, double blind, clinical trial. The study will be conducted
with two arms in the form of a parallel group comparison and will serve to
compare two different approaches to dilating a stenosised anastomosis in
Crohn*s disease. Patients with a symptomatic stenosis will be treated.
Patients will undergo an ileocolonoscopy for mucosal assessment of the
anastomosis, and radiologic assessment (MR enterography and abdominal
ultrasound).
During screening colonoscopy a fluoroscopy will also be performed. The images
will be compared to the images from the former EFF by an experienced
radiologist together with the gastroenterological department.

Group A:
Triamcinolone injection therapy (0,5 - 1 ml 40 mg/mL solution in four
kwadrants) combined with 3 capsules (9 mg) oral BudenoFalk once daily for 20
weeks. At week 20 patients have to start tapering Budenofalk with 3 mg (1
capsule) per 2 weeks.
Group B:
Placebo injection therapy combined with 3 placebo capsules once daily for 20
weeks. At week 20 patients have to start tapering the placebo with 1 capsule
per 2 weeks.

Burden for the patient:
- IBDQ and VAS score
- 7 UMU visits
- Adverse events:During treatment with drugs one can experience adverse
reactions. The most reported reactions of Budenofalk are tremors, diarrhea,
dermal reactions, itching, intestinal symptoms, nausea, muscle cramps and
flatulance.
- Risks of procedures:
The possible risks of endoscpy are swelling of the abdomen and fainting.
Seldomly other complications occur, namely damaging of the intestine possibly
acquiring surgical intervention, internal bleeding, problems with the haert or
bloedvessels, respiratory problems and/or infections.
The risks of an endoscopic balloon dilatation are damaging of the intestine
possibly acquiring surgical intervention and internal bleeding possibly
necessitating blood transfusion. .
The risks of injection of Triamcinolon in the intestinal wall are not
investigated properly. Risk of damaging of the intestine possibly acquiring
surgical intervention and internal bleeding should be taken into acount
possibly necessitating blood transfusion.