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99
8 Access: Transgastric
to adjacent extramural structures. The surgeon has to take into account the anat-
omy and vascularization of the stomach [ 9 ] , accessibility to the target organ [ 10 ] ,
and the technical possibility to properly close the port after the surgical
procedure.
Techniques of Gastrotomy
PEG Technique
The PEG-like approach to the peritoneal cavity, described by Kantsevoy et al., is
a modi fi cation of the traditional endoscopic insertion of a percutaneous gastros-
tomy tube developed and introduced into the clinical practice by Gauderer and
Ponsky [ 2, 11 ] .
A gastroscopy is performed to identify the anterior stomach wall. Transillumination
of the anterior abdominal wall allows the surgeon to exclude the interposition of any
organs between the stomach and the anterior abdominal wall. Digital pressure is
applied to the abdominal wall, which the endoscopist can see indent the anterior
gastric wall. A small (21-gauge, 40-mm) needle is passed percutaneously into the
stomach and a soft guidewire is inserted through this, grasped by an endoscopic
snare or grasper, and pulled through the biopsy channel of the endoscope. A sphinc-
terotome or a needle-knife is inserted into the gastric wall over the guidewire.
A gastric incision is performed. The incision can be large (1–1.5 cm) to allow the
direct passage of the endoscope, or small (0.5 cm) and dilated with an 18–20-mm
through-the-scope balloon. The latter is less traumatic, splitting instead of cutting
the muscular layers. This technique is unlikely to cause bleeding and may facilitate
closure as the muscles tend to recoil back snugly around the scope. On balloon
semide fl ection, the endoscope is pushed forward and passed through the gastric
wall (Fig. 8.1 ).
The limitation of the PEG-like approach is that the gastric incision is usually
located on the anterior gastric wall. This location may not be optimal for certain
procedures. The PEG-like transgastric approach to the peritoneal cavity is techni-
cally simple and safe and will allow incision of the gastric wall and entrance to the
peritoneal cavity without a signi fi cant risk of damage to adjacent organs.
Linear Incision with a Needle-Knife
Advancing a needle-knife through the gastric wall performs a 1-cm incision.
Electrocautery is discontinued immediately upon tactile perception of full-thickness
puncture. The metallic tip of the needle-knife is then retracted and the catheter
pushed through the gastrotomy and used as a guide to advance the video gastro-
scope into the peritoneal cavity.
100
B. Dallemagne et al.
Fig. 8.1 Transgastric access
by a PEG-like technique in an
animal model
101
8 Access: Transgastric
An alternative is to perform a 0.5-cm incision and, after removing the needle-
knife, an esophageal dilating balloon is used to radially dilate the incision into an
18-mm circular gastrotomy. The endoscope is then advanced through this opening
and into the abdominal cavity.
This technique has the theoretical advantage of being performed in different sites
of the stomach. But it carries a high risk of injury to adjacent organs because it is
totally blind. In their review of 73 transgastric experimental procedures on pigs,
Sohn and colleagues reported that 15.5 % of the traditional transgastric needle-knife
NOTES gastrotomies performed without laparoscopic visualization caused some
type of intraabdominal injury [
12 ] .
In the clinical setting, this method of small gastrotomy with guided balloon dila-
tion under laparoscopic visual control by means of a 5-mm rigid laparoscope intro-
duced in an umbilical trocar is used by the majority of teams performing transgastric
surgery [ 13– 15 ] . It was successfully utilized in a series of transgastric cholecystec-
tomies [ 16 ] . An endoscopic monopolar needle-knife was used to create a 0.5-cm
gastrotomy on the anterior gastric wall in the antrum of the stomach. A guidewire
was passed through the gastrotomy to guide an 18-mm balloon dilator, which
expanded the gastrotomy and allowed for the passage of a double-channel gastro-
scope (Fig. 8.2 ). Neither bleeding nor injuries to adjacent organs were observed.
With growing experience, some teams have started to perform the transgastric
approach without laparoscopic surveillance [ 15 ] .
The only technology currently available to visualize the surrounding structures
when performing a transgastric approach is endoscopic ultrasound. In a study com-
paring anterior and posterior needle-knife gastrotomies performed with and without
ultrasound control, Elmunzer et al. identi fi ed clinically signi fi cant complications,
including liver laceration, spleen laceration, gallbladder puncture, pancreatic lacer-
ation, and kidney puncture in all “unsafe” approaches, while all the ultrasound-
guided gastrotomies were uneventful [ 17 ] .
Submucosal Flap Technique
Another seductive approach is the submucosal fl ap technique that was developed in
a bid to control peritoneal contamination and facilitates closure of the gastrotomy
(Fig. 8.3 ).
Moyer et al. described the self-approximating transluminal access technique
(STAT) [ 18 ] . By using an injection needle, 10 ml of normal saline solution is intro-
duced submucosally to elevate the mucosa from the underlying muscle in the poste-
rior cardiac portion of the stomach. A 1–1.5-cm incision is then created in this
submucosal cushion with a needle-knife. A grasping forceps is used to continue the
dissection of the loose areolar tissue in the submucosal plane, separating the mucosa
from the adjacent circular muscle layer. By using a combination of sharp and blunt
dissection with the forceps, as well as blunt and pneumatic dissection with the lead-
ing edge of the endoscope, an extended submucosal tunnel (10–12 cm) is created.
102
B. Dallemagne et al.
Fig. 8.2 Transgastric access by gastric puncture and balloon dilation
103
8 Access: Transgastric
A needle-knife is used to incise the seromuscular layer at the distal end of the sub-
mucosal tract. This allows the endoscope to advance from the tunnel and achieve
transluminal access. At the end of the procedure, the muscosa is closed with endo-
scopic clips. In a survival study, the authors achieved excellent closure of the gas-
trotomy but reported abscess in the submucosal tunnel in one animal, and in the
peritoneal cavity in another animal (2/5: 40 %) [ 19 ] .
The submucosal tunnel is not as long in the submucosal endoscopy with mucosal
fl ap safety valve (SEMF) technique described by Sumiyama et al. [ 20 ] . High-
pressure CO
2
is injected into the submucosal layer through a standard 23-gauge
injection needle to create a submucosal gas cushion (greater than 10 cm in diameter).
Hydroxypropyl methylcellulose is then injected to prevent gas escape and to main-
tain the cushion. A mucosal incision (10 mm) is made at one margin of the cushion
with a bipolar needle-knife; a 15-mm biliary retrieval balloon is repeatedly inserted
into the insuf fl ated submucosal layer from the mucosal incision and is distended to
dissect strands of connective tissue to create a space to easily insert the endoscope
with the attached EMR cap. The length of the submucosal space is 65–80 mm.
Opposite the mucosal entry point and within the submucosal space, the muscular
layer is resected by cap EMR. The mucosal incision is closed by mucosal apposition
Mncosa
a
b
c
Submncosal layer
circular muscle layer
longitudinal muscle layer
Serosa
Fig. 8.3 Submucosal fl ap technique for transgastric access ( a ) lifting of the mucosa by injecting
saline ( b ) submucosal tunel ( c ) submucosal gastrotomy
104
B. Dallemagne et al.
with metal clips or T-tags. In an animal survival study, all gastrotomies were suc-
cessfully created, but complications were encountered in the pig, where a posterior
site was chosen [ 21 ] .
Unlike Sumiyama, Pauli et al. [
22 ] do not resect the sero-muscular wall but incise
it, and Yoshizomi uses a balloon dilation of the incision [ 23 ] . Both groups reported
excellent results in animal survival studies.
The issue of the retrieval of organs through this submucosal channel was recently
addressed, and a study suggests STAT will tolerate the mechanical forces of peroral
transgastric procedures provided the organ resected is small to moderate in size
(<8 × 3 cm) [
24 ] .
What Is the Best Technique?
The literature presents many techniques for gastrotomy creation, which can be
classi fi ed into three main types: direct approach with a gastric linear incision with a
needle-knife/sphincterotome; direct approach with a gastric wall puncture with a
needle-knife and balloon dilation of the puncture and indirect approach via a sub-
mucosal tunnel. The type of approach can in fl uence the technical dif fi culty of the
procedure, potential complications, access to certain quadrants of the abdomen,
and, of course, the quality of the closure of the gastrotomy.
Von Delius et al. compared the three types of gastrotomy creation in ex vivo
stomachs [ 25 ] . The submucosal fl ap technique was divided into two subgroups, one
with a short tunnel (4 cm), and a group with an extended tunnel (8 cm). They closed
all the gastrotomies/mucosal fl aps with clips and measured the operative time and
the leak pressures obtained with the different technical variations. Extended submu-
cosal tunneling required the longest operative time, showed the highest leakage
pressures, and resulted in twice as strong a closure of the gastrotomy, as observed in
the group with balloon dilation ( P = 0.002).
One major question is the ideal site of gastric access for visualization of different
organs in humans. Similar to the varied port placements used in laparoscopic sur-
gery, certain gastric sites of access are likely to be better suited for visualization and
manipulation of certain abdominal organs. Nikfarjam et al. addressed this problem
in a series of transgastric peritoneoscopy in human [ 10 ] . The site for NOTES gas-
trotomy was the body in three cases, the lesser curvature in three cases, the greater
curvature in one case, the fundus in one case, and the antrum in one case. The endo-
scope provided satisfactory navigation to and visualization of the right upper quad-
rant, both lower quadrants, and the anterior abdominal wall. Visualization of the left
upper quadrant, particularly visualization of the spleen, was problematic and could
be satisfactorily achieved in only one of nine cases (11 %). It was possible in one
case where the site of gastrotomy was at the greater curvature in the midbody of the
stomach. Hazey et al. reported on ten human cases where transgastic NOTES was
performed as part of diagnostic endoscopy in patients with pancreatic cancer [
13 ] .
The site of gastrotomy in that series was in the anterior antral region, so that it could
be incorporated into a gastrojejunostomy in cases where patients were deemed to be
105
8 Access: Transgastric
unresectable. In their report, four of ten patients had inadequate visualization of the
right upper quadrant, whereas all ten were reported to have good visualization of the
left upper quadrant. These fi ndings differ from the previous study, possibly due to
the more distal gastric access site chosen, which allows greater retro fl exion of the
endoscope to view the left upper quadrant while providing a straighter path to
clearly visualize the right upper quadrant.
In cholecystectomy, most teams use an anterior body-antrum site for the gastro-
tomy that allows “comfortable” access to the gallbladder [
14– 16 ] . However, speci fi c
anatomical distortions, along with the lack of exposure provided by present meth-
ods of retraction and retro fl exion, tend to distort Calot’s triangle by fl attening it
rather than opening it up, exposing it to anatomical misinterpretation [ 26 ] .
Closure of the Gastrotomy
The Natural Ori fi ce Surgery Consortium for Assessment and Research clearly states
that gastric closure is an important issue that needs thorough assessment. There is
general agreement that there must be near-zero tolerance for leaks. The ideal clo-
sure should be rapid, reproducible, and safe, ideally performed under vision to avoid
any injury to the adjacent organs, and should grant a full-thickness bite.
Although some authors performed experiments in survival animal models with-
out gastric closure at all, without the development of peritonitis or sepsis, there is
general agreement that a secure closure with a minimal risk of leak must be achieved
to avoid major complications [ 27 ] .
To date, a variety of endoscopic techniques have been described to close gastric
wall incisions, including the application of endoscopic clips, endoloops, tissue
anchoring systems, endoscopic suturing, stapling, and occluding devices (Table 8.1 ).
Objective and analytic evaluation of the results is complex. The security of closure
is estimated by different parameters in in vivo and ex vivo studies. In ex vivo stud-
ies, results using burst pressure as a surrogate marker of a leak-proof suture are
dif fi cult to extrapolate. Most of the survival studies were performed on a porcine
model, which presents several drawbacks. Experience shows that the pig response
to infection and in fl ammation may be unpredictable, with a frequent mismatch
between the clinical outcome and the presence of peritoneal infection.
The tested devices re fl ect two different philosophies: The endoscopic attitude of
closing the visible defect by approximating the mucosal edges with clips opposes the
surgeon’s tendency to reproduce the hand-sewn suture with a full-thickness closure.
EndoClips™ (Olympus Optical Co., Ltd., Tokyo, Japan)
The simple application of current endoclips enables only a single-layer mucosal
approximation. In addition, their application might be dif fi cult at times due to a
tangential orientation of the tissue or because of tissue edema. Kalloo et al. used this
106
B. Dallemagne et al.
Table 8.1 Summary of NOTES gastrotomy closure techniques
Author Device technique N Type Burst Leak
Voermans [
28 ] OTSC 16 Surv 0
Romanelli [
29 ] LAPS 4 Surv 0
Desilets [
30 ] Padlock-G™ (Aponos
Medical, Kingston, NH)
4 Surv 0
Dray [
31 ] Resolution
®
clips (Boston
Scienti fi c, Natick, MA)
T-tags
4 Surv 0
8
Bergman [
32 ] Plug 12 D Surv 77 0
No CLOSURE 11 D 76
Romanelli [
33 ] Padlock-G™ (Aponos
Medical, Kingston, NH)
8 Ex vivo 68
Asakuma [
34 ] Per-oral dual scope 6 Surv 1/6, 16 %
Park [
35 ] Tissue apposition system 16 Surv 0
Suture laparotomy 16
Willingham [
36 ] Resolution
®
clips (Boston
Scienti fi c, Natick, MA)
(T-tags in case of leak)
36 Surv 4/36, 11 %
Hucl [
37 ] Double endoloops 10 Surv 160 0
Sherwinter [
38 ] SurgASSIST
®
(Power Medical
Interventions, Langhorne,
PA) (circular stapler)
15 Ex vivo 260 0
5 Surv
Pauli [
22 ] Directed submucosal
tunneling + Resolution
®
clips (Boston Scienti fi c,
Natick, MA) (STAT)
14 Surv 0
Von Renteln [
39 ] OTSC 10 Surv 0
Clips 10
107
8 Access: Transgastric
Author Device technique N Type Burst Leak
Voermans [
40 ] OTSC 11 Ex vivo 233
Hand-sewn 15 206
Desilets [
41 ] LAPS 9 Ex vivo 27.3
Clips 9 14
Rolanda [
42 ] OTSC 15 Surv 2/15, 13.3 %
Von Renteln [
43 ] OTSC 18 Acute 83 (30–140)
Suture 18 67 (30–130)
Hookey [
44 ] Queen’s closure (clips + loop) 5 Surv 0
Ujiki [
45 ] Gastric valve (HUMAN
STUDY)
10 P Surv 0
5 M
Moran [
46 ] Endoscopic suturing device ? ? ? ?
Trunzo [
47 ] Tissue anchors 5 Acute
Bhat [
48 ] Endoscopic tacks 6 Surv 0
Dray [
49 ] Omentoplasty 6 Surv 1/6
Kratt [
50 ] OTSC 9 Acute 5/9
? - not specifi ed
108
B. Dallemagne et al.
technique in the seminal report on transluminal surgery. At necropsy, intraperito-
neal abscesses were found in two of fi ve animals. Alternative methods that use cur-
rent endoscopic clips were developed to obtain full-thickness gastric closure. Using
two endoscopes to provide a layer-by-layer endoscopic clip closure was proposed
by Asakuma et al., who reported minor intraperitoneal infection in two of fi ve ani-
mals in a survival study [
34 ] . Hwang et al. described a retracted clip-assisted gastro-
tomy closure technique that involves deploying three or four clips (modi fi ed by
attaching a 90-cm length of suture string to the end of each clip) along the margin
of the gastrotomy with one jaw on the serosal surface and the other jaw on the
mucosal surface. The suture strings are then threaded through an endoloop. Traction
is then applied to the strings, causing the gastric wall to tent. The endoloop is then
secured below the tip of the clips, completing a full-thickness gastrotomy closure
[ 51 ] . In Katsarelias’s technique with endoloops, the incisional margins are sepa-
rately grasped in their center, elevated, and looped, with care taken to include all
layers except the serosa. The two loops are then grasped and elevated, and a third
loop is applied encompassing the entire length of the incision and tied down [ 52 ] .
In a study of the effectiveness of gastrotomy closure comparing the Katsarelias
technique, endoclips, and hand-sewn closure as a control, Shabbir et al. concluded
that endoclip closure endured a signi fi cantly higher median pressure before leaking
compared to that of an endoloop [ 53 ] .
A new concept of endoscopic clip, the OTSC™ (over-the-scope-clip, Ovesco
Endoscopy GmbH, Tübingen, Germany) was recently adapted and tested for clo-
sure of the gastrotomy. The applicator is mounted onto the distal tip of the endo-
scope. A clip is installed onto the system in a bent state and can be released by a
wire, which is led through the working channel. When released from the applicator,
the shape-memory effect and the high grade of elasticity of the clip nitinol alloy
cause closure of the clip [ 54 ] . The system was tested in nonsurvival and survival
animal studies and compared favorably with surgical suture while showing higher
ef fi ciency than current endoscopic clips [ 39, 40, 42, 43, 50, 55, 56 ] .
Suturing Devices
Accurate stitch placement, control of the needle insertion depth, and knot tying are
the basic steps that still challenge any endoscopic attempt at suturing in NOTES.
Novel suturing devices and techniques have been developed, and some of them are
now commercially available and used in clinical applications. In 2003, Swain’s
team proposed a method consisting of a series of double tags that are positioned
around the defect, through the wall, to be then approximated in pairs, and locked at
the same time by various locking mechanisms [ 57 ] . This uses a fl exible endoscopic
hollow needle to deliver a threaded tag through tissues. Endoscopic gastrotomy
closure with T-tags is technically simpler than with clips, allows a tight leak-proof
approximation of the gastric wall opening, and can withstand higher intragastric
bursting pressure than closure achieved with the clips [ 58, 59 ] . The full-thickness
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