Surg Endosc
DOI 10.1007/s00464-014-3948-1
DYNAMIC MANUSCRIPT
Assessment of the length of myotomy in peroral endoscopic
pyloromyotomy (G-POEM) using a submucosal tunnel technique
(video)
Yunho Jung Jongchan Lee Mark A. Gromski
Masayuki Kato Sam Rodriguez Ram Chuttani
Kai Matthes
Received: 13 March 2014 / Accepted: 7 October 2014
Springer Science+Business Media New York 2014
Abstract
Background Peroral endoscopic pyloromyotomy is a
novel technique that has recently been described in the
literature. There is little data to guide the length of myot-
omy created. The aim of study was to evaluate the proper
incision length of the muscular layer during peroral endo-
scopic pyloromyotomy using a submucosal tunnel
technique.
IRB/IACUC The study required no IRB or IACUC review since no
human subjects or live animals were used in the study. Ex vivo
porcine specimens were utilized from a commercial distributor.
Electronic supplementary material The online version of this
article (doi:10.1007/s00464-014-3948-1) contains supplementary
material, which is available to authorized users.
Y. Jung (&)
J. Lee
M. A. Gromski
M. Kato

R. Chuttani
K. Matthes
Division of Gastroenterology, Department of Medicine, Beth
Israel Deaconess Medical Center, Harvard Medical School,
Boston, MA, USA
e-mail: yoonho7575@naver.com
K. Matthes
e-mail: kmatthes@bidmc.harvard.edu
Y. Jung
Division of Gastroenterology, Department of Medicine,
Soonchunhyang University College of Medicine, Cheonan,
Korea
M. Kato
Department of Endoscopy, The Jikei University School
of Medicine, Tokyo, Japan
S. Rodriguez
K. Matthes
Department of Anesthesiology, Perioperative and Pain Medicine,
Childrens Hospital Boston, Harvard Medical School,
300 Longwood Avenue, Boston, MA 02115, USA
and Other Interventional Techniques
Methods The study was designed as a prospective ex vivo
study. Fresh ex vivo porcine stomachs from animals
weighing 80100 kg and porcine stomachs from animals
weighing 1525 kg were used for pyloromyotomy. Four
different myotomy lengths (1, 2, 3, and 4) were compared
in the large animal series and three different myotomy
lengths (1, 2, and 3) were compared in the small series. A
total of 23 cases of the submucosal tunnel technique were
performed by two endoscopists using 12 large stomachs
and 11 small stomachs.
Results The mean overall procedure time (SD) of pylo-
romyotomy was 65.7 (14.3) min. In the large stomach series,
the mean pyloric diameter (SD) and change from baseline
(as percentage) following a 1, 2, 3, and 4 pyloromyotomy were
13.3 9.5 mm (7.1 %), 20.7 11.7 mm (10.6 %),
31.1 15.0 mm (15.2 %), and 33.0 15.0 mm (16.0 %),
respectively. In the small stomach series, the changes of mean
pyloric diameter following a 1, 2, and 3 cm pyloromyotomy
were 12.2 5.6 mm (7.5 %), 23.1 7.6 mm (13.1 %), and
28.0 10.4 mm (15.5 %), respectively.
Conclusions A 3 cm pyloromyotomy for a large animal
series and 2 cm for the small animal series appeared to be
most appropriate for enlargement of the pylorus.
Keywords Stomach
Pylorus
Myotomy
Hypertrophic pyloric stenosis is a relatively common con-
dition in 26-week-old infants, which presents with pro-
gressive projectile, non-bilious vomiting. The incidence is
approximately 24 per 1,000 live births in Western popula-
tions [1]. Indeed, it is the most common surgical condition
producing emesis in infancy [2, 3]. The pyloric portion of the
stomach becomes abnormally thickened and manifests as
gastric outlet obstruction. Most surgical interventions for
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pyloric stenosis currently utilize a laparoscopic technique.
Confirming the perceived benefit of minimally invasive
surgical techniques, a recently published survey demon-
strated that 85 % of parents of an infant with hypertrophic
pyloric stenosis would be willing to pay additional out-of-
pocket expenses for smaller, less visible scars [4].
Gastroparesis is characterized by delayed gastric emp-
tying in the absence of anatomical obstruction. It is a
chronic digestive disorder, seen most frequently in patients
with diabetes mellitus, with symptoms of nausea, vomiting,
bloating, and abdominal pain. Symptoms attributable to
gastroparesis are reported in up to 12 % of patients with
diabetes [5, 6]. Patients with gastroparesis often suffer from
a comparatively poor quality of life and severe gastropa-
resis may result in recurrent hospitalizations, malnutrition,
and increased mortality [7, 8].
Antral and pyloric dysfunctions have been demonstrated
in the pathogenesis of gastroparesis [9, 10]. Manometric
studies of patients with diabetic gastroparesis have shown
prolonged periods of increased pyloric tone and phasic
contractions, a phenomenon termed pylorospasm [10].
Endoscopic therapies directed at the pylorus such as dila-
tion and intra-pyloric botulinum toxin injection have been
shown to temporarily improve gastric emptying [1113].
The reported duration of benefit from pyloric botulinum
toxin injection is from 1 to 5 months, often necessitating
repeat injections [14]. Prokinetics, such as domperidone,
metocropramide, and erythromycin, are used routinely for
symptomatic treatment. Symptom resolution with medical
treatment, however, is not assured, and side effects include
fatigue, abdominal cramping, drowsiness, tachyphylaxis,
and tardive dyskinesia [15]. For the relatively rare case of
severe, refractory gastroparesis, surgical interventions are
considered, including pyloroplasty, complete or partial
gastrectomy, and feeding jejunostomy. Michael et al. [8]
demonstrated that minimally invasive pyloroplasty pro-
vided positive outcomes for patients with gastroparesis.
An endoscopic peroral pyloromyotomy was first
described in infants with pyloric stenosis in 2005 [3]. The
authors postulated advantages of the peroral endoscopic
approach to be potential overall cost reduction, reduced
length of hospitalization, earlier feeding, and the elimina-
tion of visible surgical scars. It is, however, difficult to
precisely cut the muscle layer using a direct endoscopic
technique, which has resulted in a potential risk of bleeding
and perforation. An adequate and safe technique of endo-
scopic pyloromyotomy is still to be determined. The first
endoscopic peroral pyloromyotomy was recently described
in the literature this year [16]. Regarding nomenclature, the
endoscopic pyloromyotomy is technically a version of
peroral endoscopy myotomy. In distinction from a myot-
omy in the esophagus in the more conventional E-POEM
for achalasia, this initiates as a gastric incision, thus we
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Surg Endosc
Fig. 1 Large and small porcine ex vivo stomach
term our peroral endoscopic pyloromyotomy in this paper
as G-POEM or gastric peroral endoscopic myotomy.
The aim of this study is to compare the degree of dila-
tion of the pyloric opening of varying incision lengths of
the pyloric muscle, to help determine which incision length
is most appropriate for G-POEM, using a submucosal
tunnel technique.
Materials and methods
This study is a prospective ex vivo animal study. Fresh
ex vivo esophagus-stomach-duodenum packages were
harvested from two groups of white Yorkshire pigs
weighing either 80100 kg (age 618 months) or 1525 kg
(age \ 1 month). We created this study utilizing two dis-
tinct groups of stomach sizes (large and small animal ser-
ies) to represent the indication of pyloromytomy in adults
with delayed gastric emptying versus in infants with
hypertrophic pyloric stenosis. The sizes of the stomachs
corresponded to the size of the stomach of human patients
in the corresponding age groups (Fig. 1). Two advanced
endoscopists experienced in submucosal endoscopy per-
formed the procedures, and the large and small stomachs
were distributed equally and randomly between the two.
The specimens were used with the EASIE-R simulator
platform (Endosim, LLC, Hudson, MA). The study
required no internal review board approval as there were no
human research subjects involved and no live animals
involved.
In each ex vivo stomach, the baseline pyloric diameter
and muscle tone were measured and recorded by the En-
doFLIP Imaging System (Cronspon, Galway, NH). Fol-
lowing baseline measurements, a 1 cm pyloromyotomy
was performed and then the pyloric opening diameter and
muscle tone were recorded again. Then, the length of the
Surg Endosc

Fig. 2 Endoscopic view of the

pyloromytomy. A The opening
site of the submucosal tunnel,
determined by a ruler at a
distance 5 cm from the pylorus,
with proximity to the greater
curvature. B Saline/methylene
blue mixture injected into the
submucosal layer from the
opening site to the pylorus,
along the expected submucosal
tunnel tract. C The submucosal
dissection using the IT knife.
D The pyloromyotomy using a
triangle tip knife

myotomy was extended to 2 cm and then the pyloric

opening diameter and pyloric muscle tone was measured
again. This was repeated to a 3 cm length of myotomy in
the small animal series and additionally to a 4 cm length of
myotomy in the large animal series.

Determination of the location of the submucosal tunnel

The submucosal tunnel was created by choosing an entry

point in the antrum at the greater curvature 5 cm proximal
to the pyloric opening, as measured by a ruler (Fig. 2A).
Normal saline admixed with methylene blue was injected
into the submucosal layer at the location that was selected
for the submucosal tunnel and along the expected submu-
cosal tunnel line (Fig. 2B).

Creation of the submucosal tunnel and pyloromyotomy

The submucosal tunnel was created using a single-channel

gastroscope (GIF-Q180, Olympus America Inc, Center
Valley, PA, USA) and the submucosal dissection was
performed using a combination of three needle knives: the
hook knife, dual knife, and IT knife (Olympus America
Inc.) (Fig. 2C). A transparent cap (D-201-1704, Olympus,
Tokyo, Japan) was affixed to the distal end of the endo-
scope for the procedures. The pyloric junction was recog-
nized by visualization of the previously injected color dye
material and by identifying landmarks of an abruptly
Fig. 3 Illustration of gastric endoscopic peroral myotomy (G-
POEM). A Determination of the entrance of the submucosal tunnel
and initial submucosal injection, B creating the opening of the
submucosal tunnel via a mucosal cut, C dissection creating the
submucosal tunnel and pyloromyotomy, D closure with a mucosal
clip

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Fig. 4 The measurement of pyloric distension using the EndoFLIP
Imaging System. A The balloon tip of the EndoFLIP catheter was
inflated traversing the pylorus. B Distended pyloric diameter after a
narrowed space. After verifying the incision length with an
endoscopic ruler, a triangle tip knife was used to catch
circular muscle and lift it toward the tunnel lumen, after
which we then carried out the myotomy (Fig. 2D). The
summarized endoscopic technique of G-POEM is similar in
many respects to E-POEM. The procedure of G-POEM
consists of the following primary steps: (a) Determination
for the opening of the submucosal tunnel, (b) Injection,
(c) Creation of submucosal tunnel and pyloromyotomy,
and (d) Closure (Fig. 3).
Assessment of pyloric distensibility and complications
The EndoFLIP Imaging System was used for assessment of
the pyloric compliance before and after the initial pyloro-
myotomy, and after every incremental extension of the
myotomy (Fig. 4A). The EndoFLIP system is comprised of
a measurement display unit and a sensing 25-mm balloon
probe housing an array of 16 pairs of electrodes spaced
5 mm apart, to measure multiple diameters and cross-sec-
tional areas at fixed intervals along the catheter. For the
distension protocol, the balloon was inflated to 40 mL at a
rate of 40 mL per min. This system provides a dynamic
representation of the luminal geometric changes based on
impedance planimetry, which assesses how easily a high-
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Surg Endosc
1 cm myotomy in the large stomach. C Distended pyloric diameter
between 2 and 3 cm myotomy in the large stomach
pressure zone will stretch further for a given distending
pressure. After endoscopic pyloromyotomy, we tested the
compliance, or distensability, at the pyloric junction, as it
may aid in determining pyloric dynamics (Fig. 4B, C).
The following outcomes of each procedure were recor-
ded by an independent observer: total procedure time (not
including endoflip measurements), opening size, the length
of pyloric tunnel, the distending diameter of pylorus, and
perforation of mucosal and serosal area.
Statistical analysis
The sample size was calculated using preliminary data
obtained from seven samples in each group of incision
length from each size group (large vs. small stomachs) and
a one-way ANOVA method was used to estimate sample
size. In the large stomach group, an estimated sample size
of 44 measurements was determined, with an alpha of 0.05
and a power of 80 %. In the small stomach group, an
estimated sample size of 33 measurements was determined,
with an alpha of 0.05 and a power of 80 %. Data were
analyzed using SPSS software, version 18.0 (SPSS Inc,
Chicago, Ill). Statistical comparisons were made between
groups using the one-way ANOVA test and statistical
significance was defined as P \ 0.05.
Surg Endosc

Table 1 The results of pyloromyotomy in large and small stomachs

Type of Parameters (mean) The length of myotomy (cm)
stomach
Baseline 1 2 3 4

Large Distending diameter 17.9 1.4 19.2 1.8 20.0 2.0 21.0 2.1 21.2 2.2
stomach (cm)
D Distending diameter 13.3 9.5 mm 20.7 11.7 mm 31.1 15.0 mm 33.0 15.0 mm
(%) (7.1 %) (10.6 %) (15.2 %) (16.0 %)
D Distending area 13.4 8.2 19.9 8.8 27.8 9.9 29.1 10.3
(mm2) (%)
Small Distending diameter 13.8 1.1 15 0.9 16.1 1.2 16.6 1.3
stomach (cm)
D Distending diameter 12.2 5.6 mm 23.1 7.6 mm 28.0 10.4 mm
(%) (7.5 %) (13.1 %) (15.5 %)
D Distending area 14.3 6.4 24.4 6.7 28.4 8.8
(mm2) (%)

13.3 9.5 mm (7.1 %) after a 1 cm myotomy, 20.7

11.7 mm (10.6 %) after a 2 cm myotomy, 31.1 15.0 mm
(15.2 %) after a 3 cm myotomy, and 33.0 15.0 mm
(16.0 %) after a 4 cm myotomy. The changes of the mean
distending pyloric area (mm2) were: 13.4 % (8.2) after a
1 cm myotomy, 19.9 % (8.8) after a 2 cm myotomy,
27.8 % (9.9) after a 3 cm myotomy, and 29.1 % (10.3)
after a 4 cm myotomy.
The change of mean distending pyloric diameter was
significantly larger after the 3- and 4-cm incision, when
compared to the 1-cm incision (P = 0.011 and P = 0.004,
respectively), but there was no statistically significant dif-
ference between the 3 and 4 cm myotomy (P = 1.00)
(Fig. 5).

Fig. 5 The mean changes of the distending pyloric diameter

comparing different lengths of myotomy in the large stomach group Results of the small stomach group

Eleven cases of endoscopic pyloromyotomy using the

Results
A total of 23 cases of the submucosal tunnel technique
were performed by two endoscopists, in 12 large stomachs
and 11 small stomachs (video 1). A total 81 pyloric muscle
tone measurements after myotomy were recorded, repre-
senting incremental increase of each pyloromyotomy size.
Results of the large stomach group
A total of 12 cases of endoscopic pyloromyotomy using the
submucosal tunnel technique were performed, carried out
with a four-step, graded incision of the pyloric muscle, and
the distending diameter of pylorus was measured by the
EndoFLIP Image System after each interval. A total of 48
measurements were performed. The changes (expansion)
of the mean distending pyloric diameter (SD) were:
submucosal tunnel technique were performed in the small
stomach group using a three-step graded pyloromyotomy
incision, and the distending diameter of the pylorus was
measured after each gradation. A total of 33 measurements
were recorded. The changes of the mean distending pyloric
diameter were: 12.2 5.6 mm (7.5 %) after a 1 cm
myotomy, 23.1 7.6 mm (13.1 %) after a 2 cm myotomy,
and 28.0 10.4 mm (15.5 %) after a 3 cm myotomy. The
changes of the mean distending pyloric area (mm2) were:
14.3 % (6.4) after a 1 cm myotomy, 24.4 % (6.7) after
a 2 cm myotomy, and 28.4 % (8.8) after a 3 cm myot-
omy The mean change of the distending pyloric diameter
was significantly larger after the 2- and 3-cm incisions
when compared to the 1-cm incision (P = 0.012 and
P \ 0.001, respectively). There was no statistically sig-
nificant difference between the 2 and 3 cm myotomy
(P = 0.504) (Fig. 6) (Table 1).

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Fig. 6 The mean changes of the distending pyloric diameter
comparing different lengths of myotomy in the small stomach group
Overall results of pyloromyotomy
The mean overall procedure time (SD) of the pyloro-
myotomy procedures was 65.7 (14.3) min. The mean
mucosal tunnel opening size and length of submucosal
tunnel were 1.91 (0.44) cm and 5.89 (0.99) cm,
respectively. The overall serosal perforation rate was
26.1 % (6/23) and mucosal perforation rate was 8.7 % (2/
23).
Discussion
Kawai et al. [17] demonstrated the feasibility of G-POEM
using a live pig model. The authors showed that the median
pyloric resting pressure was reduced from 16.5 to
6.1 mmHg immediately after myotomy and 8.4 mmHg at
14 days following myotomy [17]. However, this study
involved a small sample size and the ideal incision length
to achieve maximal opening of the pyloric sphincter has yet
to be determined. An approximate incision length of 2 cm
for laparoscopic pyloromyotomy was described as an
effective incision length in infant pyloric hypertrophic
stenosis [18] but it is unknown whether this incision length
is most appropriate for the endoscopic technique, as the
approach is from the mucosal side instead of serosal side.
Our team attempted a G-POEM technique by directly
approaching the muscular layer under the direct visuali-
zation via a submucosal tunnel created by endoscopic
knives. We performed a stepwise myotomy approach to
determine the most efficacious myotomy size by extending
the incision of the pyloric muscle from 1 to 4 cm in large
stomachs and 13 cm in small stomachs. Of note, each
G-POEM technique did not result in entire transection of
the pyloric muscle from antrum to duodenum. Most of the
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final group incisions (3 cm in small group and 4 cm in
larger group) resulted in extension of the myotomy into a
small part of the duodenum.
The mean diameter of pyloric distension was signifi-
cantly larger after a 3 or 4 cm myotomy in the large
stomach group and 2 or 3 cm in the small stomach group
compared to a 1-cm incision. This may indicate that the
most appropriate incision length should be at least 3 cm in
large (i.e., adult) stomachs and 2 cm in small (i.e., pedi-
atric) stomachs. In some cases of gastric outlet syndrome,
where the main issue may be resolved with some increased
pyloric distension, a complete myotomy of the pyloric
muscle may not be required. Given the significant risks of
G-POEM extending completely into the duodenal muscle,
the risks of a complete myotomy may be greater than the
potential benefits. The duodenal segment contains larger
blood vessels generally and the duodenal wall is signifi-
cantly thinner, making submucosal dissection and myot-
omy quite difficult, increasing risk for duodenal
perforation.
Our overall serosal perforation rate was 26.1 % (6/23)
and mucosal perforation rate was 8.7 % (2/23). One reason
for the relatively high serosal perforation rate is likely the
use of ex vivo specimens, in which it can be difficult to
distinguish between the circular and oblique muscle layers
during the ESD tunnel technique, which may result in
inadvertent incision of deeper muscular layers that could
potentially be prevented in human patients. Recent studies,
however, regarding esophageal peroral endoscopic myot-
omy (E-POEM), showed a mucosal or serosal perforation
rate of 6.2520 % [19, 20]. Although full-thickness per-
forations can lead to pneumoperitoneum or pneumomedi-
astinum, they showed little clinical significance when the
mucosal surface remains intact [21]. Therefore, a small
perforation during G-POEM may not necessarily result in
peritonitis, given the protective utilization of the submu-
cosal tunneling technique. The submucosal tunnel tech-
nique, as demonstrated in NOTES procedures reported in
the literature, has shown to be a safe peritoneal access
technique and allow for secure gastric closure. The tunnel
promotes a protective barrier without direct communi-
cation between the lumen of the organ and the peritoneum
[22]. The retained mucosal flap of the submucosal tunnel
should be securely closed with endoscopic clips, thereby
preserving the integrity of the mucosal lining and reducing
the risk of peritoneal leakage. In our study, it is also pos-
sible that the repeated distension measurements could have
led to an increased rate of perforation. Additionally, each
procedure in each specimen had a graded enlargement of
the myotomy incision, likely beyond the length that would
be clinically necessary, which may also have contributed to
a higher rate of perforation. It was our experience that the
smaller porcine stomachs were slightly technically more
Surg Endosc
difficult to perform the procedure safely compared to the
larger stomachs. There were four serosal perforations in
the smaller stomachs and two serosal perforations in the
larger stomachs. We believe this is secondary to the
smaller lumen of the smaller stomachs. This created a
tighter fit and marginally more difficult maneuverability
of the endoscope within the submucosal space. There was
a trend toward more perforations earlier in the study
compared to later in the study, which may have been
related to the endoscopists gaining more experience with
G-POEM. As with any advanced new technique, even
expert endoscopists generally improve with the technique
of a procedure as they perform more. This study was not
designed to evaluate whether a learning curve of the
procedure was present. There were no significant differ-
ences in number of perforations between the two
endoscopists.
The mean overall procedure time (SD) of pyloro-
myotomy was 65.7 (14.3) min. To perform the pro-
cedure most efficiently, we injected the normal saline
with methylene blue from the opening site to the pylorus
along the expected submucosal tunnel line. A dyed
solution was injected in the pylorus from the mucosal
side. This provided some orientation and direction both
while creating the submucosal tunnel and also while
making the myotomy incision. Of note, this procedure
time did include the graded myotomy incisions. A sin-
gular incision, as may be performed in clinical practice,
would likely take less time.
There are some limitations to this study. This was a
small, ex vivo study that specifically was designed to
characterize the optimal size of pyloromyotomy incision.
Since it was an ex vivo study, we could not assess any
clinical symptoms or symptom resolution post-procedur-
ally. Being an ex vivo study, it is possible that there are
some small difference of pyloric character between live
and harvested organs. Also, we encountered no bleeding-
related complications and no stomach movement as may be
seen in live animals or in human subjects.
Our study confirmed that a peroral endoscopic pylo-
romyotomy (G-POEM) using a submucosal tunnel tech-
nique results in an effective increase in pyloric opening
area and diameter. We were able to quantify the extent of
dilation in comparison to the pyloric muscle incision
length. We found a significant increase in pyloric opening
at a 3 cm pyloromyotomy for large stomachs and 2 cm
for small stomachs, corresponding with adult or infant
patients. Next a large-animal survival trial (and subse-
quently human trials) will be needed to confirm our
results and to investigate the relevance of alkaline reflux
and clinical symptom resolution, in addition to further
characterizing the safety and long-term efficacy of this
procedure.
Disclosures Kai Matthes: Olympus America Inc. (consultation and
material support), Ovesco Endoscopy USA Inc. (consultation and
material support), Endosim LLC (ownership). Mark Gromski: En-
dosim LLC (consultant). Ram Chuttani: ConsultantOlympus
America. Yunho Jung, Jongchan Lee, Masayuki Kato, Sam Rodriguez
have identified a conflict of interest.
Funding Olympus America Inc. (Center Valley, PA), Endosim,
LLC (Berlin, MA), Medical Measurement Systems (Cronspon, Gal-
way, NH) provided material support.
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