Keywords
Endoscopy Lower GI Tract - Inflammatory bowel disease - Endoscopy Small Bowel
Introduction
Stricture disease is a common manifestation of inflammatory bowel disease (IBD), particularly
in Crohn’s disease (CD) patients[1]. Ileal pouch-anal anastomosis (IPAA) is a common surgery performed for treatment
of refractory ulcerative colitis (UC), familial adenomatous polyposis (FAP), and select
cases of Crohn’s colitis. Strictures of the ileal pouch and pouch anastomosis may
be primary or secondary to the surgery. The treatment of anorectal and anopouch strictures
are particularly challenging, and historically focused on surgical resection and/or
diversion[2]. Other treatment options include digital[3], balloon[4], or bougie [5] dilatation, stenting[6], and corticosteroid injection[7]. Many patients require repeated interventions.
Endoscopic balloon dilation (EBD) has been shown to be safe and effective in treating
ileal pouch strictures[8], primary and anastomotic CD strictures [9]
[10]. However, EBD can be ineffective for particularly tight and long strictures. Approximately
25% of patients will require surgery within 3 to 4 years following EBD treatment [11].
Endoscopic electroincision therapy involves the disruption of fibrosed and/or strictured
tissue with controlled electrocautery. Endoscopic electroincision therapy has been
described as a treatment option for esophageal and upper gastrointestinal disease,
but its use in colorectal disease remains uncharted. A case series by Truong et al.
explored the use of combined endoscopic electroincision therapy and balloon dilatation
for treatment of benign colorectal anastomotic strictures in 35 patients [12]. Clinical data on the use of endoscopic electroincision to treat strictures related
to CD is also scarce. A single case report from Korea described the successful use
of an endoscopic insulated-tip knife to treat a CD-related anorectal stricture [13].
Shen et al. first described the novel needle-knife stricturotomy technique to treat
ileal pouch strictures[14] and subsequently proved that it is a safe and effective alternative to surgery for
a variety of refractory CD-related strictures (including ileal pouch anastomosis,
pouch inlet/afferent limb, and anal strictures) [15]. Endoscopic stricturotomy has been favorably compared with EBD for the treatment
of pouch inlet/afferent limb strictures[16]. Endoscopic stricturotomy results in comparable surgery-free survival time as compared
with surgical resection for treatment of ileocolonic anastomotic strictures, with
the additional benefit of reduced morbidity [17].
Ongoing research on the effectiveness of this technique in treating anorectal/anopouch
strictures, and specifically its most severe type (endoscopically non-traversable),
are important and necessary as these strictures often preclude patients from definitive
surgical intervention for more proximal disease. This study aimed to evaluate the
technical success and post-procedure outcomes of endoscopic insulated-tip (IT)/needle-knife
(NK) stricturotomy in treating severe, endoscopically non-traversable anorectal and
anopouch strictures at our tertiary-care center.
Patients and methods
Data sources
This study was approved by the Columbia University Irving Medical Center Institutional
Review Board (IRB). At the Interventional IBD Center at Columbia University Irving
Medical Center, endoscopic electroincision with stricturotomy has become the first
and standard therapy for patients with anorectal/anopouch strictures since December
2019. In clinical practice, we have noticed a better efficacy of endoscopic stricturotomy
than EBD. More importantly, stricturotomy with electroincision in a circumferential
fashion may avoid iatrogenic trauma to anal sphincters from radial tears of EBD.
All consecutive patients with anorectal or anopouch strictures treated with endoscopic
stricturotomy at our IBD Center between January 2020 and March 2022 were identified
from our institution’s IBD registry. Demographic and clinical data, endoscopic procedural
data, and post-procedure outcomes data were reviewed from the medical records.
Inclusion and exclusion criteria
Inclusion criteria included any patient with an endoscopically non-traversable anorectal
or anopouch stricture that was treated by IT/NK endoscopic stricturotomy with or without
prior endoscopic or other intervention (i.e., EBD). Patients who did not meet the
above criteria or lacked complete clinical documentation or follow-up information
were excluded from the study.
Endoscopic stricturotomy procedure
Every patient had a visit with the gastroenterologist prior to endoscopy, during which
a complete medical and surgical history was obtained and physical exam performed.
Endoscopy and/or imaging was used to diagnosis a stricture prior to planned stricturotomy
intervention. The decision to treat a stricture with IT/NK stricturotomy was based
solely on the clinical judgment of the patient’s gastroenterologist. All IT/NK stricturotomy
procedures were performed by the senior author, an experienced interventional endoscopist.
All patients without diverting ostomies received oral polyethylene glycol-based bowel
preparation the day prior to their planned procedure. The procedure was performed
under conscious sedation or monitored anesthesia care in an outpatient setting.
The procedure begins with a thorough examination and any perianal/anal abnormalities
are documented. An upper endoscope (GIF series, Olympus, Tokyo) is then advanced to
the level of the stricture. This study included only strictures noted to classified
as either anorectal (anorectal ring) or anopouch. The degree of stricture is then
noted (classification 0–4) [15]. The estimated length of the stricture is noted. Soft-tip guidewire was used in
selected patients with pinhole strictures or adjacent fistulae. The IT ([Fig. 1]), IT2 (Olympus, Tokyo), NK ([Fig. 2]) (Boston Scientific, 300 Boston Scientific Way Marlborough, Massachusetts, United
States) and Erbe VIO 300 D electrosurgical generator (ERBE USA, Marietta, Georgia,
United States) with a setting of Endocut mode were used to perform electroincision
and/or electrocautery treatment. The Endocut mode on the Erbe electrosurgical generator
combines both cutting and coagulating, in short bursts. The ability to traverse the
prior stricture site was tested immediately following treatment. Post-procedure patients
were observed 30–45 minutes in the recovery room before discharge home.
Fig. 1 Endoscope reintervention-free survival.
Fig. 2 Surgery reintervention-free survival.
Endoscopic reintervention
All patients who underwent endoscopic stricturotomy intervention were seen in the
office for follow-up visits. Success of intervention was marked by documentation of
symptom improvement or relief – namely reduced or resolved pain and improved bowel
function. Return or worsening of symptoms prompted reevaluation. Endoscopy was performed
to evaluate and define the character of the stricture. The decision to perform repeat
IT/NK stricturotomy was made by the senior author.
Data collection
Patient demographic information was collected, including age, sex, race/ethnicity,
body mass index (BMI), smoking status, primary diagnosis, and medical comorbidity
history. Smoking status was designated as either active smoker or non-active smoker.
Primary diagnosis represented the patient’s IBD diagnosis of either CD or UC. Two
patients included in the study had a primary diagnosis of colonic neoplasm or FAP.
Active IBD-related medications, including biologics and corticosteroids, were documented.
Procedural details and stricture data was obtained from the medical record, as well
patient follow-up data which was recorded as per the usual clinical practice. The
need for reintervention, whether endoscopic or surgical, was noted through procedural
notes documented in the medical record, which was reviewed over the course of the
study period.
Outcomes
The primary outcome was immediate technical success, as measured by the ability to
traverse the strictured site with the endoscope [18]. Secondary outcomes were procedure-associated adverse events (AEs) (both 30-day
post-procedure and the individual complete post-procedure follow-up times), as well
as endoscopy reintervention-free survival and surgery-free survival[18]. Post-procedure follow-up time was defined as the time from the index endoscopic
IT/NK stricturotomy to the end of the study period.
Statistical analysis
Descriptive statistics were performed for all appropriate variables. Categorical variables
were reported as percentages, while quantitative variables were reported as mean ±standard
deviations. Repeat endoscopy-free and surgery-free survival were evaluated with Kaplan-Meier
curves.
Results
A total of 24 patients met the criteria for inclusion in the study. All patient and
stricture characteristics are listed in [Table 1].
Table 1 Patient and stricture characteristics (N=24).
|
Patient characteristics, n (%)
|
|
|
SD, standard deviation; ASA, American Society of Anesthesiologists.
|
|
Age, years, mean ±SD
|
39.4 ± 14.5
|
|
Female gender, n (%)
|
16 (66.7)
|
|
Race/ethnicity, n (%)
|
|
|
14 (58.3)
|
|
|
10 (41.7)
|
|
ASA class, n (%)
|
|
|
18 (75)
|
|
|
6 (25)
|
|
Body mass index, kg/mm2, mean (SD)
|
23.9 (5.4)
|
|
Non-active smoker, n (%)
|
24 (100)
|
|
Primary diagnosis, n (%)
|
|
|
18 (75)
|
|
|
4 (17)
|
|
|
1 (4)
|
|
|
1 (4)
|
|
Active medications, n (%)
|
|
|
|
|
2 (8)
|
|
|
4 (16)
|
|
|
7 (29)
|
|
|
3 (12.5)
|
|
|
|
|
2 (8)
|
|
|
2 (8)
|
|
|
|
|
3 (12.5)
|
|
|
1 (4)
|
|
Characterization of strictures
|
|
|
|
|
17 (71)
|
|
|
7 (29)
|
|
|
24 (100%)
|
|
|
2.4 ± 1.2
|
Demographic and clinical data
The mean age was 39.4±12.4 years, and the majority of patients were female (66.7%)
and White (58.3%). The mean BMI was 23.9 ± 5.4, and nearly all patients were American
Society of Anesthesiologists Class 1 and 2 (75%). All patients aside from two had
a primary diagnosis of CD (75%) or UC (17%). Most patients (71%) were actively receiving
biological agents, glucocorticoids, or an anti-metabolite as a part of their treatment
plans.
Characteristics of strictures
The majority of strictures were anorectal in type (71%). The mean stricture length
was 2.4 (± 1.2 cm), which is considered short (< 4 cm). 3 patients (12.5%) had documented
history of EBD for the treatment of the stricture prior to the initial IT/NK stricturotomy.
The decision to perform EBD prior to stricturotomy therapy was based on stricture
type and clinical judgment of the primary gastroenterologist.
Outcomes
The results of endoscopic IT/NK stricturotomy intervention are listed in [Table 2]. All patients achieved immediate technical success with documented traversability
by the endoscope. There were no 30-day post-procedure AEs that required readmission
or intervention. We highlighted common complications including perforation, ileus,
and bleeding. There were no significant AEs for any patients over the entirety of
the post-procedure follow-up period.
Table 2 Procedure outcomes (N = 24).
|
Immediate technical success, n (100%)
|
24 (100)
|
|
Reintervention, n (%)
|
|
|
16 (66.6)
|
|
|
2 (8.3)
|
|
|
1
|
|
|
1
|
|
|
1 (4.2)
|
|
|
7 (29)
|
|
Time to reintervention, months ± mean SD
|
5.3 ± 4.0
|
|
Follow-up time, months, mean ± SD
|
12.8 ± 6.4
|
|
30-day post-procedure complications, n (%)
|
|
|
0 (0)
|
|
|
0 (0)
|
|
|
0 (0)
|
|
Post-procedure adverse events (total follow-up period), n (%)
|
0 (0)
|
|
IT, insulated tip; NK, needle knife; SD, standard deviation
|
|
Repeat endoscopic IT/NK stricturotomy intervention was required for 67% of patients,
but only two patients (11%) required surgical intervention following initial IT/NK
stricturotomy. The mean time to reintervention was 5.3 ± 4.0 months. One patient required
a completion proctectomy and end ileostomy creation for a rectovaginal fistula with
associated abscesses. The other patient ultimately required takedown of the coloanal
anastomosis and end colostomy creation due to the severity of disease. Seven patients
(29%) did not require any reintervention after initial IT/NK stricturotomy therapy.
The mean follow-up time was 12.8 ± 6.4 months. The interval between the index endoscopic
intervention and the first endoscopic reintervention and/or first surgical interventions
were calculated for survival curves. Kaplan-Meier analysis was performed to evaluate
repeat endoscopic intervention-free survival ([Fig. 3]) Cumulative endoscopic reintervention-free survival was 33%. Kaplan-Meier analysis
was performed to evaluate surgery-free survival. ([Fig. 4]) Cumulative surgery-free survival was 92% during the follow-up period.
Fig. 3 Insulated-tip endoscopic stricturotomy.
Fig. 4 Needle-knife endoscopic stricturotomy.
Discussion
Our study evaluated 24 patients with non-traversable anorectal/anopouch strictures
of various etiologies treated with endoscopic IT/NK stricturotomy. All patients achieved
immediate technical success without any post-procedure AEs. A substantial number of
patients required repeat endoscopic intervention, but the majority of patients were
able to avoid surgical intervention.
Anorectal strictures represent some of the most challenging manifestations of IBD,
and anopouch strictures represent a serious complication for patients who undergo
IPAA surgery. A case series of CD patients reported a prevalence of 8.9% for anorectal
stricture disease [19] and so this represents a common problem for IBD patients and their clinicians. Strictures
are defined by etiology type (primary vs anastomotic), length (long vs short), number,
degree of fibrosis and inflammation, and presence of concurrent fistulae/abscess.
These characteristics are meant to assist in treatment planning, however, optimal
treatment for such strictures is not clearly defined in either the medical or surgical
literature. There are no prospective studies examining the management of anorectal
strictures [20] and the role of medical therapy in the treatment of anorectal or anopouch strictures
has not been well defined.
Interventional endoscopy has expanded to position itself as a bridge between medical
therapy and surgical intervention. Endoscopic therapies for strictures include EBD,
stent placement, intralesional injection, and stricturotomy. Among the endoscopic
options, EBD is the most studied. The Global Interventional IBD Group, consisting
of IBD experts and specialists, published formal position statements on the role of
these endoscopic interventions [21]. They outlined the safety of EBD for primary and secondary strictures, although
acknowledged that achieving clinical success with this method was unlikely and that
repeat EBD is often necessary. Endoscopic stenting with covered removable metal stents
were shown to be less effective and is more complication-prone than EBD in a recent
randomized controlled trial (RCT) [22].
Endoscopic stricturotomy was first described to be safe and effective for the treatment
of ileal pouch strictures and various other IBD-related fibrotic strictures [14]
[15]. Endoscopic stricturotomy is more technically demanding than EBD but is associated
with a higher rate of technical success and reduced rate of subsequent surgery than
EBD for treatment of CD-related anastomotic strictures (included in this cohort were
six ileo-rectal anastomotic strictures)[9]. However, endoscopic stricturotomy does carry a higher risk of bleeding than EBD.
Bleeding associated with endoscopic stricturotomy in the anorectal area can usually
be readily managed with topical tamponade.
The Global Interventional IBD Group noted that stricturotomy may be the ideal treatment
modality for Crohn’s-related distal bowel or anal strictures. Endoscopic stricturotomy
offers control over the location, depth, and orientation of electroincision, avoiding
inadvertent injury to the anal sphincter or anorectal fistula formation. Our study
supports this notion by demonstrating the safety of the IT/NK endoscopic stricturotomy
technique in treating severe anorectal/anopouch strictures. It also affirms the efficacy
of this treatment modality in achieving technical success, as well clinical success
by preventing or delaying the need for surgical intervention. Our study reported a
surgical intervention rate of 11% over a mean follow-up period of 11 months, as compared
with a rate of 27% over a median follow-up period of 15 to 70 months in a meta-analysis
of EBD treatment of CD-related strictures [23]. This is also comparable to a previous study of various IBD-related strictures treated
with endoscopic stricturotomy that reported a 15.3% rate of subsequent surgery over
a follow-up of 0.9 years[9]. Only three of our patients underwent EBD prior to IT/NK stricturotomy, so these
results should not be attributed to a combined effect of EBD+IT/NK Stricturotomy.
This study has limitations in its generalizability, as the IT/NK stricturotomy was
performed by an experienced endoscopist with the skilled support staff at a tertiary-care
center. This may also contribute to a selection bias. In addition, the sample size
is small and follow-up time was relatively short. We aim to gather more data with
a larger sample size in follow-up studies, and those will likely include treatment
comparison outcomes. Anorectal ring strictures in patients with IBD are newly recognized
disease entities and there is scant literature on endoscopic therapy. There have been
concerns about the iatrogenic injury to anal sphincters with previously published
size of balloons (18–20 mm). However, the authors are exploring drug-coated balloons
for the treatment of refractory anorectal and lower GI strictures. In fact, our Columbia
University team is leading the Patent B trial (NCT03885310). It will be interesting
to compare the safety and efficacy of endoscopic stricturotomy and drug-coated balloons
in the treatment anorectal and anopouch strictures.
The majority of the patients in this series required endoscopic reintervention although
almost all of them avoided surgery during the follow-up. Clinically, the management
of anorectal strictures has been challenging. Various non-surgical options have been
explored, including EBD (with radial force) and bougie (with shear force) dilation.
The recurrence of strictures after non-surgical treatment is common and most patients
required frequent treatment. On the other hand, surgical therapy including completion
proctocolectomy, completion proctectomy, pouch excision with permanent fecal diversion
is not a valid option for most patients. Morbidities following “more definitive” surgical
therapy include stoma complication, persistent perineal sinus (especially in those
with current perianal fistula), and iatrogenic injuries to pelvic organs. Therefore,
we believe that endoscopic stricturotomy remains a valid treatment option for those
with refractory anorectal strictures before more effective and safer treatment modalities
are available.
Conclusions
In conclusion, IT/NK endoscopic stricturotomy is safe and effective in the treatment
of primary and secondary severe (non-traversable) and short (< 4 cm) anorectal or
anopouch strictures, when performed by an experienced interventional endoscopist.
We recommend its consideration in the treatment plan for patients with such strictures.
The emphasis on advanced endoscopic training during gastroenterology/IBD fellowship
is essential so that this technique may become more widely available for further use
and study. Ongoing clinical research with larger sample sizes and longer follow-up
time is necessary, as well as prospective and RCTs evaluating endoscopic stricturotomy
vs EBD or surgical treatment are crucial.
Insulated tip/needle-knife endoscopic stricturotomy is safe and effective
for treatment of non-traversable anorectal stricture
Koby Herman, Ravi P.
Kiran, Bo Shen Endoscopy International Open 2024; 12: E231–E236. DOI:
10.1055/a-2230-7372
In the above-mentioned article an authorʼs correspondence address
was corrected. This was corrected in the online version on 26.02.2024.
