Introduction
Radiation therapy (RT) is indicated for treatment of various pelvic tumors and the
most frequent indications are prostate neoplasia, bladder cancer, gynecological malignancies,
and anorectal cancer [1]. Due to the rapid gut epithelial turnover and to the fixed position of the rectum,
pelvic RT is burdened by toxicity in the gastrointestinal tract, among which chronic
radiation proctitis (CRP), also referred as radiation-associated vascular ectasia
(RAVE), affected around 30 % of patients up until a few years ago [2]
[3]
[4]. Thanks to advances in conformal radiation, the delivery of more targeted external
beam radiation and, to a lesser extent, also to prophylactic measures, the incidence
of CRP has declined to 5 % to 20 %, although it remains a cumbersome RT complication
[5].
Rectal bleeding is the most frequent symptom of CRP [4]. Its management includes medical treatment, with topical drug administration, and
interventional treatment. Endoscopic therapy is a cornerstone of treatment for CRP-related
bleeding and relies on various techniques, such as argon plasma coagulation (APC),
radiofrequency ablation (RFA), cryotherapy, laser therapy and Heater probe and BiCAP
– contact therapy [6]. In two case reports, Mangiavillano et al. described a new treatment option for
controlling rectal bleeding from CRP, which was based on the rectal band ligation
(RBL) technique, but no other study of the technique has been published [7]
[8]. Endoscopic band ligation has already been used to treat lower gastrointestinal
bleeding from sources different from CRP, with good results [9]
[10]
[11].
Our belief is that RBL can be a valid further treatment modality for bleeding CRP,
particularly in patients who have extensive disease with recurrent hemorrhage.
The primary aim of this study was to evaluate clinical and technical success of this
new treatment for bleeding from CRP. The second aim was to evaluate the possible adverse
events (AEs) related to the procedure.
Patients and methods
Study population and data record
All included patients were treated in Humanitas – Mater Domini (Casellanza, Varese,
Italy) and Humanitas Research Hospital (Rozzano, Milan, Italy) for persistent bleeding
from CRP. After preoperative endoscopic assessment, we considered RBL in patients
who had telangiectasias on more than 50 % of the rectal circumference during luminal
insufflation. Demographic and anamnestic data were retrospectively analyzed, as well
as endoscopic aspects before and after RBL.
Rectal band ligation technique
All procedures were performed with the patient under conscious or deep sedation after
bowel preparation with enemas. After endoscopic evaluation, a multi-band ligator (6
Shooter Multi-Band Ligator, Cook Medical) was mounted on a standard gastroscope and
the bands were released until the visible rectal telangiectasias had been completely
obliterated, up to and including the entire circumference. Attention must be paid
after releasing the band because excessive insufflation can cause early slippage of
the band. Standard protocol after RBL included daily mesalamine enemas for 1 month.
Endoscopic control was planned between 2 and 3 months after the procedure, although
earlier evaluation was performed in case of relevant recurrent bleeding. Success was
defined as endoscopic evidence of complete rectal healing and/or cessation or significant
reduction in bleeding not requiring further treatment or blood transfusion. Technical
success was defined as the ability to place at least one band on the rectal area of
interest.
Results
We enrolled and retrospectively evaluated 10 patients, who were treated between February
2016 and February 2020. There were seven males (70 %) and mean age was 75.6 years.
Median follow-up was of 136.5 days (range 21–979 days). All male patients had received
local RT for prostate cancer. Of the remaining three women, one had been treated for
endometrial cancer and the other two for a rectal adenocarcinoma.
Eight patients (80 %) were naïve to endoscopic treatment, while in two patients (20 %),
APC had already been performed without any benefit.
Median length of affected rectum from the anal verge was 4.5 ± 3.12 cm (range 3–12 cm)
and mean surface area covered by telangiectasias was 89 % (range 50 %–100 %) ([Fig. 1]).
Fig. 1 Extensive hemorrhagic CRP with telangiectasias on about 75 % of the rectal circumference.
At least one band was released in every patient, with a technical success rate of
100 %. Clinical success was achieved in 100% of patients after a mean number of 1.8
± 0.8 RBL sessions (range 1–3) ([Fig. 2]). A mean number of 4.7 ± 2.0 bands were released in the first session while a mean
of 3.1 and 2 bands were placed in the second and third sessions, respectively. Only
one patient experienced an early AE: mild tenesmus and pelvic pain the day after the
procedure, with spontaneous resolution after 30 days of topical therapy with mesalamine
enema. Results are summarized in [Table 1].
Fig. 2 a Rectal band ligation technique on extensive CRP, which required placement of five
bands for achievement of complete obliteration of visible teleangectasia. b At 30-month reevaluation, the rectal mucosa was completely restored.
Table 1
Summary of results.
|
No. patients
|
|
Demographics
|
|
|
70 %
|
|
Mean age
|
75.6 yr
|
|
Median follow-up
|
136.5 d
|
|
RBL characteristics
|
|
|
20 %
|
|
Median CRP length
|
4.5 cm
|
|
Mean surface area involved
|
89 %
|
|
Mean RBL sessions
|
1.8
|
|
Technical success
|
100 %
|
|
Clinical success
|
100 %
|
|
Adverse events
|
1
|
RBL, rectal band ligation; CRP, chronic radiation proctitis.
Discussion
Pelvic radiotherapy is a fundamental step in treatment of pelvic tumors. Unfortunately,
the gut wall is particularly radiosensitive due to its high epithelial turnover, and
the fixed position of the rectum in the pelvis makes it prone to damage, with symptoms
of CRP occurring approximately 3 to 6 months after radiation exposure [12]. Persistent bleeding is typical, with concomitant complaints of tenesmus, urgency,
and fecal incontinence. To date, medical therapies and endoscopic interventions have
been the best treatment modalities for CRP [2]
[6]. In regard to endoscopic treatments, APC is usually the first-choice treatment modality
for CRP, although no consensus exists regarding the best APC settings. Reported success
rates for APC are between 70 % and 90 %, with at least two sessions in most of treated
patients [6]
[13]
[14]
[15]. However, if disease is extensive disease, more than two sessions may be required,
and the presence of telangiectasias on more than 50 % of the surface area has been
demonstrated to be related to APC failure [14].
Promising results have been reported with RFA, with clinical and endoscopic success
rates of 99 % and 100 %, respectively, and a mean number of 1.71 RFA sessions needed
to achieve response [16]. To date, use of a band ligator to treat acute lower gastrointestinal bleeding (ALGIB)
has been commonly reported in the setting of colonic diverticular bleeding and is
indicated as one of the first endoscopic treatment options [17]. The band ligation technique also has been used in other settings of ALGIB, such
as post-polypectomy bleeding and Dieulafoy’s lesion, with success rates around 93 %.
RBL has been used to treat rectal bleeding in patients with acute hemorrhagic rectal
ulcer, rectal varices, post-prostate biopsy bleeding, and rectal Dieulafoy’s lesion
[9]
[10]. De Robles et al. reported their experience with RBL as an often necessary complement
in management of hemorrhagic radiation proctitis with concomitant symptomatic hemorrhoids,
even though they released bands on hemorrhoids, unlike in the case of proctitis [11]. Mangiavillano et al. reported for the first time in literature, in two different
case reports, the possibility of using band ligation on patients with CRP who had
severe bleeding, with excellent results, although the disease was extensive [7]
[8]. The supposed mechanism of action of RBL should be comparable to band ligation in
esophageal varices. That is, induction of ischemic necrosis and superficial ulceration
as the main modifications in the trapped tissue, with extension of histological changes
limited to the mucosa and submucosa, and the intent of creating scar tissue to prevent
relapse of angiogenesis [18]. Our data show 100 % of technical and clinical success rates with use of RBL for
treatment of CRP with fewer endoscopic sessions (mean of 1.8) than with APC. RBL also
appears to be as effective as RFA, with a similar rate of success and number of endoscopic
sessions required. However, it is noteworthy that the HALO catheter for RFA is not
widely available and more expensive than an endoscopic band ligation system. Although
RFA is increasingly being used for a variety of gastrointestinal conditions, it is
primarily used in third-level centers for Barrett’s esophagus ablation [19]. In contrast, every interventional endoscopy unit owns a band ligator, thus making
RBL readily available. Apart from being effective, RBL is also safe because no serious
AEs have been reported with it, apart from tenesmus and pelvic pain in one patient,
which spontaneously improved. However, Pita et described a severe complication—development
of a rectourethral fistula, which occurred in a patient with a rectal ulcer who had
been treated for a hemorrhoid with elastic band ligation and had grade 1 CRP [20]. Although ulcers and fistula are counted as rare complications of CRP, this experience
should heighten awareness of possible AEs in patients who have frail irradiated mucosa.
RBL is distinguished from APC, which is associated with a 3 % to 40 % rate of AEs
including ulcerations, perforations, strictures, and fistulae [14]
[15]. The most common procedure-related complication with APC is rectal or anal pain,
with or without tenesmus, probably related to treatment too near the dentate line.
Coriat et al. proposed to use a transparent distal attachment to improve visualization
of the distal part of the rectum to ensure a proper distance for safe APC application
[21]. The natural presence of the transparent cap on the ligator set helps overcome this
problem. Moreover, RBL does not require particular endoscopic skills or involve a
learning curve and is applicable in all endoscopic centers.
This study has some strengths. It described a novel, cheap, safe, and widely available
technique for treating a common disease. Its limitations can be ascribed to the retrospective
design and the small sample analyzed. Further studies are needed to confirm the efficacy
of RBL, for treatment of bleeding and for other CRP-related symptoms, because APC
also has been proven to improve tenesmus, diarrhea, and urgency in up to 75 % of patients.
An additional suggestion for future studies could be to use an endoscopic severity
score to grade CRP so that results are comparable [22]. To our knowledge, ours is the first study reporting on the use of RBL for treatment
of CRP.
Conclusions
In conclusion, RBL could be a valid, cheap, and easily performed alternative for treatment
of persistent bleeding from CRP, particularly in patients who have wide disease extension,
with a very low rate of AEs and no need for particular operator skills.
