ORIGINAL ARTICLE: Clinical Endoscopy

Colonic-enteric lumen-apposing metal stents: a promising and

safe alternative for endoscopic management of small-bowel
obstruction
Shuji Mitsuhashi, MBBS,1 Faisal Kamal, MD,2 Brianna J. Shinn, MD,2 Divya Chalikonda, MD,2
Amy Tyberg, MD,3 Haroon Shahid, MD,3 Avik Sarkar, MD,3 Michel Kahaleh, MD,3 Austin Chiang, MD,2
Anand Kumar, MD,2 Alex Schlachterman, MD,2 David Loren, MD,2 Thomas Kowalski, MD2

Philadelphia, Pennsylvania; New Brunswick, New Jersey, USA

GRAPHICAL ABSTRACT

Background and Aims: Lumen-apposing metal stents (LAMSs) have revolutionized the treatment of various gas-
troenterologic conditions that previously required surgery. The use of LAMSs for the management of small-bowel
obstruction (SBO) involves EUS-guided coloenterostomy (EUS-CE) between the colon and a dilated loop of the
small intestine proximal to the point of obstruction. This procedure is potentially beneficial for patients with ma-
lignant SBO who are poor surgical candidates.
Methods: A retrospective cohort study was conducted at 2 tertiary care hospitals. Patients who underwent EUS-
CE for SBO were identified, and data regarding patient demographics, indication for the procedure, location of
the obstruction, procedural details, and adverse events were collected. The primary outcome was technical suc-
cess of the procedure. Secondary outcomes were clinical success, resolution of symptoms, ability to tolerate
enteral nutrition, and adverse events.
Results: Twenty-six patients who underwent the EUS-CE procedure were included. Technical success was
achieved in all 26 patients, clinical success (resolution of obstructive symptoms) was achieved in 92.3% of patients
(24/26), and the ability to resume enteral nutrition in 84.6% (22/26). Adverse events occurred in 4 patients (15.4%)
and included bleeding (1/26), diarrhea (2/26), and postprocedure sepsis (1/26). Patients were followed for a mean
of 54.8 days (range, 2-190).
Conclusions: This study highlights that EUS-CE with LAMSs can be performed with high technical and clinical
success for the management of SBO, particularly in patients with malignant obstructions who are not suitable can-
didates for surgical interventions. Further research with larger sample sizes will be essential to substantiate its ef-
ficacy and safety. (Gastrointest Endosc 2024;99:606-13.)

(footnotes appear on last page of article)

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Mitsuhashi et al
Small-bowel obstruction (SBO) is a well-recognized adverse
event frequently seen in malignancies with peritoneal or small-
bowel involvement. The reported incidence of SBO ranges
from 10% to 28% in GI malignancies with higher rates
observed for gynecologic cancers.1,2 Malignant SBO is associ-
ated with severe pain, anorexia, nausea, and vomiting. Manag-
ing SBO poses a significant challenge for oncologic and
palliative care services, often indicating a sentinel preterminal
event.3 In cases where patients are not suitable for surgical
intervention, the management of malignant SBO is typically
limited to pain management, parenteral nutrition, and sup-
portive care.4 A venting PEG tube that is frequently used in
these patients releases built-up pressure to reduce vomiting
and pain. The venting PEG tube, however, is associated with
psychological, emotional, physical, and clinical drawbacks of
maintaining an external tube without providing nutrition.5
Lumen-apposing metal stents (LAMSs) have revolution-
ized the endoscopic treatment of various gastroenterologic
conditions, extending beyond their original approval for
pancreatic fluid collections. LAMSs have gained popularity
for managing benign and malignant gastric outlet obstruc-
tion using EUS-guided gastroenterostomy,6-9 which has
emerged as a viable option exhibiting comparable efficacy
and safety to surgical gastrojejunostomy.10-12 EUS-guided
coloenterostomy (EUS-CE) with a LAMS between the colon
and a dilated loop of the small intestine proximal to the
point of obstruction can relieve the obstruction in the
distal small bowel and is a potential therapeutic option in
these patients who are not surgical candidates.
Although EUS-CE has potential benefits, large case series
to validate the efficacy and safety of this procedure are lack-
ing. One recent case series evaluated 10 cases of EUS-CE, but
the small sample size limited generalizability.11 Here we
report a larger cohort of patients who underwent EUS-CE
for SBO from 2 U.S. tertiary care hospitals.
METHODS
Study design
Between June 2014 and April 2023, an institutional review
board–approved retrospective cohort study was performed
across 2 tertiary referral medical centers (Thomas Jefferson
University Hospital, Philadelphia, Pa, USA, and Robert Wood
Johnson University Hospital, New Brunswick, NJ, USA). The
database was queried to identify patients who were hospital-
ized with SBO and underwent EUS-CE with LAMS placement.
LAMSs were either 15  10 mm or 20  10 mm AXIOS stents
(Boston Scientific, Marlborough, Mass, USA) loaded on an
electrocautery-enhanced delivery system. Data were collected
through the hospital electrical medical record including both
EPIC (Epic Systems Corporation, Verona, Wisc, USA) and
gGastro (ModMed, Boca Raton, Fla, USA).
Procedure technique
All procedures were performed with patients under gen-
eral anesthesia. Periprocedural broad-spectrum intrave-
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Colonic-enteric lumen-apposing metal stents
nous antibiotics were administered to provide coverage
for anaerobic and gram-negative bacteria.
For the coloenteric approach, a forward-viewing scope
such as a therapeutic endoscope, gastroscope, or adult or pe-
diatric colonoscope (Olympus, Center Valley, Pa, USA) was
advanced through the rectum. If a wire-guided approach
was used, a long guidewire (.035 or .025 inches) was advanced
through the scope. The endoscope was removed and re-
placed with a therapeutic linear echoendoscope, which was
navigated through the colon using fluoroscopic guidance.
In some cases, an overtube (Pathfinder, Neptune Medical,
Burlingame, Calif, USA) was initially advanced over the
forward-viewing scope, and then an EUS scope was advanced
through the overtube. A dilated bowel loop was identified by
EUS (Fig. 1A). In some cases, a 19-gauge needle was used to
puncture and inject contrast to confirm correct positioning
within the target small-bowel loop. Next, a cautery-
enhanced LAMS was deployed under EUS and fluoroscopic
guidance (Fig. 1B), creating an anastomosis between the co-
lon and small bowel. The LAMS was dilated with a dilation
balloon (Fig. 1C) and correct placement confirmed by endo-
scopic visualization of the small-bowel mucosa (Fig. 1D).
Fluoroscopy was used to assess for extraluminal air.
For the enterocolonic approach, the procedure involved
an assessment of cross-sectional imaging to determine the
section of colon with the largest diameter. The echoendo-
scope was advanced as deeply as possible into the small
bowel. After puncturing a dilated colonic segment and in-
jecting contrast to confirm the location in the colon, the
LAMS was deployed using the previously described tech-
nique for an EUS-guided gastroenterostomy, typically per-
formed freehand.
Data collection
Data collection included several variables that were
divided into 3 main categories: demographic data, clinical
data, and procedural data. Demographic data consisted of
age and sex. Clinical variables were the reason for the proced-
ure, presence of malignancy and related adverse events, past
abdominal surgeries, symptoms and their duration, alterna-
tive treatment methods used, and use of nonoral nutritional
delivery. Past abdominal surgeries encompassed procedures
such as Whipple (classic and pylorus-preserving), Roux-en-Y
hepaticojejunostomy, Roux-en-Y gastric bypass, duodenal
switch, small-bowel resection, colonic resection, surgical de-
bulking, gastric resection, and esophagectomy. Symptoms of
SBO were classified into 4 categories: feeding intolerance
alone, distension and abdominal pain alone, nausea and
vomiting alone, and multiple symptoms. The duration of
symptoms was categorized as less than 2 weeks, 2 to 4 weeks,
and over 4 weeks. Alternative decompression methods
before LAMS placement were use of a nasogastric tube, naso-
jejunal tube, stricture dilation, enteral stent, venting PEG or
jejunostomy tube, and surgical debulking. Procedural data
were information on the location of the obstruction, route
and site of deployment, technical method, and type of
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Colonic-enteric lumen-apposing metal stents Mitsuhashi et al

Figure 1. EUS-guided coloenterostomy with lumen-apposing metal stent (LAMS) placement. A, Dilated loop of the small bowel shown with EUS. B, Fluo-
roscope image demonstrating appropriate positioning of a 20  10-mm LAMS between the small intestine and colon. C, Endoscopic image of balloon
dilation after LAMS placement. D, Confirmation of LAMS placement endoscopically by direct visualization.

devices used including the use of an overtube, LAMS diam-
eter, and balloon dilation.
Outcome measures
Data related to the postprocedure course were collected,
which included time until clinical success, occurrence of
recurrent obstruction, and number of days of follow-up after
discharge. Technical success was characterized as the suc-
cessful deployment of a LAMS between the colon and a
dilated loop of the small bowel proximal to the site of the
obstruction. Clinical success was defined as the resolution
of the SBO after the procedure, which was confirmed by
resolution of symptoms, passage of bowel movements,
and ability to remove the nasogastric or nasojejunal tube
if present. Major adverse events were defined as any of
the following occurrences during or after the procedure:
maldeployment including deployment into a nontargeted
destination, bleeding, perforation, diarrhea, or postproce-
dural sepsis. The severity of adverse events was categorized
according to American Society for Gastrointestinal Endos-
copy lexicon.13 Mortality was categorized into procedure-
related and progressive cancer or comfort care/hospice.
RESULTS
Baseline characteristics
Twenty-six patients underwent EUS-CE with LAMS place-
ment for SBO during the study period. Table 1 highlights de-
mographic and clinical data of the study group, which
comprised 56.5% women and with a mean patient age of
66.2 years (range, 26-89). Among the patients, 22 (84.6%)
received the procedure while an inpatient and 25 (96.1%)
had a malignant etiology. Of patients with malignancy, 18
had peritoneal or omental metastases and 24 were undergo-
ing concomitant chemotherapy. Sixteen patients (61.5%)

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Mitsuhashi et al Colonic-enteric lumen-apposing metal stents

TABLE 1. Baseline demographic and clinical characteristics of patients undergoing EUS-guided coloenterostomy (n [ 26)

Variables Values

Demographic data
Mean age, y (range) 66.8 (26-89)
Sex
Male 12 (46.2)
Female 14 (53.8)
Clinical data
Patient status
Inpatient 22 (84.6)
Outpatient 4 (15.4)
Indication for procedure
Benign 1 (3.9)
Malignant 25 (96.1)
Evidence of peritoneal/omental metastases 18
Chemotherapy given 24
Presence of ascites 16 (61.5)
Prior intestinal surgery
Duodenal switch 1 (3.9)
Small-bowel resection 4 (15.4)
Colonic resection 11 (42.3)
Surgical debulking 5 (19.2)
Symptoms
Distension/pain only 17 (65.4)
Nausea and vomiting only 3 (11.5)
Multiple symptoms 6 (23.1)
Symptom duration
<2 wk 4 (15.4)
2-4 wk 11 (42.3)
>4 wk 11 (42.3)
Prior decompression modalities attempted
Nasogastric or nasojejunal tube 13 (50.0)
Enteral stent 3 (11.5)
Venting PEG or jejunostomy tube 7 (26.9)
Surgical debulking 3 (11.5)
Nonoral nutritional delivery
Tube feeding 7 (26.9)
Parental nutrition 12 (46.2)
Values are n (%) or n unless otherwise defined.

had evidence of ascites on imaging. Twenty-one pati-
ents (80.8%) had undergone previous intestinal surgery
including duodenal switch, small-bowel resection, colonic
resection, and surgical debulking. Abdominal distension
and pain alone were the most common symptoms, reported
by 17 patients (65.4%). Before the EUS-CE procedure, all 26
patients had previously undergone various methods of
enteral decompression, including the use of nasogastric or
nasojejunal tubes in 13 patients (50%), enteral stent place-
ment in 3 patients (11.5%), venting PEG or jejunostomy
tube in 7 patients (26.9%), and surgical debulking in 3
patients (11.5%). Regarding nutrition, 7 patients (26.9%)
were receiving tube feeding, whereas 12 patients (46.2%)
were receiving parenteral nutrition.
Procedural characteristics and outcomes
The site of obstruction was predominantly located in the
small intestines (76.9%) in our study and, in a few cases, the

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Colonic-enteric lumen-apposing metal stents Mitsuhashi et al

TABLE 2. Procedural characteristics of EUS-guided coloenterostomy

Procedural characteristics Values

Location of obstruction, n (%)

Small intestine 20 (76.9)
Colon 6 (23.1)
Mean bowel loop diameter before LAMS insertion, mm (range) 37.2 (18-57)
Route of deployment
Colonoenteric 20 (76.9)
Enterocolonic 6 (23.1)
Colonic segment of deployment
Sigmoid 13 (50.0)
Descending 7 (26.9)
Transverse 4 (15.4)
Ascending 2 (7.7)
Estimated site of deployment
Duodenum 0 (0)
Jejunum 7 (26.9)
Ileum 9 (46.2)
No record 7 (26.9)
Overtube used 4 (15.4)
Technique
Freehand 19 (73.1)
Wire-guided 7 (26.9)
Additional fluid added to distend target lumen 14 (53.9)
LAMS diameter
15 mm 6 (23.1)
20 mm 20 (76.9)
Balloon dilation after LAMS placement 26 (100)
Values are n (%) unless otherwise defined.
LAMS, Lumen-apposing metal stent.

colon (23.1%) (Table 2). The initial bowel-loop diameter
before the insertion of LAMSs averaged 37.2 mm, ranging
from a minimum of 18 mm to a maximum of 57 mm. The
route of deployment was either enterocolonic (23.1%) or co-
loenteric (76.9%). Thirteen cases (50%) were entered
through the sigmoid colon, 7 (26.9%) through the descend-
ing colon, 4 (15.4%) through the transverse colon, and 2
(7.7%) through the ascending colon. An overtube was
used in 4 cases (15.4%). LAMS placement over a guidewire
was done in 7 cases (26.9%), and 14 cases (53.9%) required
the injection of fluid to distend the target enteric lumen. A
20-mm LAMS was placed in 20 cases (76.9%) and a 15-mm
LAMS in 6 cases (23.1%), all of which were dilated with a
balloon after deployment.
As shown in Table 3, technical success was achieved in all
cases. Clinical success was achieved in 92.3% of patients (24/
26), with symptoms resolving at a mean of 6.0  5.5 days
(range, 1-24) after the procedure. Twenty-two patients
(84.6%) were able to tolerate oral intake. Four patients
(15.4%) developed recurrent obstruction after the proced-
ure, but none occurred at the same site. Adverse events
included bleeding in 1 patient (3.9%), diarrhea in 2 patients
(7.7%), and postprocedural sepsis in 1 patient (3.9%).
Following the guidelines of the American Society for Gastro-
intestinal Endoscopy lexicon, 3 patients (11.5%) experienced
mild adverse events and 1 patient (3.8%) moderate adverse
events. Two patients (7.7%) died during follow-up at post-
procedure days 5 and 14, respectively, both of which were
attributed to the progression of cancer and were not related
to the procedure. Patients were followed for an average of
54.8  43.8 days (range, 2-190) after the procedure.
DISCUSSION
EUS-CE provides an opportunity for minimally invasive
treatment of complex small-bowel disorders that cannot be
managed with surgery or other methods, including an inter-
ventional radiologic approach, because of patient-specific
factors or anatomic limitations. Although some case reports

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Mitsuhashi et al
TABLE 3. Postprocedural clinical outcomes of EUS-guided coloenterostomy
Procedural outcomes
Technical success
Clinical success
Resolution of symptoms
Able to tolerate oral intake
Mean days until clinical success achieved (range)
Recurrent obstruction
Recurrent obstruction at different site
Adverse events
Maldeployment
Destination limb not as expected
Bleeding
Perforation
Diarrhea
Postprocedural sepsis
Death during hospitalization
Procedural-related
Progressive cancer (comfort care or hospice)
Mean follow-up, days (range)
Values are n (%) unless otherwise defined.
can be found in the literature on the use of LAMSs for SBO
and colonic obstruction, a few studies have evaluated its
safety and efficacy.11,14-21 In this multicenter case series,
we present our experience with 26 consecutive patients un-
dergoing EUS-CE for SBO. We demonstrated that the pro-
cedure is technically feasible and has a positive impact on
patients’ clinical course with minimal adverse events when
performed by a skilled endoscopist.
Ensuring proper patient selection is crucial for the suc-
cess and safety of EUS-CE. In our cohort, most patients
with SBO requiring EUS-CE had advanced malignancy.
Therefore, multidisciplinary involvement of medical on-
cology, surgery, and, in some cases, interventional radiology
to consider and inform the patient of all treatment options is
essential, and EUS-CE should proceed only after multidisci-
plinary agreement. A thorough review of imaging, preferably
CT with intravenous or oral contrast, must be conducted to
determine the feasibility of the procedure.11 Many patients
with complex SBO will not have a viable window from the
colon to the small bowel, and this should be recognized
based on imaging. The presence of ascites should also be as-
sessed on CT, so it can be aspirated before the procedure if
appropriate. Although ascites is a relative contraindication to
LAMS placement, there are increasing reports of its use in
the presence of ascites with acceptable safety profiles
when certain protocols for paracentesis and diuretics are fol-
lowed.22 The likelihood of a stent leak is greatest during the
first week after LAMS placement, with this risk likely elimi-
nated at 2 to 4 weeks when tract maturation is theoretically
complete.6,11,22
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Colonic-enteric lumen-apposing metal stents
Values
26 (100)
24 (92.3)
24 (92.3)
22 (84.6)
6.0 (1-24)
4 (15.4)
4 (15.4)
4 (15.4)
0 (0)
0 (0)
1 (3.9)
0 (0)
2 (7.7)
1 (3.9)
2 (7.7)
0 (0)
2 (7.7)
54.8 (2-190)
After appropriate patient selection, our study demon-
strated a high rate of both technical and clinical success. Suc-
cessful LAMS placement was achieved in all patients in the
study. A recently published case series similarly reported
high rates of technical success with only 2 reported cases
in which the procedure was not performed because of an
inability to identify a suitable small-bowel target in 1 patient
and to traverse the sigmoid colon because of extrinsic tumor
burden in the other.11 Among patients with SBO in our
cohort, clinical success was achieved in 92.3% (24/26). Two
patients did not achieve clinical success, potentially because
of cancer progression. One patient’s symptoms did not
improve and continued to deteriorate even after the place-
ment of a LAMS. Consequently, the medical team decided
to transition the patient to hospice care at home. The other
patient experienced hemoptysis, possibly caused by lung
metastases. The family chose to withdraw from further med-
ical intervention, and the patient died the following day. In
addition to the 2 patients who did not achieve clinical suc-
cess, 2 other patients could not tolerate an oral diet (oral
diet tolerance in 84.6% [22/26]). These 2 patients were
chronically on parenteral nutrition before the procedure,
but their presenting symptoms (abdominal pain and disten-
sion) resolved after LAMS placement. Overall, the EUS-CE
procedure provided palliative care for obstruction and
improved end-of-life comfort for most patients (92.3%) in
our study.
The potential periprocedural adverse events of EUS-CE
must be considered along with its possible benefits. One
such adverse event is bleeding, which can occur because
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Colonic-enteric lumen-apposing metal stents
of various factors, including trauma to the blood vessels, GI
tract injury, or manipulation of surrounding tissues. Howev-
er, it is important to note that bleeding adverse events are
generally considered to be relatively rare during or after
EUS procedures. In our study, we did observe instances of
postprocedural bleeding in patients who underwent EUS-
CE, but it was effectively managed using conservative mea-
sures without the need for blood transfusion.
Another hypothetical concern associated with EUS-CE is
the potential for severe diarrhea, which can significantly
impact an individual’s quality of life. Before our study,
among the published case reports, only 1 patient was re-
ported as experiencing diarrhea 8 weeks after the proced-
ure.14 The LAMS location after EUS-CE in the small bowel
is difficult to control, but the location in the colon affords
some control. Whether the LAMS location after EUS-CE in
the colon impacts the severity of diarrhea is unclear. In our
study, 2 of 26 patients (7.7%) developed diarrhea after the
procedure. Symptomatic management was used for both pa-
tients. Although 1 patient exhibited a positive response to lo-
peramide, experiencing notable relief from symptoms, the
other patient’s condition persisted with frequent bowel
movements on a daily basis, despite attempts at various in-
terventions for alleviation. The LAMS locations in the colon
were descending and transverse colon in these 2 patients.
As for the small bowel, 1 LAMS was placed in the jejunum,
whereas the location of the other LAMS was not docu-
mented. Interestingly, 13 patients (50%) had LAMS place-
ment in the sigmoid region, but none of them experienced
postprocedural diarrhea. This may suggest predictive factors
for diarrhea (such as location of LAMSs in the small bowel or
motility/absorption related to underlying cancer) other than
the LAMS location in the colon.
Sepsis may occur after any transluminal procedure. In this
series, all patients were given periprocedural antibiotics.
Despite these measures, 1 patient developed shock likely
caused by sepsis with concern for procedure-related translo-
cation of enteric bacteria that required pressors and inten-
sive care unit admission. The patient responded well to
intravenous antibiotics and was safely downgraded to the
floor when hemodynamically stable and no longer requiring
pressors. The frequency of sepsis appears to be low overall
based on published case reports and case series and can
be reduced or prevented with timely administration of anti-
biotics.11,14-21
This study has several notable strengths, including a
multicenter patient population hospitalized for SBO and
the innovative use of the LAMS for this particular indica-
tion. To our knowledge, this represents the largest study
in the literature of patients who have undergone EUS-CE
with high rates of technical and clinical success. However,
several limitations of our study should also be noted. The
sample size was only 26 patients, likely because of the rar-
ity of the condition and novelty of this procedure. As a
result of the small sample size, subgroup analyses were
not possible. The duration of postprocedure follow-up
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Mitsuhashi et al
(mean, 60.8 days; range, 2-190) was also relatively short,
although this may be less clinically relevant given the
limited survival of this patient subset because of advanced
malignancy. Additionally, the retrospective design of this
study constitutes another acknowledged limitation. Finally,
it should be noted that the procedures were performed at
high-volume tertiary care centers with expert advanced en-
doscopists, and the generalization of these findings to
lower-volume centers may be limited.
As LAMS technology continues to evolve, its indications
are expected to expand, and further research will be
needed to mitigate adverse events. In this study, LAMSs
were used primarily as a compassionate salvage modality
in a patient population for which all other options had
been exhausted. There was no group for comparison be-
sides supportive and/or hospice care. Still patient selection
is crucial and should involve shared decision-making, a
thorough review of alternatives, and consideration of risks
and benefits. As EUS-CE becomes more established, the
technique will inevitably improve, potentially broadening
patient selection to those with longer life expectancies.
In conclusion, our study found that EUS-CE can be per-
formed with high rates of technical and clinical success.
However, the observed low rates of adverse events among
patients with SBO requires cautious interpretation because
of the study’s small sample size and the exclusive involve-
ment of experienced endoscopists. Given the novelty of
this procedure, discussions with patients should empha-
size the procedure goals and importance of skilled endo-
scopists experienced in LAMS placement within high-
volume tertiary care centers. With our findings and the cur-
rent expansion of LAMS applications, we expect more cen-
ters will adopt EUS-CE in the future. Further studies with
larger sample sizes, including prospective multicenter
studies, will help to confirm its efficacy and safety.
DISCLOSURE
The following authors disclosed financial relation-
ships: A. Chiang: Consultant for Medtronic. A. Kumar:
Consultant for Olympus. A. Schlachterman, T. Kowalski:
Consultant for Boston Scientific. D. Loren: Consultant
for Olympus, Boston Scientific, and Medtronic. M. Kaha-
leh: Consulant for and research grants from BSC, Med-
tronic, and Microtech; research grants from Pentax,
Olympus, and Fuji. All other authors disclosed no finan-
cial relationships.
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Abbreviations: EUS-CE, EUS-guided coloenterostomy; LAMS, lumen-
apposing metal stent; SBO, small-bowel obstruction.
Copyright ª 2024 by the American Society for Gastrointestinal Endoscopy
0016-5107/$36.00
https://doi.org/10.1016/j.gie.2023.11.003
Received August 8, 2023. Accepted November 6, 2023.
Current affiliations: Department of Medicine (1), Department of Medicine,
Division of Gastroenterology and Hepatology (2), Thomas Jefferson
University Hospital, Philadelphia, Pennsylvania, USA; Department of
Medicine, Division of Gastroenterology and Hepatology, Robert Wood
Johnson University Hospital, New Brunswick, New Jersey, USA (3).
Reprint requests: Shuji Mitsuhashi, MBBS, Department of Medicine, Thomas
Jefferson University Hospital, 833 Chestnut St, Ste 220, Philadelphia,
PA 19107.
Volume 99, No. 4 : 2024 GASTROINTESTINAL ENDOSCOPY 613