Evaluating the Predictors of Endoscopic Balloon Dilation Failure, Success and Surgery Prevention in Crohn's Disease-related Strictures

doi:10.21203/rs.3.rs-4809898/v1

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Evaluating the Predictors of Endoscopic Balloon Dilation Failure, Success and Surgery Prevention in Crohn's Disease-related Strictures

https://doi.org/10.21203/rs.3.rs-4809898/v1

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Background: Long-term outcomes after endoscopic balloon dilation (EBD) for managing fibro-stenotic strictures in patients with Crohns disease (CD) are poorly defined in the literature. Aims of this study are to evaluate the efficacy of EBD in delaying surgery for the treatment of CD-related strictures and identify clinical, endoscopic, and stricture-related factors associated with avoidance of surgery after five years of EBD.

Methods: Retrospective cohort study including patients with CD undergoing EBD at a tertiary academic center from 01/2007-12/2021. Demographics, surgical and medication history, disease and stricture characteristics, need for surgical intervention, time to surgical intervention, and need for re-dilation were collected. Outcomes were followed from index dilation up to five years post-dilation.

Results: 422 patients with CD (53.3% female, mean age 45) underwent EBD during the study period (813 total dilations). Location of the stricture was upper gastrointestinal in 24 patients (7%), and ileal (37.3%), colonic (13.2%), ileocolonic (47.8%) in others. 135 participants (32%) required surgery for CD-related stricture during the 5-year follow-up period. 181 patients (42.9%) required re-dilation. Prednisone therapy was a predictor for progression to surgery post-EBD (p=0.002). Patients with De Novo strictures were more likely to undergo surgery compared to those with anastomotic strictures (p=0.004). Eight patients (2%) had complications, with 3 of those requiring surgery.

Conclusion: 68% of patients who underwent EBD avoided surgery. Steroid therapy was predictive of surgical resection within 5 years. Similar to existing literature, anastomotic strictures had better outcomes than De Novo.

Endoscopic Balloon Dilatation

Crohn’s Disease

Intestinal Strictures

Surgical Intervention

Therapeutic Endoscopy

EBD is a minimally invasive option for Crohn’s disease related strictures. We evaluated the efficacy of EBD in delaying surgery for the treatment of strictures and identified associations with surgery during five years of treatment.

1. What is already known? EBD represents a minimally invasive intervention for CD-related strictures that is known to have high rates of immediate success, but long-term efficacy is not well studied.

2. What is new here? This is the largest single-center study looking at EBD outcomes for treatment of CD-related strictures, with specific patient and stricture characteristics predictive of outcomes.

3. How can this study help patient care? Identifying these predictors can guide clinicians in optimizing management strategies for individuals with CD, potentially reducing the need for surgical intervention.

Crohn’s Disease (CD) is a subtype of inflammatory bowel disease (IBD) characterized by granulomatous transmural inflammation affecting any portion of the gastrointestinal tract [1]. This relapsing and remitting condition can lead to a variety of complications such as fibro-stenotic and inflammatory strictures, fistulas and abscesses.

Intestinal strictures are common complications of Crohn’s disease (CD) and affect one-third of the patient population within 10 years of disease onset [2,3]. This is one of the most common indications for surgical resection. Anastomotic strictures postoperatively are observed in about 40% of patients within four years [4]. In addition, intestinal resection can lead to a loss of functional segments of the bowel potentiating consequences such as short bowel syndrome, bile acid diarrhea, small intestinal bacterial overgrowth, vitamin deficiencies, dysbiosis of the gut microbiome, and re-stenosis at the anastomotic site. Thus, managing CD is known to be an evolving therapeutic challenge requiring a multimodal approach tailored to address symptomatic response and subsequent tolerance of the intervention [5].

Strictures can develop anywhere in the GI tract but are most commonly seen in the ileum and ileocolonic region or at a prior surgical anastomosis, especially in those with an ileocolonic anastomosis. A predominantly inflammatory stricture may respond to medical therapy, especially with advancements in treatment. However, fibrotic strictures do not typically respond to medical therapy and may require endoscopic or surgical intervention. EBD is a minimally invasive procedure for managing fibro-stenotic strictures in patients with Crohn’s disease [4]. This has been established as an alternative option to surgery depending on the stricture’s characteristics. It may result in intestinal preservation with avoidance of surgery or maybe a temporizing measure and bridge to surgery. It can be used as first-line therapy for strictures. The approach to CD-associated strictures is individually customized according to the degree of fibrosis, penetrative disease, and inflammation [6,7]. Primary strictures are thought to be a result of tissue remodeling due to chronic inflammation and secondary strictures typically occur at the surgical anastomosis [8].

EBD has a high rate of immediate technical success usually defined as the ability of the scope to traverse the stricture after dilation. Rates range from 75% to as high as 97%. Long-term efficacy of EBD has been defined as the time until the next intervention whether it is repeat endoscopic dilation or surgical resection [9]. According to recent meta-analysis, previous studies evaluating EBD have yielded promising results with a high percentage of symptomatic response and low complication rates [10]. Further studies are needed to better define parameters of EBD success and to identify which patients are better served by EBD as an alternative to surgery.

This study aims to describe the efficacy and safety of EBD in treating strictures and its ability to prevent or delay surgery in patients with Crohn’s Disease. In addition, we evaluated the factors that predicted surgical intervention versus EBD.

Study Design

This was a retrospective cohort study including all patients with CD who underwent EBD at Indiana University, a tertiary academic center, between January 2007 to December 2021. Patient outcomes were followed from their index dilation for up to five years post dilation.

Population

The study population consisted of adults (18 years and older) diagnosed with Crohn’s Disease complicated by strictures identified by endoscopy. Patients were identified from the EMR (Electronic Medical Record) using ICD 9 and ICD 10 codes with the diagnosis of Crohn’s with stricture and EBD as key words. Diagnosis of Crohn’s was confirmed with two encounters containing the ICD 9 and ICD 10 codes for Crohn’s. Also, individuals included had endoscopic treatment with balloon dilation of their strictures between January 2007 and December 2021. Individuals who were less than 18 years of age, whose index dilation was outside of the time period stated above, or had strictures not related to Crohn’s Disease were excluded from the study.

Demographic data (age, gender, race, BMI), smoking status, disease characteristics (Montreal classification, phenotype, severity), stricture characteristics (location, size, number, severity), type of stricture (de novo versus anastomotic), surgical history, clinical history, medication history (use of steroids, biologics), need for surgical intervention, time to surgical intervention, need for re-dilation, and time to re-dilation were collected from the Electronic Medical Record.

Treatment complications were captured and included intestinal perforation, bleeding, post-procedural pain and hospitalization. Endoscopic severity of the disease was collected using the SES-CD and Rutgeert’s score.

Treatment success was defined as preventing surgery after completion of the dilation or series of dilations. The initial selection of balloon diameter is based on an approximation of the starting diameter of the lumen. Typically, a graded dilation technique is recommended for the initial dilation of a stricture. Our goal at our institution for the maximum balloon diameter was at least 18 to 20 mm which is the largest size available for a TTS (through-the-scope) balloon dilator. It was completed over one session or if necessary multiple sessions and a smaller diameter may be acceptable in the small bowel if deemed appropriate by the endoscopist.

Outcomes

The primary outcome of this study was to assess the efficacy of EBD in delaying or preventing surgery for the treatment of strictures in patients with Crohn’s Disease.

Secondary outcomes were to evaluate the safety of EBD in individuals with Crohn’s disease and analyze differences in outcomes between primary and anastomotic strictures. Additionally, we sought to characterize outcomes specifically in individuals with upper GI tract strictures. Finally, we evaluated the stricture and patient phenotype that predicted successful outcomes with EBD and prevented surgery.

Statistical Analysis

Descriptive characteristics were used to describe the patient cohort with the use of frequencies, median and means as appropriate. Statistical comparisons were performed with a chi-square test or Fischer’s exact test for categorical variables. ANOVA and Kruskal-Wallis tests were used for continuous variables. Statistical analyses were carried out using JMP Statistical Software version 17.0.

Study Population Characteristics

422 patients with Crohn's Disease (CD) underwent EBD for the management of their strictures and were included in this study. The mean age of the cohort was 45 years (Standard Deviation (SD) 16), 53.3% were female. The mean disease duration was 16 years (SD 13) years at the time of dilation. The majority of the patients were Caucasian (94.1%), with a smaller proportion of African American individuals (4.5%). The mean body mass index (BMI) was 26.6 kg/m²(SD 6.4). Crohn’s disease was classified according to the Montreal classification, with 31.5% of patients having both stricturing and penetrating disease, and 68.5% of patients having only a stricturing phenotype. Perianal disease was noted in 31.5% of cases. Patients who underwent surgery after dilation were more likely to have penetrating (p-value = 0.0005) and perianal disease (p = 0.02) compared to those who didn’t require surgery. Stricture location was predominantly ileocolonic (45.8%). Other locations of the strictures included ileal (27.9%), colonic (12.9%), upper GI (5.7%), jejunal (1.7%) and anal (5.7%). Anastomotic strictures comprised 41.4% of the cases. Full details on demographics and clinical characteristics can be found in Table 1.

Treatment Regimen and Endoscopic Characteristics at Dilation

This study analyzed 813 total dilations. The mean number of dilation sessions per patient was 1.9 (SD 2). 26.3% were on anti-TNF (tumor necrosis factor) therapy at time of dilation while 8.1% were on anti-integrin agents, 6.2% on Ustekinumab, 11% on immunomodulators (thiopurines, methotrexate), and 13.6% on combination therapy (anti-TNF with immunomodulator). 66 patients (15.7%) were taking prednisone at the time of dilation, while 28 patients (6.7%) were on budesonide. Regarding endoscopic severity of disease at time of dilation, 30.2% of patients had mild disease, while 31.0% and 25.2% had moderate and severe disease respectively as per SES-CD scoring. Detailed characteristics are presented in Table 2.

Outcomes of Endoscopic Balloon Dilation

The mean follow-up duration post-index dilation was 1155 days (IQR 387-1989 days). During this time, 287 patients (68%) required no further surgical intervention for their treated strictures. 181 patients (42.9%) required re-dilation in the follow-up period. The strictures were traversed in 81.4% of patients after index dilation. Eight patients (2%) had complications (perforation, bleeding) after dilation with three of them requiring surgery.

Notably, prednisone therapy at the time of dilation was a significant predictor for surgical intervention within the follow-up period (24.4% prevalence among those requiring surgery vs 11.6% among those who did not require surgery, p=0.0007), Figure 1. Additionally, individuals with de novo strictures were more likely to undergo surgery compared to those with anastomotic strictures (p=0.004), Figure 2.

Additionally, we performed a multivariate analysis looking at the risk factors for progression into surgery after EBD and found that the use of prednisone at the time of dilation increases the chance of requiring surgery (OR 3.59 [1.24-10.41], p=0.018). The dose of prednisone (<20 vs ≥20 mg) was not found to be significantly associated with surgery.

Upper GI Strictures

There were 24 patients (mean age 41, 50% female) with upper gastrointestinal strictures. There were 24 distinct strictures and 47 total dilations. Stricture locations were gastric (n=10), duodenal (n=9), and gastroduodenal (n=3). 91% of patients had de novo strictures, and 19% of patients had penetrating disease. 8/24 (33%) patients required surgery for CD-related stricture during the follow-up period. 6/24 (25%) patients had UGI located strictures; 4 located at the pylorus and 2 at the duodenum. 11/24 (46%) strictures required re-dilation.

The results of this study showed that 68% of patients who underwent EBD for treatment of CD related strictures did not require surgery within a five-year follow-up period. These findings align with existing literature, which demonstrated a 42.9% surgical rate following EBD, underscoring the utility of EBD in managing CD-related strictures with a low rate of surgical intervention post-EBD (11).

Treatment history at the time of diagnosis varied across patients, with some receiving anti-TNF, anti-integrin, IL-23 inhibitor, immunomodulators, or a combination thereof. Steroiduse at the time of dilation was also noted to provide insight into the pre-EBD treatment landscape as discussed below.

Consistent with previous studies, steroid therapy emerged as a predictor of poorer outcomes (11). The analysis revealed a significant association between the use of prednisone at the time of dilation and the subsequent need for surgical intervention within five years. Specifically, a higher proportion of patients who required surgery post-dilation (24.4%) were on prednisone compared to those who did not require surgery (11.6%). However, prednisone dosing (< 20 mg vs ≥ 20 mg) at the time of dilation was not significantly associated with surgery. Also, budesonide use at time of dilation was not associated with surgical intervention in the five-year timeframe. These findings suggest that prednisone use may be a predictor of poorer outcomes post-EBD, potentially due to its indication in more active, refractory disease, or perhaps due to its systemic effects that might influence stricture behavior or healing.

The type of stricture significantly impacted patient outcomes post-EBD. De novo strictures had a higher likelihood of leading to surgery compared to anastomotic strictures, a finding that has also been demonstrated in other studies (12). This finding emphasizes the importance of stricture etiology in guiding management and prognostication for CD patients undergoing EBD. Anastomotic strictures, perhaps due to their specific inflammatory and fibrotic pathways or their anatomical characteristics, may respond more favorably to EBD compared to de novo strictures (13). In addition, anastomotic strictures are more commonly a result of post-surgical complication compared to de novo strictures which result from active Crohn’s disease. This distinction between anastomotic and de novo strictures further highlights the importance of stricture etiology in guiding management decisions.

Our analysis included a significant number of total dilations, with strictures dilated to a maximal diameter based on the endoscopists’ judgment. Stricture characteristics such as location and severity were carefully evaluated, with the largest proportion being anastomotic and predominantly ileocecal. The need for repeat dilation was observed in 42.9% of the cases. This underscores the potential recurrent nature of CD-related strictures and highlights the necessity for ongoing surveillance and possibly iterative endoscopic interventions in managing this chronic condition. In addition, stepwise graded dilations are a safer approach for strictures with starting small diameters. Typically, we increase the diameter by 3 mm per session to prevent complications. The end goal is 18 mm for most of our endoscopists.

These findings offer valuable insights into the predictors of EBD success and the need for subsequent surgical intervention. Understanding these predictors can aid clinicians in selecting appropriate candidates for EBD and tailoring follow-up care to optimize patient outcomes. Further research may be needed to explore the mechanisms underlying these associations and to develop strategies to mitigate the risk of poor outcomes.

Data was mainly collected retrospectively via extraction from patient charts in the EMR which could contribute to potential information bias. This bias was mitigated through the uniform collection of data from consecutive patient files, so this potential bias was non-differential. In a small proportion of cases, there was no documentation of stricture length. Furthermore, this was a single center study, therefore limiting external validity. These potential confounders were controlled by multivariable adjustment. In addition, there were multiple endoscopists with no standard protocol for management of the strictures.

This is one of the largest single-center studies looking at EBD outcomes for treatment of CD-related strictures in individuals with IBD. This study also includes a long term follow up period. Future prospective studies should aim to validate these predictors and explore the impact of novel therapeutic strategies on EBD outcomes.

In summary, EBD represents an effective intervention for CD-related strictures, with specific patient and stricture characteristics predictive of outcomes. Identifying these predictors can guide clinicians in optimizing management strategies for individuals with CD, potentially reducing the need for surgical intervention.

Conflict of Interest:

None

Author Contribution

B.B. and M. I. wrote the majority of the main manuscript, collected data, and assisted in coordinating tasks. M. R. assisted in writing parts of the manuscript, data collection, and with table/figure preparation. A.B. analyzed the data and assisted in table/figure preparation for publication.M.B. was the main PI for this study and assisted in guiding, writing, and reviewing. All authors reviewed the manuscript.

Acknowledgements:

None

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Table 1. Patient characteristics and Montreal Classification of the disease at the time of stricture diagnosis

	All Patients (n=422)	Surgery post-dilation (n=135)	No surgery post-dilation (n=287)	p-value
Female, n (%)	225 (53.3)	79 (58.5)	146 (50.9)	0.14
Race, n (%)				0.09
Caucasian	397 (94.1)	128 (94.8)	269 (93.7)
African American	19 (4.5)	5 (3.7)	14 (4.9)
Age at dilation (years), mean (std)	45.2 (16.3)	45.1 (15.6)	45.2 (16.7)	0.94
BMI, mean (std)	26.6 (6.4)	26.2 (6.6)	26.8 (6.4)	0.40
Smoking Status, n (%)				0.59
Current	80 (19.1)	29 (21.5)	51 (17.9)
Never	244 (58.1)	74 (54.8)	170 (59.7)
Past	96 (22.9)	32 (23.7)	64 (22.5)
Age at Diagnosis				0.72
A1 (<16 years)	90 (21.7)	26 (19.4)	64 (22.9)
A2 (17-40 years)	235 (56.8)	79 (59)	156 (55.7)
A3 (>40 years)	89 (21.5)	29 (21.6)	60 (21.4)
Behavior of Disease, n (%)				0.0005
Stricturing	285 (68.5)	77 (57)	208 (74)
Stricturing and Penetrating	131 (31.5)	58 (43)	73 (26)
Location, n (%)				0.21
L1 (Ileal)	155 (37.3)	54 (40)	101 (35.9)
L2 (Colonic)	55 (13.2)	13 (9.6)	42 (14.9)
L3 (Ileocolonic)	199 (47.8)	65 (48.1)	134 (47.7)
L4 (Upper GI)	29 (7)	8 (5.6)	21 (7.5)
Perianal Disease, n (%)	133 (31.5)	53 (39.3)	80 (27.9)	0.02

Table 2. Treatment history at time of diagnosis along with stricture characteristics and response to endoscopic dilation

	All Patients (n=422)	Surgery post-dilation (n=135)	No surgery post-dilation (n=287)	p-value
Treatment at time stricture diagnosis, n (%)				0.45
Anti-TNF	110 (26.3)	38 (28.2)	72 (25.4)
Anti-integrin	34 (8.1)	12 (8.9)	22 (7.8)
Ustekinumab	26 (6.2)	5 (3.7)	21 (7.4)
Immunomodulators	46 (11)	16 (11.9)	30 (10.6)
Combo Therapy	57 (13.6)	23 (17)	34 (12)
Prednisone at dilation, n (%)	66 (15.7)	33 (24.4)	33 (11.6)	0.0007
Prednisone dose, mg <20 mg daily ≥20 mg daily	24/66 (36%) 42/66 (64%)	9 (28.13%) 23 (71.9%)	15 (44.1%) 19 (55.9%)	0.18
Budesonide at dilation, n (%)	28 (6.7)	12 (9)	16 (5.6)	0.20
Endoscopic Severity at time dilation, n (%)				0.14
Remission	56 (13.4)	16 (12.1)	40 (14)
Mild	126 (30.2)	37 (28)	89 (31.2)
Moderate	129 (31)	36 (27.3)	93 (32.6)
Severe	105 (25.2)	42 (31.8)	63 (22.1)
Location of Stricture, n (%)				0.21
Ileum	117 (27.9)	47 (34.8)	70 (24.7)
Ileocolonic	192 (45.8)	51 (37.8)	140 (49.3)
Colonic	54 (12.9)	18 (3.3)	36 (12.7)
Upper GI	24 (5.7)	7 (5.2)	17 (6)
Jejunal	7 (1.7)	3 (2.2)	4 (1.4)
Anal	24 (5.7)	9 (6.7)	15 (5.3)
Stricture type, n (%)				0.004
De Novo	245 (58.6)	92 (68.7)	153 (53.9)
Anastomotic	173 (41.4)	42 (31.3)	131 (46.1)
Need for redilation, n (%)	181 (42.9)	59 (43.7)	122 (42.5)	0.82
Stricture traversed, n (%)	341 (81.4)	104 (77.6)	237 (83.2)	0.17
Maximum dilation size				0.73
8-10 mm	36 (8.8)	14 (10.6)	22 (7.9)
11-14 mm	103 (25.1)	35 (26.5)	68 (24.5)
15-18 mm	225 (54.9)	68 (55.1)	157 (56.5)
>18 mm	46 (11.2)	15 (11.4)	31 (11.2)

Table 3. Demographics of individuals with upper GI strictures

	All Patients (n=24)	Surgery post-dilation (n=8)	No surgery post-dilation (n=16)	p-value
Female, n (%)	12 (50)	4 (50)	8 (50)	1
Age at dilation (years), mean (std)	41.5 (19.8)	37.6 (25.1)	43.1 (18.2)	0.62
BMI, mean (std)	24.2 (4.9)	21.5 (4.1)	25.6 (4.8)	0.05
Smoking Status, n (%)				0.37
Current	2 (8)	0	2 (13)
Never	20 (83)	8 (100)	12 (75)
Past	2 (8)	0	2 (13)
Age at Diagnosis, n (%)				0.83
A1 (<16 years)	5 (26)	2 (28)	3 (25)
A2 (17-40 years)	9 (47)	4 (57)	5 (42)
A3 (>40 years)	5 (26)	1 (14)	4 (33)
Behavior of Disease, n (%)				0.62
Stricturing	17 (81)	6 (75)	11 (85)
Stricturing and Penetrating	4 (19)	2 (25)	2 (15)
Prednisone at dilation, n (%)	5 (20.8)	1 (12.5)	4 (25)	0.63
Endoscopic Severity at time dilation, n (%)				0.36
Remission	2 (8)	1 (12.5)	1 (6)
Mild	5 (21)	0	5 (31)
Moderate	9 (38)	4 (50)	5 (31)
Severe	8 (33)	3 (37)	5 (31)
Stricture type, n (%)
De Novo	21 (91)	7 (100)	14 (88)
Anastomotic	2 (9)	0	2 (12)
Need for redilation, n (%)	11 (45.8)	4 (50)	7 (43.8)
Location of stricture, n (%)
Gastric	10 (38)	6 (40)	4 (60)
Duodenal	9 (35)	1 (11)	8 (89)
Gastroduodenal	3 (12)	1 (33)	3 (67)

No competing interests reported.

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You are reading this latest preprint version

Evaluating the Predictors of Endoscopic Balloon Dilation Failure, Success and Surgery Prevention in Crohn's Disease-related Strictures

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Abstract

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Brief Summary

Key Messages

Introduction

Materials and methods

Study Design

Population

Outcomes

Statistical Analysis

Results

Study Population Characteristics

Treatment Regimen and Endoscopic Characteristics at Dilation

Outcomes of Endoscopic Balloon Dilation

Upper GI Strictures

Discussion

Declarations

Conflict of Interest:

Author Contribution

Acknowledgements:

References

Tables

Additional Declarations

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