TECHNOLOGY STATUS EVALUATION REPORT

Endoscopic mucosal resection and endoscopic submucosal

dissection

The American Society for Gastrointestinal Endoscopy invasive, organ-sparing endoscopic removal of benign and
(ASGE) Technology Committee provides reviews of exist- early malignant lesions in the GI tract. For removal of larger
ing, new, or emerging endoscopic technologies that lesions, ESD is usually required. This report focuses on in-
have an impact on the practice of GI endoscopy. Evi- struments, injection solutions, and techniques currently
dence-based methods are used, with a MEDLINE litera- used during EMR and ESD.
ture search to identify pertinent clinical studies on the
topic and a MAUDE (Food and Drug Administration
TECHNOLOGY UNDER REVIEW
Center for Devices and Radiological Health) database
search to identify the reported complications of a given
EMR
technology. Both are supplemented by accessing the ‘‘re-
EMR is an endoscopic technique developed for removal
lated articles’’ feature of PubMed and by scrutinizing
of sessile or flat neoplasms confined to the superficial
pertinent references cited by the identified studies. Con-
layers (mucosa and submucosa) of the GI tract. EMR is
trolled clinical trials are emphasized, but in many cases
typically used for removal of lesions smaller than 2 cm
data from randomized controlled trials are lacking. In
or piecemeal removal of larger lesions. Most commonly
such cases, large case series, preliminary clinical studies,
used techniques can be subdivided as injection-, cap-,
and expert opinions are used. Technical data are gath-
and ligation-assisted EMR. Before the start of any EMR
ered from traditional and Web-based publications, pro-
technique, it may be helpful to mark the margins of a tar-
prietary publications, and informal communications
geted lesion with superficial cautery marks.
with pertinent vendors. For this review the MEDLINE da-
Injection-assisted EMR, also often called ‘‘saline-assis-
tabase was searched through September 2007 by using the
ted’’ polypectomy, is frequently used for large flat colon
key words ‘‘endoscopic lesion removal,’’ ‘‘endoscopic
polyps. This technique was introduced in 1955 for rigid sig-
mucosal resection,’’ ‘‘EMR,’’ ‘‘endoscopic submucosal
moidoscopy1 and then in 1973 for flexible colonoscopy.2
dissection,’’ and ‘‘ESD.’’
The procedure starts with injection of a solution into the
Technology Status Evaluation Reports are drafted by 1
submucosal space under the lesion, creating a ‘‘safety cush-
or 2 members of the ASGE Technology Committee,
ion.’’ The cushion lifts the lesion to facilitate its removal
reviewed and edited by the committee as a whole, and
and minimizes mechanical or electrocautery damage to
approved by the Governing Board of the ASGE. When
the deep layers of the GI tract wall. Injection-assisted
financial guidance is indicated, the most recent coding
EMR can be further subdivided into the ‘‘inject-and-cut’’
data and list prices at the time of publication are
technique (using an electrocautery snare through a sin-
provided. Technology Status Evaluation Reports are
gle-channel endoscope) or the ‘‘inject-lift-and-cut’’ tech-
scientific reviews provided solely for educational and
nique (using a grasping forceps to lift the lesion and an
informational purposes. Technology Status Evaluation
electrocautery snare through 2 separate channels of a dou-
Reports are not rules and should not be construed as
ble-channel endoscope).3 As a variation of the latter tech-
establishing a legal standard of care or as encouraging,
nique, EMR of large gastric lesions may be assisted by
advocating, requiring, or discouraging any particular
countertraction of the lesion with a grasping forceps placed
treatment or payment for such treatment.
through a percutaneous endoscopic gastrostomy tract.4 To
facilitate the basic processes of injection and snare excision
with 1 instrument, a device combining these 2 functions
BACKGROUND has recently been developed (Table 1).
Cap-assisted EMR also uses submucosal injection to lift
Endoscopic mucosal resection (EMR) and endoscopic the target lesion. Dedicated mucosectomy devices that
submucosal dissection (ESD) were developed for minimally use a cap affixed to the tip of the endoscope have been
developed (Table 1).5 These single-use devices come
Copyright ª 2008 by the American Society for Gastrointestinal Endoscopy equipped with a specially designed crescent-shaped elec-
0016-5107/$32.00 trocautery snare that must be opened and positioned on
doi:10.1016/j.gie.2008.01.037 the internal circumferential ridge at the tip of the cap.

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EMR and ESD

TABLE 1. Commercially available devices for EMR

Minimum working
channel required
Needle/snare device Gauge/snare size Manufacturer Cost ($US) (mm)

iSnare (combination injection 25-gauge needle US Endoscopy, Mentor, Ohio 125 3.2
needle and snare)
2.5  4 cm snare
Tissue collection devices Net size
Roth Net 3  6 cm US Endoscopy, Mentor, Ohio 75 2.8

Polyp-Pak, combination rotatable 3  6 cm US Endoscopy, Mentor, Ohio 85 2.8

snare and retrieval net
25 mm snare
Standard Nakao Spider-Net 3  6 cm ConMed Endoscopic 75 2.8
Technologies, Billerica, Mass
Mucosectomy devices Endoscope tip
diameter (mm)
EMR Kits (includes cap, needle, 9.3-10 Olympus America Inc, Center 191 2.0
and 25-mm crescent snare) Valley, Pa
Hard straight 13.9 mm cap 10-11
Hard straight 14.9 mm cap 9.3-10
Hard wide oblique 16.1 mm cap 10-11
Hard wide oblique 16.1 mm cap 8.6-9.2
Hard straight 12.9 mm cap 8.6-9.2

Hard wide oblique 16.1 mm cap 8.6-9

Soft oblique 18 mm cap 9.1-9.8 mm
Soft oblique 18 mm cap 9.8-10.4
Soft oblique 18 mm cap 10.3-11.3
Soft oblique 18 mm cap 11.2-11.8
Soft oblique 18 mm cap

Duette Multi-Band Mucosectomy Cook Medical Inc, 271

device Winston-Salem, NC
DT-6 9.5-13 3.7

DT-6-5F 9.5-13 2.8

DT-6-XL 11-14 3.7

The endoscope is then positioned immediately over the size of the lesion will determine the optimal size of the
target lesion, suction is used to retract the mucosa into cap. The largest caps (18 mm) are made from a soft mate-
the cap, and the snare is closed to capture the lesion. rial to allow passage through the narrow portions of the
The lesion is then resected with a standard snare excision GI tract (esophagus, pharyngoesophageal, and esophago-
technique. The available cap-assisted mucosectomy de- gastric junctions).
vices differ primarily in the characteristics of the cap. In ligation-assisted EMR, a standard variceal band ligation
Caps are composed of clear plastic that may be soft or device is positioned over the target lesion with or without
hard. The caps are cylindric and available with flat circular prior submucosal injection. Suction is applied to retract
(straight) or oblique-shaped tips both with outer diame- the lesion into the banding device, and a band is deployed
ters ranging from 12.9 to 18 mm. The oblique caps are to capture the lesion. The band has enough contractile
usually used for resection of esophageal lesions (to com- force to squeeze the mucosal and submucosal layers, but
pensate for the parallel position of the endoscope relative it is not strong enough to capture the muscularis propria
to the esophageal wall), whereas the straight caps are layer. The banding device is then removed and a standard
most commonly used in the stomach and colon. The electrocautery snare is used to resect the lesion above or

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 EMR and ESD

below the band.6,7 A recently introduced single-use banding encouraging results when autologous blood is used for sub-
device for mucosectomy (Table 1) uses a specially designed mucosal injection.13,22 The cushion created with autolo-
6-band ligator similar in design to variceal ligation devices. gous blood does not appear to interfere with visualization
This ligator’s handle has a larger diameter at the connection during EMR and lasts up to 7 times longer than a 0.9% saline
with the accessory channel of the endoscope permitting solution cushion.13
insertion of a snare device without removal of the banding
apparatus. It comes equipped with a 1.5 by 2.5 cm hexago- Retrieval of resected tissue
nal braided electrocautery snare available with a 5F or 7F Several options are available for collection of resected tis-
insertion sheath. Two sizes of ligating caps are available to sue. After the cap-assisted EMR, the resected pieces can be
fit endoscopes with outer diameters of 9.5 to 13 mm and collected into the cap and retrieved from the patient. The
11 to 14 mm. tissue resected during EMR or ESD can also be collected
by specially designed retrieval devices (Table 1): Roth Net
ESD (US Endoscopy, Mentor, Ohio), Spider-Net (ConMed Endo-
ESD has been developed for en bloc removal of large scopic Technologies, Billerica, Mass), and a combination
(usually more than 2 cm), flat GI tract lesions.8-11 The pro- of polypectomy snare and a retrieval net (Polyp-Pak, US
cedure is usually done in several steps. First, the margins of Endoscopy).
the lesion are marked by electrocautery, and submucosal
injection is used to lift the lesion. Then, a circumferential
CLINICAL APPLICATIONS
incision into the submucosa is performed around the lesion
with specialized endoscopic electrocautery knives (Table 2).
EMR and ESD may be used for definitive therapy of pre-
Finally, the lesion is dissected from underlying deep layers
malignant and early stage (T1mN0) malignant lesions of the
of GI tract wall with the electrocautery knife and removed.
digestive tract. EUS is often used for locoregional staging be-
After removal, the en bloc pathologic specimen should be
fore endoscopic resection to ensure that there is no tumor
mounted and oriented to facilitate histologic examination.
involvement of deeper wall layers or lymph nodes.23-26 EMR
Multiple cutting devices and accessories have been de-
and ESD also can be used to obtain larger histologic speci-
veloped specifically for ESD. These devices are not yet
mens (compared with standard endoscopic tissue sampling
commercially available in the United States.
techniques) and can provide an accurate histologic T stage
for these superficial malignancies.27 These techniques
Submucosal injection solutions
also can be used to sample or resect layers deep to the
For the submucosal injection used in all these tech-
mucosa and hence obtain a histologic diagnosis of subepi-
niques, the volume of injected fluid varies from 5 to 50 mL
thelial lesions in the GI tract located in the muscularis mu-
depending on the size of the lesion. Repeated injections
cosa or superficial submucosa.3,28,29 EMR and ESD should
can be required if the cushion dissipates before complete
not be attempted for lesions that do not ‘‘rise’’ during the
removal of the lesion. The addition of staining dye (ie,
submucosal injection because nonlifting of the tumor after
0.004% indigo carmine or methylene blue) to the injection
submucosal injection is a predictor of deep invasion and
solution is frequently used to assist in identifying the deep
that the lesion is not amenable to endoscopic removal.30-32
margin during the resection process.12
The role of ESD for colon lesions is less established. Mul-
Various solutions are currently used for submucosal in-
tiple factors make colon ESD more difficult compared with
jection (Table 3). The ideal agent should be inexpensive,
gastric ESD, including difficulties in maintaining the endo-
readily available, nontoxic, and easy to inject and provide
scope position, the thin colon wall with multiple folds,
a long-lasting submucosal cushion.13,14 Normal saline solu-
luminal angulations, and peristalsis.33 In addition, colon
tion is widely available and often used for injection-assisted
perforation with fecal spillage is generally more morbid
EMR. However, even with the addition of epinephrine,
than gastric perforation.33
a cushion made with normal saline solution often dissipates
within minutes. Multiple studies have demonstrated long-
lasting effects of cushions made with hyaluronic acid, EASE OF USE
hydroxypropyl methylcellulose (a semisynthetic viscous
ophthalmic solution used for artificial tears), glycerol, and EMR can be considered a variation of standard polypec-
a fibrinogen solution.15-19 Hyaluronic acid is expensive tomy with specialized devices, whereas ESD typically is
and not readily available in most endoscopy units.15,20,21 performed by endoscopists with experience in advanced
Hyaluronic acid and hydroxypropyl methylcellulose are procedures and familiarity with mucosal dissection tech-
very viscous and must be diluted to facilitate injection. In niques. Both EMR and ESD are technically difficult and
addition, tissue damage and local inflammatory reactions time-consuming procedures.34-36 For large gastric lesions,
have been reported at the injection sites of hydroxypropyl the reported time to complete EMR is 25.8  25.9 min-
methylcellulose, hypertonic sodium chloride (3.75%), and utes, whereas ESD lesion removal averages 84.0  54.6
hypertonic dextrose ( R 20%).20,22 Several studies report minutes.37 For colon lesions the average time required

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EMR and ESD

TABLE 2. Specialized endoscopic equipment used during ESD

Marketed in
Type Manufacturer Description Advantages Disadvantages United States

Needle-knives Olympus, Boston Fine tip with regulated Small contact area Perforation can be Yes
Scientific, Cook length with high cutting power easily caused by
Medical the needle knife’s tip
Insulated KD-610L, KD-611L, Ceramic ball on top Insulated tip prevents No
tip (IT) knife Olympus of needle knife perforation
Hook knife KD-620LR, Olympus Right angle bend of Rotatable tip can pull No
the tip of needle knife dissected tissue
Flex knife KD-630L, Olympus Soft cutting tip Flexible tip to prevent No
perforations

Triangle tip knife KD-640L, Olympus Triangle tip at the Can be used for No
distal end any step of procedure
Flush knife DK2618JN 10-30, Water jet from the tip Allows instant No
Fujinon of short needle-knife washout of blood
for clear view
Transparent hood DH-15CR, DH-16CR Attached to tip Improve visualization Need to front load No
Fujinon of endoscope by pushing tissues before procedure
away from endoscope

to complete ESD is reported as high as 70.5  45.9 min- with minor bleeding (hemoglobin decline !2 g/dL) as
utes, largely because of the difficulties mentioned above.33 the only complication.44
The positioning of the snare in the cap-assisted mucosec- Stomach. The largest experience in endoscopic treat-
tomy device before tissue capture may be challenging and ment of early gastric cancer is accumulated in Japan where
a relatively unfamiliar maneuver for endoscopists and as- approximately 50% of gastric cancers (10,000 cases yearly)
sistants. Ligation-assisted EMR does not require special are now discovered at an early stage.4,25,45-47 A summary of
prepositioning of the snare, and the concept of tissue endoscopic therapy outcomes for 1832 Japanese patients
capture is an extension of commonly used variceal band with early gastric cancer treated with EMR and ESD demon-
ligation. strated complete resection in 73.9% and a combined com-
plication rate of 1.9% (1.4% bleeding, 0.5% perforation).48
Duodenum. Benign periampullary lesions are usually
EFFICACY removed with a standard polypectomy snare without the
Esophagus. EMR and ESD are indicated for early submucosal injection techniques described for EMR.49 In
(T1mN0) moderately and well-differentiated squamous a review of 13 observational reports of papillectomy, some
cell esophageal cancer.38 Endoscopic therapy for superfi- using saline solution injection, the technical success rate
cial esophageal squamous neoplasms has a low complica- ranged from 50% to 100% with an adenoma recurrence
tion rate and a disease-specific 5-year survival rate of rate of 0% to 33%.50 There is 1 preliminary report of 3 pa-
95%.39-41 EMR and ESD are also gaining popularity for tients undergoing cap-assisted EMR as a follow-up therapy
high-grade dysplasia arising from Barrett’s esophagus and to successfully remove all residual adenoma tissue after
superficial esophageal adenocarcinoma.42 In observational standard snare ampullectomy.51 Endoscopic removal of ma-
studies Barrett’s epithelium is reported to be completely lignant ampullary tumors is usually inadequate, and these
replaced in 76.6% and resection for high-grade dysplasia patients should be referred for surgical resection.49,52,53
or early invasive cancer (T1N0) resulted in remission-free Duodenal adenomas located outside of the major duo-
survival with a median follow-up of 34.9 months. In these denal papilla are usually flat and can be removed with the
series, postprocedure complications occurred in 10.3% to simple inject-and-cut technique or with cap-assisted or
14.3% of patients.42,43 In a large prospective study of 100 ligation-assisted EMR. The majority of published reports
patients with low-risk lesions (less than 20 mm, limited on endoscopic removal of duodenal polyps are limited
to mucosa on the basis of EUS, well or moderately differen- by the small number of patients and their retrospective
tiated, and no lymph or venous invasion), treated with design.49,50 Reported success rates vary from 74% to 93%
either cap-assisted or ligation-assisted EMR, there was an for ampullary and 62% for nonampullary duodenal
11% recurrence rate at a mean follow-up of 36 months lesions.49,50,54,55

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 EMR and ESD

TABLE 3. Solutions for submucosal injection during EMR and ESD

Cushion duration Advantages Disadvantages

Normal saline solution (0.9%) þ Easy to inject, cheap, readily Quickly dissipates (short duration
available of cushion)
Hypertonic solution of sodium þþ Easy to inject, cheap , cheap, Tissue damage, local inflammation
chloride (3.0%) readily available at sites of injection
Hyaluronic acid þþþ Longest lasting cushion Expensive, not available in most
endoscopy units, special
requirements for storage, might
stimulate growth of residual
tumor cells
Hydroxypropyl methylcellulose þþþ Long-lasting cushion, relatively Tissue damage, local inflammation
inexpensive at sites of injection
Glycerol þþ
Dextrose (20%, 30%, 50%) þþ Cheap, readily available Tissue damage, local inflammation
at sites of injection
Albumin þþ Easy to inject, available in most Expensive
endoscopy units
Fibrinogen þþþ Easy to inject, long-lasting cushion Expensive, not readily available
Autologous blood þþþ Clotting in syringe if injection Religious beliefs may preclude;
delayed limited human data

Colon. EMR is widely used for resection of flat benign removal of gastric (prepyloric) lesions.27,72,80-82 These stric-
colon lesions, although this is typically done with a simple tures are more common after removal of large lesions occu-
inject-and-cut technique as opposed to the ligation or cap- pying more than 75% of the esophageal circumference and
assisted techniques. Although even large benign colon usually can be successfully treated by endoscopic dilation.83
polyps can be removed endoscopically, the reported Endoscopic removal of lesions affecting the major duo-
recurrence rates range as high as 21.4% to 46%, which jus- denal papilla is associated with an increased risk of postpro-
tifies aggressive surveillance for detection and removal of cedure pancreatitis, which may be reduced by prophylactic
recurrent or residual lesions.34,56-59 Although several stud- stenting of the pancreatic duct.84,85 Postpapillectomy bleed-
ies have reported no recurrence after endoscopic removal ing is another frequent complication and argon plasma
of malignant colon polyps, the effectiveness of EMR for coagulation can be used to control bleeding and may be
treatment of these lesions has been questioned and helpful as an adjunctive therapy to destroy residual adeno-
EMR should not be attempted for indurated, ulcerated, matous tissue.49,86
or ‘‘nonlifting’’ colon lesions.34,60-62

SAFETY FINANCIAL CONSIDERATIONS

Although EMR and ESD have obvious benefits for pa-

Bleeding is the most common complication of EMR and
tients with benign and early malignant lesions of the GI
ESD, with rates reported ranging from 1% to 45% with
tract, these endoscopic techniques are both technically de-
average rates of 10% in larger series.60,63-68 Most bleeding
manding, time consuming, and are not adequately reim-
is observed during the procedure or within the first 24
bursed at the present time.34,35,87 There are no unique
hours.12 Delayed bleeding has been reported in up to
Current Procedural Terminology (CPT)* codes for EMR
13.9% of patients.69,70
Reported perforation rates during ESD (4%-10%) are
much higher compared with EMR (0.3%-0.5%).33,35,71-77 * Current Procedural Terminology (CPT) is copyright 2008 American
Small perforations recognized during the procedure can Medical Association. All Rights Reserved. No fee schedules, basic units,
be successfully sealed with endoscopic clips.18,78,79 Large relative values, or related listings are included in CPT. The AMA assumes
perforations require urgent salvage surgery to prevent no liability for the data contained herein. Applicable FARS/DFARS
restrictions apply to government use.
peritonitis.12 CPT is a trademark of the American Medical Association.
Stenosis has been reported in 6% to 26% of patients after Current Procedural Terminologyª 2008 American Medical Association. All
endoscopic removal of esophageal lesions and in 3.3% after Rights Reserved.

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EMR and ESD

or ESD.87 The most applicable identifiers are 43236 (sub- comes and development of devices to enhance safety
mucosal injection during EGD), 45381 (submucosal injec- are needed.
tion during colonoscopy), 43251 (snare polypectomy
during EGD), and 45385 (snare polypectomy during colo- Abbreviations: ASGE, American Society for Gastrointestinal Endoscopy;
noscopy). If adjunctive mucosal ablation of lesion margins CPT, Current Procedural Terminology; ESD, endoscopic submucosal
dissection; MAUDE, Food and Drug Administration Center for Devices
is used, an additional code 43258 (ablation during EGD) and Radiological Health.
and 45383 (ablation during colonoscopy) can be attached
to the primary procedure code. Ordinarily the polypec-
tomy (highest reimbursed of existing CPT codes) would REFERENCES
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resection is effective for complete removal of Barrett’s esophagus with

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