Digestive Endoscopy 2018; 30 (Suppl. 1): 25–31
13042
Review
Current status and feasibility of endoscopy full-thickness resection
Current status and future perspectives of endoscopic full-
thickness resection
Hirohito Mori, Hideki Kobara, Noriko Nishiyama and Tsutomu Masaki
Department of Gastroenterology and Neurology, Faculty of Medicine, Kagawa University, Kagawa, Japan
Flexible endoscopy has developed from a diagnostic tool for
tissue biopsy sampling to a treatment tool for endoscopic
resection of neoplasms in the digestive tract. In the near future,
one of the advanced endoscopic techniques, endoscopic full-
thickness resection (EFTR), is expected to be a feasible
endoscopic procedure. In the present review, systematic review
of conventional exposed EFTR was carried out. Search queries
were (endoscopic full-thickness resection or EFTR) (over-the-
scope clip or OTSC) (Overstitch System) from 2015 to 2017. Four
retrospective, single-center studies with regard to conventional
EFTR were identified. With regard to indication for conventional
exposed EFTR, gastrointestinal stromal tumor was a good
INTRODUCTION
O RIGINALLY, A FLEXIBLE endoscope was devel-
oped as a diagnostic tool to observe inside the digestive
tract lumen. After development of a working channel, it has
been used as a tool for therapeutic procedures such as
polypectomy or endoscopic mucosal resection (EMR) to
remove mucosal lesions. Later, endoscopic submucosal
dissection (ESD) was developed and it has been established
as a minimally invasive treatment for neoplastic lesions in the
digestive tract.1–4 Currently, esophageal, gastric and colorec-
tal ESD are covered by health insurance in Japan as standard
treatment. Furthermore, nowadays, development of both
ESD techniques and its devices, such as electronic knives and
hemostatic forceps, and advanced endoscopic procedures etc.
is occurring. One of these advanced procedures, endoscopic
full-thickness resection (EFTR) is expected to be a feasible
endoscopic procedure. To carry out EFTR safely, reliable
endoscopic suturing devices are necessary to close resected
openings. One of the currently available commercialized
devices for flexible endoscopy is the Overstitch System
(Apollo Endosurgery, Austin, TX, USA), which is a full-
Corresponding: Hirohito Mori, Department of Gastroenterology
and Neurology, Kagawa University, 1750-1 Ikenobe, Miki, Kita,
Kagawa 761-0793, Japan. Email: hiro4884@med.kagawa-u.ac.jp
Received 21 November 2017; accepted 12 February 2018.
© 2018 Japan Gastroenterological Endoscopy Society
doi: 10.1111/den.
indication for EFTR. Mean tumor size of all four studies was
20.71 mm. In two studies, endoclips were used to close the
resected opening without any complications, but the other two
studies reported complications such as delayed perforation even
using OTSC. Procedure times were reported from a minimum of
40 min to a maximum of 105 min. We also refer to introduction
of a newly developed procedure of EFTR (non-exposed EFTR),
and development of a new suturing device in Japan.
Key words: endoscopic full-thickness resection, endoscopic
submucosal dissection, full-thickness suturing device, newly
developed procedure, over-the-scope clip
thickness suturing device using surgical threads.5 Another
clip-based full-thickness suturing device is the over-the-
scope clip (OTSC) (Ovesco Endoscopy GmbH, T€ ubingen,
Germany), and usefulness of the device for closure of fistulas,
iatrogenic perforations and anastomotic leakage after surgery
is reported in a number of articles.6,7 As a more advanced
device, full-thickness resection device (FTRD) was recently
released to enable non-exposed EFTR using the OTSC
system.8–10 If problems of infection and intraperitoneal
dissemination of tumor cells are solved, gastric gastrointesti-
nal stromal tumor (GIST) would be a good candidate for
EFTR.11–13
METHODS
Article review of conventional exposed EFTR
S YSTEMATIC REVIEW FOR conventional EFTR was
carried out with regard to indications, lesion size,
procedure time and complications. Relevant studies were
identified by searching PubMed/MEDLINE with key words
of (endoscopic full-thickness resection or EFTR) AND
(over-the-scope clip or OTSC) AND (Overstitch System)
from 2015 to 2017. All identified references were carefully
inspected, and studies were selected if outcomes were
appropriately mentioned. Case reports/series and animal
studies were excluded.
25
26 H. Mori et al. Digestive Endoscopy 2018; 30 (Suppl. 1): 25–31

Four retrospective, single-center studies with regard to

Success rate (%)

conventional EFTR were identified by the above-mentioned

98
100

100

97/100/100
searching strategy.

Introduction of newly developed EFTR

procedure (non-exposed EFTR)

postoperation fever
peritonitis, four
After discussing the results of the systematic review of the

Complications

Two localized
studies and indications for conventional exposed EFTR

None

None

None
procedures, non-exposed EFTR by FTRD, EFTR-related

EFTR, endoscopic full-thickness resection; MP, muscularis propria; SET, subepithelial tumor; SMT, submucosal tumor; OTSC, over-the-scope clip.
submucosal tunneling enucleation procedures (submucosal
tunnel endoscopic resection [STER] and endoscopic sub-
mucosal tunnel dissection [ESTD]) were introduced.

Clip-with-thread
Closure device

method/loop-
Endoclip and
Presentation and development of a new

endoloop
Endoclips

assisted
suturing device in Japan

method
OTSC
RESULTS

Procedure time (min),

Article review of conventional exposed EFTR

median (range)

40.5 (16–104)
105 (60–145)

52 (30–125)

85 (40–180)
45 (25–90)
40 (30–75)
S UMMARY OF THE literature review for exposed
EFTR with endoscopic closure is listed in Table 1.
Zhou et al. reported 26 EFTR for cases of gastric GIST
originating from the muscularis propria (MP).14 R0 resec-
tion was achieved in all tumors that had a median size of 28
(range 12–45) mm. Resected opening of full-thickness layer

12.1 (6–20)
size (mm),

28 (12–45)

24 (13–35)

20 (10–33)
22 (6–40)
24 (8–60)
median
(range)
Lesion

was successfully closed by Endoclips in all cases even when

the defect was larger than 30 mm.
Guo et al. reported 23 cases of exposed EFTR followed
by defect closure with the OTSC system. EFTR was
No. patients

26

23

51

30/21/11
successfully carried out (100%) and delayed perforation was
not observed even 3 months after EFTR. Tumor size was
12.1  4.7 (range 6–20) mm. In the pathological findings,
one case was high-risk GIST (4%), 18 (78%) were very-
Table 1 Summary of studies in the present review

low-risk GIST, and 4 (17%) were leiomyomas. Fever

curvature (EFTR/clip-
SMT in the fundus

assisted method)
or in the lesser

(>37°C) was observed in three cases (13%) on the operation method/loop-

from the MP
MP <20 mm
Gastric SET,

with-thread
SET arising
Indication

SMT, MP

day and in one case (4%) on the day after EFTR. Localized
peritonitis occurred in two patients (9%). There was neither
delayed bleeding nor delayed perforation.15
Ye et al.16 evaluated the safety and efficacy of EFTR
(n = 51) with defect closure using clips and an endoloop for
resection of gastric subepithelial tumors (SET) of the MP.
Retrospective,

Retrospective,

Retrospective,

Retrospective,
Study design

single center

single center

single center

single center
and setting

EFTR was successfully carried out in 50 patients (98%).

Mean operation time of EFTR was approximately 52 min.
Sarker et al. reported that eight patients with submucosal
neuroendocrine tumors (NET) were successfully resected.
Mean size of the lesions was 13.4 (range 9–20) mm.
Zhou et al.

Guo et al.

Ye et al.

Although complete resection was achieved in seven of eight

Lu et al.
(2011)14

(2015)15

(2014)16

(2016)19
Author

patients (87.5 %), full-thickness resection was achieved in

two of eight patients (25.0 %).17 In contrast, Gluzman et al.

© 2018 Japan Gastroenterological Endoscopy Society

Digestive Endoscopy 2018; 30 (Suppl. 1): 25–31
reported two delayed perforations after application of OTSC
closures. Hence, they recommended laparoscopic closure of
artificial perforations after EFTR, and concluded that
laparoscopic and endoscopic surgery is safe and feasible
for resection of the gastric GIST.18
Lu et al. compared the outcomes of three methods of EFTR:
conventional method, thread-with-clip method and loop-
assisted method in 62 cases of submucosal tumors (SMT) of
the gastric fundus. They reported that operation time was
significantly shorter in both thread-with-clip and loop-assisted
methods than the conventional method.19 Median lesion size
was approximately 2 cm. As sufficient traction using the clip-
with-thread or the loop-assisted method made it possible to
carry out EFTR successfully (97%) in this study, the EFTR
procedure was carried out by experienced endoscopists in the
high-volume center. Hence, it cannot be affirmed that EFTR is
easy to carry out in the technical aspect (Table 1).
Indication for conventional exposed EFTR
In all studies, GIST was a good indication for EFTR. GIST
is a good indication for EFTR because: (i) local resection
only without lymphadenectomy, such as in EFTR, is a
sufficient surgical procedure for GIST; (ii) the resection
margin can be easily determined from inside the gastric
lumen; and (iii) most importantly, there is no risk of tumor
cell dissemination unless the capsule is damaged. The
resected specimens can be retrieved through the mouth at a
largest diameter of approximately 3 cm.20,21
Sizes of the lesions
Mean tumor size of all four studies was 20.71 mm. One of
the reasons for mean tumor size of approximately 2 cm was
because the resected tumors had to be retrieved through the
esophagus and mouth. Lesion size in Schmidt’s study was
larger than for the other studies because it included
adenomas and early carcinoma in the colon, whereas the
others included gastric SMT or SET only.8 In general,
indication for EFTR was lesions smaller than 30 mm in
diameter. Endoscopic ultrasonography (EUS) was carried
out as a standard method to make a diagnosis of SMT.
Computed tomography (CT) was also done to evaluate any
metastasis. Although sampling by EUS-fine-needle aspira-
tion (EUS-FNA) does not guarantee a definite diagnosis in
all cases, EFTR can provide a definite diagnosis by
complete histological examination of the resected specimen.
Closure devices and complications
In two studies, endoclips were used to close the resected
opening without any complications,14 whereas the other two
Endoscopic full-thickness resection 27
studies reported complications such as delayed perforation
even using OTSC, which has stronger grasping power than
conventional endoclips.15 Therefore, we suspect that closure
of the resected opening is still skill-dependent. Metallic clips
have been used to close the perforation of the digestive tract
and is useful for small perforations, but has technical
limitations for large defects. To solve such a problem, Ye
et al. used endoloops to obtain strong closure and ligature in
combination with endoclips.16 Lu et al. developed and
reported a new method of defect closure using traction
devices: clip-with-thread method/loop-assisted method.
These methods avoid poor endoscopic visibility by collapse
of the lumen. Moreover, as a large resected opening can be
narrow because of traction, closure of the resected site
becomes easy.17 Guo et al. used a combination of OTSC
system and metallic clips to completely close the resected
opening and reported promising results.15
Procedure times
Procedure times were reported from a minimum of 40 min
to a maximum of 105 min. Considering the operation time
of laparoscopic partial gastrectomy, procedure time of EFTR
(maximum 105 min) is acceptable. Many factors such as
tumor size, location, and experience of operator may affect
the procedure time.
Introduction of newly developed EFTR
procedure (non-exposed EFTR)
Endoscopic mucosal resection for adenoma or early col-
orectal carcinoma with severe fibrosis increases risk of
perforation and other adverse events.3 Perforation rate of
ESD for lesions with severe submucosal fibrosis is reported
to be 3.6%.2
Schmidt et al. developed FTRD as one of the EFTR
devices, which enables subsequent procedures of lesion
grasping, full-thickness suturing by OTSC, and snare
resection in one session.8 The FTRD procedure consists
of: (i) mount of modified OTSC cap with snare to a standard
colonoscope; (ii) insertion of the colonoscope with FTRD;
(iii) insertion of a grasping forceps through a working
channel; (iv) grasping and pulling of the lesion with the
bifold full-thickness colonic wall into the cap; (v) release of
OTSC; and (vi) full-thickness resection of the bifold colonic
wall by a loaded snare.10 A prospective multicenter study
including nine German hospitals (181 patients) evaluated
efficacy and safety of EFTR using FTRD.9 FTRD showed
an overall technical success rate of 89%, R0 resection rate of
77% for non-lifting-sign-positive adenomas and early car-
cinoma, and subepithelial tumors. For lesions confined to
© 2018 Japan Gastroenterological Endoscopy Society
28 H. Mori et al.
shallow submucosa (adenoma and superficial adenocarci-
noma), R0 resection rate was 76%, whereas eight lesions
with massive submucosal invasion showed a complete
resection rate of 44.8% only. R0 resection rate of 23 SET
was 87.0%, and it was higher (80%) in small (<2 cm)
lesions compared to that in lesions 2 cm or larger (58%).
FTRD was feasible and safe especially when lesions were
benign colorectal neoplasms smaller than 2 cm. EFTR using
FTRD is safer and more rapid than other treatments such as
ESD for the treatment of difficult colorectal lesions. In
EFTR using FTRD, it was reported that procedure times for
advancing the FTRD device to the lesion was a median of
10 min (range 1–50) (min), resection time 5 min (1–90) and
total EFTR procedure time was 50 min (3–190).8
Some limitations of FTRD include: (i) difficulty of
resection for lesions larger than 25 mm as the size of the
aspiration cap is about 13 mm in diameter; (ii) insufficient
endoscopic view during the procedure because of long cap;
and (iii) damage to the superficial mucosa of the specimen
with grasping forceps making histological assessment
difficult.9
STER is one of the EFTR techniques to use submucosal
tunnel to avoid air/content leakage outside the lumen. Ye
et al. reported a prospective study of STER.22 STER
procedure is as follows: (i) creation of a submucosal tunnel
from 5 cm proximal to the tumor; (ii) removal of the tumor
using ESD technique and snare; (iii) closure of the
submucosal entrance with hemoclips. Eighty-five patients
with upper gastrointestinal SET (60 esophageal and 25
gastric lesions) underwent STER successfully. The opera-
tion took about 60 min for tumors with a mean size of
20 mm. Final histology showed leiomyoma (76%), GIST
(22%), and others (2%). Total complication rate was 26.3%
for GIST and 4.6% for leiomyomas (P < 0.05).22 Most
(76%) patients with esophageal leiomyoma did not have
any symptoms and the tumor was smaller than 20 mm;
however, eight patients (9.4%) developed pneumothorax,
subcutaneous emphysema, and pneumoperitoneum. Thus,
from the perspective of risk benefit, application of indica-
tion and outcome in this study into standard practice is
controversial.23 Endoscopic submucosal tunnel dissection
(ESTD) similar to STER was reported in several articles.
Gong et al. reported ESTD for 12 patients with SMT in the
esophagus and cardia. Mean tumor size was approximately
20 mm, and mean procedure time was about 50 min.
Complications including pneumothorax have been reported
in two patients (16% cases). From the safety point of view,
the procedure is not yet safe.24–26 Clinically relevant
indication and effective management for complications
should be established to carry out the STER procedure in
clinical practice.
© 2018 Japan Gastroenterological Endoscopy Society
Digestive Endoscopy 2018; 30 (Suppl. 1): 25–31
Presentation and development of a new
suturing device in Japan
Currently, the only commercially available full-thickness
suturing device using suturing threads for flexible endo-
scopy is the Overstitch System (Apollo Endosurgery,
Austin, TX, USA). However, it requires a two-channel
endoscope. Moreover, OTSC has been commercially avail-
able for conventional one-channel flexible endoscopy but it
is a clip-type closure device. Accordingly, no full-thickness
suturing device that can be attached to a common flexible
endoscope has so far been developed.
Recently, Mori et al. developed a full-thickness suturing
device, double-armed bar suturing system (DBSS), which
can be used for conventional one-channel flexible endo-
scopy and provides the same suturing strength to surgical
hand-sewn sutures.27 DBSS is easily attached as a hood
attachment to the tip of a conventional flexible endoscope
(Fig. 1). DBSS does not use the original working channel of
the endoscope, and it remains usable for other purposes.
The basic endoscopic maneuver in the DBSS procedure is
parallel movement of the first arm only, which has suturing
surgical thread, and the second arm with the puncture
needle is moved by handle movement of the device. In
DBBS, circumferential mucosal incision is initially made
with a Dual knife (KD-650L; Olympus Co., Tokyo, Japan)
(Fig. 2a). Then, the muscularis propria is gradually and
carefully cut with the Dual knife (Fig. 2b). After a small
perforation hole is made, circumferential full-thickness
resection is done with an IT knife 2 (KD-612; Olympus
Co.) (Fig. 2c,d). To suture the defect, the first arm with a
Figure 1 Double-armed bar suturing system (DBSS). DBSS
is composed of sheath, control handle and attachment
hood parts.
Digestive Endoscopy 2018; 30 (Suppl. 1): 25–31 Endoscopic full-thickness resection 29

(a) (b)

(c) (d)

(e) (f)

(g) (h)

Figure 2 Endoscopic full-thickness resection and full-thickness suturing with double-armed bar suturing system (DBSS). (a)
Circumferential mucosal incision after creation of 45-mm pseudolesion in the greater curvature of the gastric body. (b) Gradual
and careful cutting of the muscularis propria with Dual knife (Red arrows). (c,d) Circumferential full-thickness resection with IT
knife 2 from the artificial perforation hole (yellow arrow). (e) Insertion of the first arm into the serosal side of the gastric wall
(yellow arrow) on the left side of the resected opening, and advancement of the second arm with puncture needle through the
gastric wall to connect it with the tiny attachment of the first arm (red arrow). (f) Rotation of the second arm to the right side of
the resection opening, and advancement of the second arm through the gastric wall in the same way to the left side (yellow
arrow). (g) Tie up of both edges of the resection opening with surgical thread at the center of the puncture needle (blue arrows).
(h) Complete closure of the resected opening with seven full-thickness sutures with 3–4-mm interval.

© 2018 Japan Gastroenterological Endoscopy Society

30 H. Mori et al.
Table 2 Results of GLP examination of EFTR procedure using DBSS in five porcine models
No. EFTR Median resected Median Median no.
procedures specimen size full-thickness full-thickness
of EFTR (mm) resection suturing (times)
time (min)
n=5 45 30
DBSS, double-armed bar suturing system; EFTR, endoscopic full-thickness resection; GLP, good laboratory practice.
tiny connector of the DBSS is inserted on the left side of the
resection opening into the serosal side of the gastric wall,
the second arm with a puncture needle is advanced forward
through the gastric wall, and the second arm is connected to
the tiny attachment of the first arm (Fig. 2e). DBSS has a
very tiny connector with an absorbable suture thread
weaved into it on both sides at the end of the first arm.
The second arm equipped with a penetrating needle is
inserted into the gastric wall and connected to the connector
of the first arm. The second arm is rotated to the right side
of the resection opening and, again, it is advanced forward
through the gastric wall in the same way (Fig. 2f). With
these steps, both edges of the resection opening are tied
with surgical thread (Fig. 2g). The full-thickness suture is
continued with a 3–4-mm interval until complete closure of
the resection opening is achieved (Fig. 2h). The first arm
also functions as a stopper to prevent injuries to adjacent
organs. DBSS suture showed similar strength to hand-sewn
suture (P = 0.542): median (95% CI) air leak pressure of
DBBS versus hand-sewn suture = 3665 (1600–4400) Pa
(G) versus 3350 (2470–4250) Pa (G).27
The safety of DBSS regarding materials, mechanism and
procedures has been tested as good laboratory practice
(GLP) examination in accordance with Pharmaceutical
Affairs Law (article 43) at Tsukuba Research Center of
Hamri Co., Ltd, Ibaragi prefecture, Japan under consultation
to the Pharmaceuticals and Medical Devices Agency
(PMDA), Tokyo, Japan. For EFTR procedures using DBSS,
success rate, safety, blood loss, procedure time of EFTR,
and histological findings after the procedure were evaluated
in five porcine models. The results of the EFTR procedures
using DBSS are shown in Table 2. The full-thickness
resection took a median procedure time of 30 min. A total of
9–12 times suturing was required to close median resected
specimen size of 45 mm with median total suturing time of
77 min (8.25 min for each suturing). All swines survived
for 14–60 days until the day of death.
FUTURE PERSPECTIVES
A LTHOUGH THE EFTR procedure is still developing
and requires refinement, from a viewpoint of
© 2018 Japan Gastroenterological Endoscopy Society
Digestive Endoscopy 2018; 30 (Suppl. 1): 25–31
Median time Median time Total malfunction
for total for one of suturing
suturing (min) suturing (min) device (times)
9 77 8.25 3
invasiveness, it is an excellent procedure compared to
surgery of lesions in the digestive tract. Development of
reliable closure devices and establishment of appropriate
indications make EFTR more practical and it would
contribute to reduction of financial, physical and psycho-
logical burdens of patients with lesions involving the
digestive tract wall.
ACKNOWLEDGMENT
T HE AUTHORS ACKNOWLEDGE Dr Makoto Oryu
for supporting this study.
CONFLICTS OF INTEREST
A UTHORS DECLARE NO conflicts of interest for this
article.
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© 2018 Japan Gastroenterological Endoscopy Society