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SECTION 1 Development of the NOTES Concept
https://t.me/med1917
eHealth project PASSPORT. The NOTES and SILS works
have been co -funded by the French Minister of industry, the
Alsace land, the Oseo Anvar organization, and the European
FEDER funds in the Anubis and ISIS projects.
Chapter video clips
Video 9.1 Pre-operative virtual patient modeling and intraop-
erative augmented reality surgical guidance.
Video 9.2 Automatic NOTES endoscope tracking and real -time
3D visualization of its shape.
Video 9.3 Robotization of NOTES fl exible endoscope and
instrumentation including automation.
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43 Lehman AC, Dumpert J, Wood NA, et al. Natural orifi ce chole-
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103
2
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Current Clinical Applications
and Techniques
10
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NOTES for Peritoneal Exploration
Seigo Kitano & Kazuhiro Yasuda
Oita University Faculty of Medicine, 1 -1 Idaigaoka, Yufu, Oita, Japan
Introduction
Natural orifi ce translumenal endoscopic surgery (NOTES)
represents the next logical step in the evolution of minimally
invasive surgery that aims to reduce the impact of surgical
access [1–7]. Many experimental studies have shown the
technical feasibility of performing various surgical procedures using the NOTES technique [8–13], and experience
with NOTES in humans has gradually been increasing [14–
19]. However, the safe adoption of NOTES for complex
surgical procedures will require development of such tools
as an endoscopic suturing device, an endoscopic anastomotic
device, and a multitasking platform. Peritoneoscopy appears
to be one of the most optimal NOTES procedures that can
be performed with currently available devices.
This chapter summarizes the published data on NOTES for
peritoneal exploration and describes the technical details of
the performance of natural orifi ce transgastric endoscopic
peritoneoscopy with the submucosal tunnel technique.
NOTES peritoneoscopy
Experimental studies
Several studies have evaluated the feasibility of NOTES peritoneoscopy using various translumenal routes (Table 10.1)
[8,20–29]. In 2004, Kalloo et al. fi rst reported natural orifi ce
transgastric peritoneoscopy using a fl exible endoscope in
porcine models [8]. Transgastric access to the peritoneal
cavity was made by needle -knife puncture, followed by
extension of the puncture site with a dilation balloon or a
sphincterotome. After endoscopic peritoneoscopy using
insuffl ations with air, the gastric incision site was closed with
endoclips. Twelve acute and fi ve survival experiments were
successfully performed without complications. Subsequent
study confi rmed the feasibility of this technique and showed
the ability of transgastric endoscopy for peritoneal exploration to identify most intra -abdominal organs in 15 pigs [20].
Safe peritoneal access and secure access site closure are
the most important concerns in NOTES, and a more reliable
technique for peritoneal approach has been required. Several
investigators have shown the effectiveness of transgastric
peritoneoscopy via a submucosal tunnel. Sumiyama et al.
developed the submucosal endoscopy with mucosal fl ap
safety valve technique [21]. They created a large submucosal
working space for insertion of an endoscope using high pressure carbon dioxide (CO
tion, resected the seromuscular layer by using an endoscopic
mucosal resection (EMR) cap, and closed the mucosal entry
site with endoclips. Access to the abdominal cavity and peritoneoscopy were successfully performed in all four survival
pigs. Although necropsy at seven days revealed ulceration
on the gastric submucosal working space in three pigs and
a small bowel injury in one pig, the leak test was negative
in all stomachs. Pauli et al. reported the safety and feasibility
of transgastric peritoneoscopy through an extended submucosal tunnel with a length of 10 –12 cm [22]. The extended
submucosal tunnel was created by using a rat -tooth grasping
forceps and blunt dissection with the endoscope, and the
seromuscular layer was incised at the distal end of the submucosal tunnel with a needle -knife. After examination of
the peritoneal cavity, the gastric mucosal incision was closed
with endoclips. This technique was successfully performed
in all fi ve animals, of which two animals had submucosal
abscess without clinical symptoms. Our group demonstrated
the usefulness of transgastric peritoneoscopy with a submucosal tunnel using the endoscopic submucosal dissection
(ESD) technique in a porcine survival model [23]. The
ESD technique was useful for making the narrow 5 cm long
) injection and balloon dissec-
2
Natural Orifi ce Translumenal Endoscopic Surgery (NOTES): Textbook and Video Atlas, First Edition. Edited by Anthony N. Kalloo, Jacques Marescaux,
Ricardo Zorron.
© 2012 John Wiley & Sons, Ltd. Published 2012 by John Wiley & Sons, Ltd.
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SECTION 2 Current Clinical Applications and Techniques
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Table 10.1 Experiments in NOTES peritoneoscopy.
Authors Year Model Type of study N Complications
Transgastric
Kalloo et al. [8] 2004 Porcine Acute and survival experiments 17 None
Wagh et al. [20] 2005 Porcine Acute and survival experiments 15 None
Sumiyama et al. [21] 2007 Porcine Ex vivo and survival experiments 4 1 (Small bowel injury)
Pauli et al. [22] 2008 Porcine Acute and survival experiments 7 None
Yoshizumi et al. [23] 2009 Porcine Survival experiment 7 None
Trunzo et al. [24]
Transcolonic/rectal
Fong et al. [25] 2007 Porcine Survival experiment 6 None
Wilhelm et al. [26] 2007 Porcine Acute and survival experiments 8 None
Ramamoorthy et al. [27] 2009 Porcine Acute experiment 3 None
Transvesical
Lima et al. [28] 2006 Porcine Acute and survival experiments 8 None
Branco et al. [29] 2010 Male cadaver − 2 −
2010 Porcine Acute experiment 15 None
submucosal tunnel, and transgastric endoscopic peritoneoscopy with a submucosal tunnel was successfully performed
with no complications in all seven survival pigs. These
experimental studies have shown that the submucosal
tunnel technique provides safe transgastric abdominal access
and reliable closure for NOTES peritoneal exploration with
currently available devices.
The diagnostic effi cacy of transgastric peritoneoscopy was
examined by Trunzo et al. [24]. In their study, four pathologic lesions, including small bowel ischemia, small bowel
perforation, colonic perforation, and simulated gangrenous
cholecystitis, were created in fi fteen porcine models, and
these animals were randomized for attempted identifi cation
of these lesions by both transgastric and laparoscopic exploration. Although laparoscopic exploration was more sensitive than transgastric NOTES peritoneoscopy (77% versus
61%), NOTES was 100% specifi c with 100% positive predictive value compared with values of 93% and 92%, respectively, for laparoscopy.
A few experimental studies have investigated the feasibility of transcolonic/transrectal endoscopic peritoneoscopy. In
2007, Fong et al. fi rst reported an experimental study on
transcolonic access of the abdominal cavity for peritoneal
exploration [25]. Colonic incision was made with a needle knife in the anterior wall at a distance of 15 –20 cm from the
anus. After endoscopic peritoneal exploration, the incision
site was closed with endoclips, endoloops, or a prototype
closure device. Upper abdominal organs were identifi ed in
all six pigs, and all pigs were alive for two weeks without
complications. To reduce the risk of injury to abdominal
organs and to enable sterile introduction of the endoscope,
Wilhelm et al. developed a sigmoid colonic access method
[26]. First, a fl uid peritoneum was made through a Veress
needle with instillation of a decontamination solution. A
safe access site in the sigmoid colon was verifi ed using an
endolumenal ultrasound probe inserted transanally, and a
guide tube was inserted through the rectosigmoid colonic
entry point into the abdominal cavity. A fl exible endoscope
was inserted via the guide tube into the abdomen, and peritoneal exploration was performed. After the inspection,
closure of the entry site was performed surgically. Transcolonic peritoneoscopy was accomplished without complication in three acute and fi ve survival porcine models. At
necropsy 10 days after the procedure, the colonic incision
sites were well healed, and there were no signs of infection
or peritonitis. Ramamoorthy et al. reported a method for
transrectal endoscopic retroperitoneal access [27]. An
umbilical port was placed for the pneumoperitoneum and
visualization of pelvic access. A rectotomy was made 2 –3 cm
above the dentate line, and a fl exible endoscope was
introduced via the rectotomy into the retrorectal space. The
space was widened by air insuffl ation and a dilation balloon,
and the peritoneal cavity was entered with a needle -knife
under laparoscopic visualization. After peritoneal exploration, the rectotomy was closed surgically under direct vision.
Transrectal peritoneoscopy was successfully performed
without injury to the abdominal and pelvic organs in three
pigs. Although there are several problems related to the
transcolonic approach, including heavy bacterial load, sterility of the colonic lumen, fecal contamination of the abdominal cavity, adjacent organ injury, and tearing of the thin
colonic wall during the procedure, the results of these
studies demonstrated that transcolonic peritoneoscopy based
on safe peritoneal access and the adequacy of the colostomy
closure has signifi cant potential application for peritoneal
exploration.
108
Table 10.2 NOTES peritoneoscopy in humans.
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CHAPTER 10 NOTES for Peritoneal Exploration
Authors Year Access Pure/hybrid
NOTES
Gettman and Blute [30] 2007 Transvesical Hybrid 1 None First report of NOTES peritoneoscopy. Laparoscopy
Kitano et al. [31] 2008 Transgastric Pure 1 None For preoperative cancer staging. Submucosal tunnel
Zorron et al. [32] 2008 Transvaginal Pure 1 None For histologic diagnosis of cancer.
Hazey et al. [33] 2008 Transgastric Hybrid 10 None Pilot study in patients scheduled to undergo operation
Steele et al. [34] 2008 Transgastric Hybrid 3 None Pilot study in patients scheduled to undergo gastric
Hyder et al. [35] 2008 Transgastric Hybrid 1 None Pilot study in a patient scheduled to undergo gastric
Nalura et al. [36] 2009 Transgastric Hybrid 10 None Pilot study in patients scheduled to undergo operation
Nau et al. [37] 2010 Transgastric Hybrid 20 None Pilot study in patients scheduled to undergo operation
Nikfarjam et al. [38] 2010 Transgastric Hybrid 8 1 (Wound
Nau et al. [39] 2011 Transgastric Pure/hybrid 40 None Pilot study in patients scheduled to undergo gastric
Memark et al. [40] 2011 Transgastric Pure 40 1 (Wound
N Complications Comments
was used for assistance.
technique was used.
for pancreatic mass.
bypass for morbid obesity
bypass and cholecystectomy
for pancreatic cancer
for pancreatic mass
Pilot study in patients scheduled to undergo
infection)
infection)
gastrectomy
bypass for morbid obesity
Pilot study in patients scheduled to undergo gastric
bypass for morbid obesity
There are a few reports regarding transvesical peritoneoscopy for peritoneal exploration. Lima et al. assessed the
feasibility of transvesical endoscopic peritoneoscopy in a
porcine model [28]. Under cystoscopic guidance, a vesical
hole was made with an open -ended ureteral catheter. An
overtube was then placed in the transvesical position, and
the ureteroscope was introduced into the peritoneal cavity.
Peritoneal exploration, liver biopsy, and resection of the
falciform ligament were performed using the ureteroscope
in three acute and fi ve survival pigs. After the operation, a
Foley catheter was placed for four days in all survival pigs.
Transvesical peritoneoscopy provided a view of all intra abdominal organs and allowed the surgical procedures to be
performed without complications. Necropsy 15 days after
operation revealed complete healing of the bladder wall exit
site and no signs of infection or adhesions in the peritoneal
cavity. Subsequent experimental study in a human male
cadaver also demonstrated that transvesical peritoneoscopy
with a rigid ureteroscope allowed visualization of the
abdominal cavity with good image quality and manipulation
of the appendix without diffi culties [29]. The results of these
experiments were promising and showed that NOTES peri-
toneoscopy via the transgastric, transcolonic, or transvesical
approach is feasible and safe and provides excellent visualization of the abdominal cavity and the ability to perform
simple surgical procedures with currently available devices.
Human experience
Human clinical experience with NOTES for peritoneal exploration is limited, and there have been no reports of transcolonic peritoneoscopy in clinical practice. Reported human
experience with NOTES peritoneoscopy is summarized in
Table 10.2 [30–40]. The fi rst report of NOTES for peritoneal
exploration was in 2007 when transvesical peritoneoscopy
was successfully performed in a male patient with prostatic
adenocarcinoma [30]. Robotic prostatectomy was planned,
and laparoscopic ports were placed in a standard fashion at
fi rst. Under simultaneous laparoscopic and rigid cystoscopic
guidance, cystectomy was made and a fl exible ureteroscope
was advanced into the abdominal cavity with a guidewire.
Transvesical peritoneoscopy was performed to confi rm
position and plan suprapubic tube placement for reducing
the duration of the indwelling urethral catheter postoperatively. Robotic prostatectomy was then completed, and the
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SECTION 2 Current Clinical Applications and Techniques
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cystectomy site was closed with sutures. No perioperative
complications were observed.
Several previous reports have shown the feasibility of
transgastric endoscopy for peritoneal exploration. In 2008,
our group reported natural orifi ce transgastric peritoneoscopy for pre -operative staging in a pancreatic cancer patient
[31]. The patient was scheduled to undergo staging laparoscopy for pancreatic body cancer. Initially, we made a 3 cm
long narrow submucosal tunnel by ESD technique. The
endoscope was introduced into the abdominal cavity through
the submucosal tunnel, and a Veress needle was then placed
to insuffl ate CO
and monitor for pneumoperitoneum. Peri-
2
toneal exploration was performed without laparoscopic
assistance. The transgastric endoscope provided an excellent
view for cancer staging and could be directed to different
areas of the abdominal cavity with the standard endoscopic
techniques of rotation, torque, and retrofl exion. After confi rmation of operative curability, the patient subsequently
underwent standard open distal pancreatectomy and an
uneventful postoperative course. Zorron et al. reported
clinical diagnostic application of transvaginal endoscopic
peritoneoscopy for cancer staging in a female patient with
suspicion of peritoneal carcinomatosis [32]. A colonoscope
was inserted into the abdominal cavity through a small incision in the vagina, and CO
pneumoperitoneum was estab-
2
lished through the working channel of the endoscope using
a laparoscopic insuffl ator. Peritoneal inspection revealed a
left ovarian tumor and liver and peritoneal metastases. The
lesions were biopsied, and the vaginal wound was closed
surgically under direct vision. Pathological examination confi rmed the diagnosis of ovarian cancer with peritoneal carcinomatosis. The patient recovered well and did not require
postoperative analgesia.
Several pilot studies determined the feasibility and safety
of transgastric endoscopic peritoneoscopy in human beings.
Nau et al. assessed the feasibility and accuracy of diagnostic
transgastric peritoneoscopy in patients who were scheduled
to undergo staging laparoscopy and operation for pancreatic
head mass [37]. In this study, 20 patients successfully underwent diagnostic laparoscopy followed by transgastric peritoneoscopy under laparoscopic guidance. The fi ndings of
transgastric exploration corroborated those of laparoscopic
exploration for surgical decision making in 19 of 20 patients
(95%). Although the time of completion of transgastric peritoneoscopy was longer than that of staging laparoscopy, the
time required for transgastric exploration decreased with
experience. No signifi cant complications related to the transgastric peritoneoscopy occurred, and 14 patients underwent
pancreaticoduodenectomy and 6 underwent palliative gastrojejunostomy. Their group evaluated the safety of transgastric peritoneoscopy to access the peritoneum and perform
adhesiolysis without laparoscopic visualization in patients
undergoing laparoscopic Roux -en-Y gastric bypass for
morbid obesity [39]. For this study, a small gastrotomy was
created at the anterior wall of the stomach with a needle knife, and the gastrotomy was widened with a dilation
balloon. After the transgastric peritoneoscopy, laparoscopic
gastric bypass was completed using the gastrotomy for subsequent gastrojejunostomy creation. The initial 20 patients
underwent transgastric peritoneoscopy with pre -insuffl ation
of the abdomen, and the peritoneal cavity was successfully
accessed in the second 20 patients without pre -insuffl ation.
During transgastric peritoneoscopy, six occult umbilical
hernias, one inguinal hernia, and one hiatal hernia were
noted. Intra -abdominal adhesions were observed in twenty
patients, and endoscopic adhesiolysis was performed in fi ve
patients. Although there were no major complications associated with transgastric peritoneoscopy, nine small burn
wounds were made in the process of transgastric peritoneal
access, including four burns on the abdominal wall and fi ve
on the left lobe of the liver. This group also investigated the
risk of infectious complications related to transgastric endoscopic peritoneoscopy [40]. Their study included 40 patients
scheduled for laparoscopic gastric bypass. Patients received
pre-operative intravenous antibiotics and no gastric decontamination. Saline aspiration samples were obtained from
the gastric lumen prior to the gastrotomy and from
the peritoneal cavity after transgastric access. The median
numbers of colony -forming units (CFU) from the gastric and
peritoneal samples were 980 and 323 CFU/ml, respectively.
Although cross -contamination of the peritoneal cavity with
species isolated from the stomach was documented in eight
patients, there were no infectious complications. One port site infection occurred, but there were no intra -abdominal
infections. Sub -analysis of 15 patients receiving proton
pump inhibitors (PPIs) was performed. The bacterial counts
of the gastric and peritoneal samples from patients receiving
PPIs were greater than those from patients not receiving
PPIs, but the subgroup on PPIs did not experience an increase
in infectious complications.
There are two pilot studies to assess the ability of transgastric endoscopy to approach and visualize the abdominal
organs. Steele et al. evaluated the potential feasibility of
transgastric peritoneoscopy in assessing different regions
inside the abdomen in three patients undergoing laparoscopic gastric bypass [34]. Systematic evaluation of the liver,
the epigastric area, and the small intestine was achieved
through the transgastric endoscope, without laparoscopic
assistance. It was diffi cult to navigate the transgastric endoscope to the right lateral and superior segments of the liver.
Nikfarjam et al. examined the effi cacy of various methods
of anterior gastric access for diagnostic transgastric peritoneoscopy in patients undergoing planned laparoscopic gastrectomy [38]. After performing laparoscopic abdominal
exploration in a standard fashion, transgastric abdominal
access was independently established by a Seldinger technique. Visualization of all four abdominal quadrants was
attempted with the transgastric endoscope. A total of nine
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procedures were performed in eight patients. The gastrectomy site was the body in three patients, the lesser curvature
in three, the greater curvature in one, the fundus in one,
and the antrum in one. The transgastric endoscope provided
satisfactory navigation to the right upper and both lower
quadrants. Navigation to the left upper quadrant, specifi cally
to the spleen, was diffi cult and could be successfully achieved
in only one patient, in whom the gastrotomy site was at the
greater curvature. There were no major complications.
Surgical technique
Transgastric peritoneoscopy with the submucosal
tunnel technique
The submucosal tunnel technique using the ESD method
appears to be the most reliable technique for safe transgastric
peritoneal access and secure gastric closure with current
commercially available devices [41]. This technique appears
to have several advantages: (i) the procedure can be accomplished with commercially available equipment; (ii) the
offset mucosal entry site is distant from the seromuscular
exit site, and the submucosal tunnel can minimize intraperitoneal leakage of gastric contents during the operation; (iii)
it can provide scope stabilization; (iv) after withdrawal of
the endoscope into the stomach, gastric distention can be
maintained without obvious pneumoperitoneum, and it
allows satisfactory gastric closure with a better endoscopic
view and working space; (v) the two approximated surfaces
of the longitudinal narrow tunnel bond immediately and
promote wound healing; and (vi) the ESD technique is
useful for safe creation of an adequately sized submucosal
tunnel [21–23,31,42–44]. This chapter outlines our technique of transgastric peritoneoscopy with a submucosal
tunnel technique for preoperative pancreatic cancer staging
(Video 10.1).
Under general anesthesia, the patient is placed in the left
lateral decubitus position. Antibiotics are intravenously
administered at the start of the procedure. The abdomen and
the oral fi eld are prepared and draped in a sterile manner.
A single -channel fl exible upper gastrointestinal endoscope
with a transparent hood is used. The endoscope and all
accessories are subjected to high -level disinfection and gas
sterilization. CO
insuffl ation with an endoscopic CO 2 regu-
2
lation unit is used to prevent bowel dilatation and pneumoperitoneum during the procedure.
First, a 5 cm long narrow submucosal tunnel is created in
the anterior wall of the stomach by the ESD technique. The
site for creation of the submucosal tunnel is selected using
the imprint of the operator ’s fi nger pressure on the abdominal wall to prevent injury to adjacent organs. After injection
of normal saline solution into the submucosal layer (Figure
10.1), an initial small incision is made in the submucosal
cushion with a Flex knife (KD -630L; Olympus Medical
Systems Co., Tokyo, Japan) (Figure 10.2). This incision
allows an insertion of an insulation -tipped (IT) knife
Figure 10.1 Normal saline solution is injected into the submucosal layer
of the stomach.
Figure 10.2 A small incision of the mucosa is made in the submucosal
cushion.
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SECTION 2 Current Clinical Applications and Techniques
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(a)
Figure 10.3 The mucosal incision is extended to a length of 2 cm with
an insulation -tipped knife.
Figure 10.5 Additional normal saline is injected into the submucosal
layer.
(KD-610L; Olympus), and the mucosal incision is extended
to a length of 2 cm (Figure 10.3). Submucosal dissection is
then carried out carefully with the IT knife to create a longitudinal submucosal tunnel (Figures 10.4–10.6). A small
incision in the seromuscular layer is made in the distal end
(b)
Figure 10.4 Dissection of the submucosal layer is performed with
lateral movement of the insulation -tipped knife.
of the submucosal tract with the Flex knife (Figure 10.7),
and the incision is enlarged with a 15 mm endoscopic dilation balloon (CRE5842; Boston Scientifi c, Natick, MA, USA)
(Figure 10.8). The endoscope is then advanced into the
peritoneal cavity, and peritoneal exploration is performed
with standard endoscopic techniques such as advancement,
withdrawal, torque, and retrofl exion of the endoscopic
shaft, as well as movement of the endoscopic tip. The transgastric endoscope provides an excellent view of the abdomen
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Figure 10.6 Creation of an approximately 5 cm submucosal tunnel is
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completed.
CHAPTER 10 NOTES for Peritoneal Exploration
Figure 10.7 A small incision is made at the seromuscular layer in the
distal end of the submucosal tunnel.
Figure 10.8 An endoscopic dilation balloon is inserted into the small
incision, and the opening is enlarged.
and approaches to different areas (Figures 10.9–10.12).
When endoscopic visualization is limited due to intra abdominal adhesions (Figure 10.13), endoscopic adhesiolysis is performed with the IT knife (Figure 10.14). Here, a
suspected metastatic lesion is biopsied using endoscopic
Figure 10.9 View of the transgastric peritoneoscopy: retrofl ex
panoramic view of the peritoneal cavity showing omentum.
biopsy forceps (Figure 10.15), and intraoperative frozen
section examination is performed. After confi rmation of
operative curability, the endoscope is withdrawn back into
the stomach (Figure 10.16), and the mucosal entry point in
the stomach is closed with endoclips (Figures 10.17, 10.18).
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