D0387 - Safety and Efficacy of Endoscopic Dilation of Small Bowel Crohn’s Disease Strictures via Ileostomy

Tuesday, October 25, 2022

10:00 AM – 12:00 PM ET

Location: Crown Ballroom

Presenting Author(s)

Mihir S. Patel, MD, MBA

Cleveland Clinic
Cleveland, OH

Mihir S. Patel, MD, MBA¹, Joseph Sleiman, MD², Ruishen Lyu, MS³, Sara El Ouali, MD⁴, Florian Rieder, MD⁵
¹Cleveland Clinic, Cleveland, OH; ²UPMC, Pittsburgh, PA; ³Cleveland Clinic Foundation, Cleveland, OH; ⁴Cleveland Clinic Abu Dhabi, Al Maryah Island, Abu Dhabi, United Arab Emirates; ⁵Lerner Research Institute, Cleveland Clinic Foundation, Cleveland, OH

Introduction: Crohn’s disease (CD) manifests as a variety of phenotypes of which fibrostenotic strictures signify an increased risk of progression to obstructive complications. Medical management of stricturing CD is limited and often requires surgical interventions. Endoscopic balloon dilation (EBD) has emerged as an alternative to surgery in CD strictures. Data on EBD in CD strictures of patients with ileostomy is limited.

Methods: All CD patients who had undergone EBD for strictures via ileoscopies through a small bowel stoma performed at a tertiary medical center from February 2010 to December 2021 were included. Strictures were defined as the inability to pass an upper endoscope. Patients were followed until the date of stricture-related surgery or at least one month post EBD. Data on technical (ability to pass the scope after dilation) and clinical (symptom improvement) success, long-term efficacy, and complications were investigated.

Results: In total, 34 CD patients (59% female) with end ileostomies (88.2%) or diverting loop ileostomies (11.8%) were identified with a median follow-up of 18.3 months [Interquartile Range (IQR) 6.8, 45.3]. Median age at index EBD was 45 years [IQR 31.6, 56.7] The median maximal balloon dilation diameter at index EBD was 16.7 mm [IQR13.1, 18.3]. Technical success was achieved in 100% of the EBDs, with 91% of patients endorsing clinical success (improvement in symptoms). Obstructive symptoms recurred in 32% of patients. Repeat EBD was performed in 52.9% with a median time to dilation of 7.4 months [95% CI: 4, 17.8]. Furthermore, 41.2% of patients underwent one additional EBD and 14.7% had two or more additional EBDs. During follow-up, 47.1% underwent stricture-related surgery with a median time to resection of 35.2 months [95% C1: 21.1, 116.6]. There were no short-term complications within a week however long-term complications included an abscess in one patient and a fistula in another patient.

Discussion: EBD of small bowel CD-associated strictures through an ileostomy has a high rate of technical and clinical success with robust long-term efficacy. Serial dilation of the same stricture is feasible and the complication rate is low. EBD may allow clinicians to effectively postpone surgery for CD strictures in patients with an ileostomy.

Figure: Figure 1: (A) Kaplan-Meier cumulative incidence hazard curves for time to repeat EBD. (B) Kaplan-Meier cumulative incidence hazard curves for time to stricture-related surgery.

Variable	Level	All (n=34)	No (n=16)	Yes (n=18)	P-value	N
Age		45.0 [31.6;59.0]	51.8 [31.9;56.7]	41.3 [32.1;60.2]	0.918	34
Sex	Female	20 (58.8%)	12 (75.0%)	8 (44.4%)	0.145	34
Sex	Male	14 (41.2%)	4 (25.0%)	10 (55.6%)
BMI at time of EBD		22.5 [20.7;26.3]	23.0 [20.8;26.4]	22.2 [20.7;26.3]	0.986	34
Time since CD diagnosis (years)		20.1 [15.1;32.1]	20.3 [16.1;34.3]	19.4 [14.4;31.4]	0.666	34
Smoking History	Non-Smoker	25 (73.5%)	12 (75.0%)	13 (72.2%)	0.737	34
	Smoker	3 (8.82%)	2 (12.5%)	1 (5.56%)
	Former Smoker	6 (17.6%)	2 (12.5%)	4 (22.2%)
Disease Location	Stomach	2 (5.88%)	1 (6.25%)	1 (5.56%)	>0.999	34
	Duodenum	6 (17.6%)	5 (31.2%)	1 (5.56%)	0.078	34
	Jejunum/proximal ileum	15 (44.1%)	8 (50.0%)	7 (38.9%)	0.760	34
	Ileum	34 (100%)	16 (100%)	18 (100%)	N/A	34
	Ileocecal	34 (100%)	16 (100%)	18 (100%)	N/A	34
	Colon	29 (85.3%)	13 (81.2%)	16 (88.9%)	0.648	34
	Rectum	26 (76.5%)	11 (68.8%)	15 (83.3%)	0.429	34
	Perianal	13 (38.2%)	3 (18.8%)	10 (55.6%)	0.064	34
Extraintestinal Manifestations (EIM)	Yes	31 (93.9%)	13 (86.7%)	18 (100%)	0.199	34
Type of EIM	Eyes)	1 (2.94%)	0 (0.00%)	1 (5.56%)	>0.999	34
	Oral Ulcers)	5 (14.7%)	2 (12.5%)	3 (16.7%)	>0.999	34
	Joints	5 (14.7%)	3 (18.8%)	2 (11.1%)	0.648	34
	Skin	5 (14.7%)	1 (6.25%)	4 (22.2%)	0.340	34
	Anemia	20 (58.8%)	7 (43.8%)	13 (72.2%)	0.182	34
	PSC	1 (2.94%)	0 (0.00%)	1 (5.56%)	>0.999	34
	Malnutrition	25 (73.5%)	10 (62.5%)	15 (83.3%)	0.250	34
	Hypoalbuminemia	25 (73.5%)	10 (62.5%)	15 (83.3%)	0.250	34
	Other	1 (2.94%)	1 (6.25%)	0 (0.00%)	0.471	34
Montreal Classification	B2	4 (11.8%)	3 (18.8%)	1 (5.56%)	0.219	34
	B2p	7 (20.6%)	5 (31.2%)	2 (11.1%)		34
	B3	5 (14.7%)	1 (6.25%)	4 (22.2%)
	B3p	18 (52.9%)	7 (43.8%)	11 (61.1%)
Number of prior surgeries		6.00 [4.25;8.00]	5.50 [3.50;7.25]	7.00 [5.25;9.50]	0.150
Ostomy type at time of EBD	End Loop Ileostomy	30 (88.2%)	15 (93.8%)	15 (83.3%)	0.604	34
Ostomy type at time of EBD	Diverting Loop Ileostomy	4 (11.8%)	1 (6.25%)	3 (16.7%)
Time from date of ostomy creation to index EBD (years)		4.13 [2.07;7.02]	3.20 [1.91;7.80]	4.33 [2.95;6.90]	0.629	34
Stricture balloon size (cm)		1.80 [1.20;2.00]	1.80 [1.35;2.00]	1.50 [1.20;1.80]	0.315	19
Stricture maximum diameter of dilation during EBD (cm)		1.67 [1.31;1.83]	1.80 [1.35;2.00]	1.50 [1.20;1.80]	0.315	28
Total Number of strictures	1	25 (73.5%)	14 (87.5%)	11 (61.1%)	0.125	34
Total Number of strictures	2	9 (26.5%)	2 (12.5%)	7 (38.9%)
Hemoglobin (g/dL)		12.5 (2.26)	12.4 (2.04)	12.6 (2.49)	0.828	23
Albumin (g/dL)		3.71 (0.65)	3.58 (0.38)	3.84 (0.82)	0.365	21
CTE or MRE within 6 months prior to Index EBD		12 (35.3%)	11 (68.8%)	11 (61.1%)	0.916	34

Table: Table 1: Summary of descriptive statistics by status of repeat EBD.

Disclosures:

Mihir Patel indicated no relevant financial relationships.

Joseph Sleiman indicated no relevant financial relationships.

Ruishen Lyu indicated no relevant financial relationships.

Sara El Ouali indicated no relevant financial relationships.

Florian Rieder: 89Bio – Advisory Committee/Board Member, Consultant. AbbVie – Advisory Committee/Board Member, Consultant. Adnovate – Advisory Committee/Board Member, Consultant. Agomab – Advisory Committee/Board Member, Consultant. Allergan – Advisory Committee/Board Member, Consultant. Arena – Advisory Committee/Board Member, Consultant. Boehringer-Ingelheim – Advisory Committee/Board Member, Consultant. CDISC – Advisory Committee/Board Member, Consultant. Celgene/BMS – Advisory Committee/Board Member, Consultant. Cowen – Advisory Committee/Board Member, Consultant. Ferring – Advisory Committee/Board Member, Consultant. Galapagos – Advisory Committee/Board Member, Consultant. Galmed – Advisory Committee/Board Member, Consultant. Genentech – Advisory Committee/Board Member, Consultant. Gilead – Advisory Committee/Board Member, Consultant. Gossamer – Advisory Committee/Board Member, Consultant. Guidepoint – Advisory Committee/Board Member, Consultant. Helmsley – Advisory Committee/Board Member, Consultant. Horizon Therapeutics – Advisory Committee/Board Member, Consultant. Image Analysis Limited – Advisory Committee/Board Member, Consultant. Index Pharma – Advisory Committee/Board Member, Consultant. Janssen – Advisory Committee/Board Member, Consultant. Koutif – Advisory Committee/Board Member, Consultant. Mestag – Advisory Committee/Board Member, Consultant. Metacrine – Advisory Committee/Board Member, Consultant. Morphic – Advisory Committee/Board Member, Consultant. Organovo – Advisory Committee/Board Member, Consultant. Origo – Advisory Committee/Board Member, Consultant. Pfizer – Advisory Committee/Board Member, Consultant. Pliant – Advisory Committee/Board Member, Consultant. Prometheus Biosciences – Advisory Committee/Board Member, Consultant. Receptos – Advisory Committee/Board Member, Consultant. RedX – Advisory Committee/Board Member, Consultant. Roche – Advisory Committee/Board Member, Consultant. Samsung – Advisory Committee/Board Member, Consultant. Surmodics – Advisory Committee/Board Member, Consultant. Surrozen – Advisory Committee/Board Member, Consultant. Takeda – Advisory Committee/Board Member, Consultant. Techlab – Advisory Committee/Board Member, Consultant. Theravance – Advisory Committee/Board Member, Consultant. Thetis – Advisory Committee/Board Member, Consultant. UCB – Advisory Committee/Board Member, Consultant. Ysios – Advisory Committee/Board Member, Consultant.

Mihir S. Patel, MD, MBA¹, Joseph Sleiman, MD², Ruishen Lyu, MS³, Sara El Ouali, MD⁴, Florian Rieder, MD⁵. D0387 - Safety and Efficacy of Endoscopic Dilation of Small Bowel Crohn’s Disease Strictures via Ileostomy, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.