Introduction
Natural orifice transluminal endoscopic surgery (NOTES) is an emerging technique for
accessing the peritoneum without parietal incisions in an effort to potentially reduce
procedure-related morbidity and mortality [1]
[2]. Although the outcome of laparoscopic gastrojejunal anastomosis (GJA) appears to
be improving, it is still associated with surgical and anesthetic adverse events,
including anastomotic insufficiency, ventral hernia, and wound infections [3]
[4]
[5]
[6]
[7]
[8]
[9]
[10]. NOTES may present a less invasive alternative for GJA for various indications,
including benign or malignant gastroduodenal outlet obstruction and bariatric procedures.
Only a few studies have assessed the feasibility of performing this procedure exclusively
by NOTES with, to date, 42 GJA procedures reported in the literature in the porcine
survival animal model. These reports are associated with some limitations, including
small sample sizes, lack of reproducibility, and absence of histological assessment.
Moreover, virtually all survival studies using animal models were performed as laparoscopically
assisted (“hybrid”) NOTES procedures [11]
[12]
[13]
[14]
[15]
[16]
[17]
[18]. The creation of a pure NOTES bariatric gastric bypass appears to be technically
difficult in human cadavers [19]
[20].
Several endoscopic tissue approximation systems have been proposed for the closure
of the gastrostomy after NOTES, including T-tags, Padlock-G clip (Aponos Inc.), and
the “over-the-scope” system (OVESCO) [21]
[22]
[23]
[24]
[25].
The aim of this study was to evaluate the feasibility, safety, and efficacy of a pure
NOTES gastrojejunal bypass procedure in a 3-week survival porcine model. Feasibility
and efficacy were assessed using technical parameters such as procedure time, technical
difficulty, and the occurrence of intraoperative adverse events. Safety was assessed
by monitoring the animals postoperatively for any clinical signs of intra-abdominal
infection and sepsis. Anastomotic integrity and patency were evaluated grossly during
necropsy as well as histologically. The clinical outcome was evaluated by monitoring
dietary intake and by weight curve assessment.
Materials and methods
Study design
This was a prospective experimental survival animal study conducted at the Center
for Surgical Education and Research (CERC) of the Faculty of Medicine North, Mediterranean
Aix-Marseille University. Institutional review board approval was obtained prior to
conducting the study.
The experimental protocol consisted of performing a purely endoscopic procedure with
general anesthesia on nine consecutive healthy young domestic Yorkshire “minipigs”
of either sex, aged 3 – 4 months and weighing between 25 and 30 kg. All animals were
allowed to recover and were then clinically observed under normal feeding and housing
conditions. Euthanasia and necropsy were performed following a 3-week survival period.
Animal preparation, anesthetic and analgesic protocols
All animals were fasted for 24 hours prior to intervention. Anesthesia was induced
by an intramuscular injection of 120 mg of azaperone (Stresnil) coupled with 70 mg
of ketamine, followed by endotracheal intubation. Anesthesia was maintained by continuous
intravenous infusion of propofol at a rate of 100 mg per hour (Diprivan 2 %), and
fentanyl was given at a dose of 100 micrograms per hour for analgesia, with monitoring
of heart rate and oxygen saturation via pulse oximetry. The animals also received
1 g of cefotaxime as antimicrobial prophylaxis preoperatively as well as intraoperatively.
All animals were placed in a supine position for the procedure.
Following recovery from anesthesia, pain was assessed twice a day by observing animal
behavior, and 1 g of cefotaxime was administered intramuscularly daily for a period
of 7 days.
Endoscopic equipment and intervention stages
All procedures were carried out using a double-channel video esophagogastroduodenoscopy
endoscope (3.8 – and 2.8-mm channel diameters; Karl Storz GmbH & Co. KG, Tuttlingen,
Germany). The electrosurgical unit used was the Olympus ESG-100 (Olympus Corporation,
Tokyo, Japan). Three interventional endoscopists performed all the procedures.
The NOTES GJA was performed using a standardized method. All the stomachs were decontaminated
before each intervention. To access the peritoneum, a longitudinal, plane-by-plane
gastric incision of 3 – 5 cm was made using the needle-knife (Olympus Europe Corporation)
at the anterior wall of the stomach in the pre-antral region ([Fig. 1]). A pneumoperitoneum was created using room air insufflation. A jejunal loop was
selected and grasped on its border with a twin-grasping forceps (Twin Grasper; OVESCO
AG, Tuebingen, Germany). The optimal loop was selected after peritoneal examination,
based only on its proximity to the access site to avoid further tension on the anastomosis.
The selected loop was mobilized ([Fig. 2]) toward the gastric incision site with careful attention to avoiding tension on
the loop that might possibly result in anastomotic dehiscence or bowel ischemia postoperatively.
Fig. 1 Longitudinal, plane-by-plane gastric incision using the needle-knife at the anterior
wall of the stomach in the pre-antral region.
Fig. 2 Selection, grasping and mobilization of an appropriate jejunal loop toward the gastric
incision with a Twin-Grasper forceps.
To create the stoma, the mesentery under the raised loop was punctured and the rigid
end of a 0035'' guidewire (Jagwire Stiff; Boston Scientific Corporation, Natick, USA)
was advanced within a sphincterotome (Tritome; Cook Medical, Limerick, Ireland) and
through the mesentery ([Fig. 3]). The sphincterotome was then exchanged for placement of a fully covered self-expandable
metallic (SEMS) biliary stent (10 cm long, CLBS; Cook Medical, Limerick, Ireland)
with its free ends being within the mesentery on both sides of the loop ([Fig. 4]). This provided the same function as a loop ileostomy rod, preventing the intestinal
loop from falling into the peritoneal cavity when the stoma was created. The jejunum
was opened with a longitudinal 2-cm incision at the antimesenteric border, using a
Dual Knife, and then extended with a Hook Knife (Olympus Corporation).
Fig. 3 Puncture of the mesentery under the raised loop with the rigid end of a 0035'' guidewire
, which was then advanced within a sphincterotome and through the mesentery.
Fig. 4 Placement of a fully-covered biliary self-expandable metallic stents(SEMS) (10 cm
length), with its free ends being within the mesentery on both sides of the loop.
Full-thickness suturing of the jejunal loop into the gastric stoma was accomplished
using a Brace Bar prototype suturing system ([Fig. 5]) (Brace Bar; Olympus, Japan). This device consists of a needle with suture thread
within the sheath and two T-tags, one on each end of the thread. For creating the
anastomosis, two sutures were dropped successively through the jejunal and gastric
walls. The two suture sides were then secured with a crimping device that tightens
the two stitches against one another. A complete anastomosis was achieved using four
to seven stitches equally distributed along the anastomotic perimeter ([Fig. 6]). The biliary SEMS was removed using the Twin Grasper followed by placement of two
extra T-tag sutures to close the gaps left by the stent. The anastomotic integrity
was finally carefully inspected, visually and using the grasper, to detect any gaps
between sutures. We could not fill the stomach with contrast because fluoroscopy was
not available.
Fig. 5 The Brace Bar suturing system. Needle, handle, and T-tag recharge.
Fig. 6 Achievement of the complete anastomosis using four to seven stitches equally distributed
along the anastomotic perimeter.
To simulate a gastric outlet obstruction, two T-tags were placed at the level of the
pylorus in an “X” fashion. Following a final inspection, the stomach was decompressed
and the endoscope withdrawn. In the case of bleeding, coagulation was attempted using
a coagulation forceps (Coagrasper, Olympus Corporation, Japan) set at 60 W in the
soft-coagulation mode (Olympus ESG-100 (Olympus Corporation, Tokyo, Japan). In the
case of signs of tension pneumoperitoneum, decompression of insufflation was accomplished
using a percutaneously placed 20G needle.
Follow-up and postoperative protocol
All animals were clinically observed for a period of 3 weeks. After recovery from
anesthesia, animals were kept fasted with access to water until the third postoperative
day (POD). Institution of nutrition was performed gradually: a quarter of the usual
feeding was given for 48 hours with progression to half portions for 48 hours before
normal feeding from POD 3 until POD 21. Clinical follow-up was performed daily, with
twice-daily monitoring of overall behavior, food intake, fever, pain, and bowel and
urinary function. The animals’ weights were measured at baseline and at the end of
the 3-week study period.
The weight curve of a control group of the same number of animals with the same characteristics
(3 – 4 months old) was also followed for 3 weeks. These animals were enrolled in a
study associated with bladder pressure measurement. It was considered that the urological
procedure would not have any effect on the physiologic growth of this control group.
Euthanasia and histological assessment
Euthanasia was performed after 21 survival days by lethal injection of potassium chloride
with animals under general anesthesia. In the case of death during the 3-week period,
necropsies were performed to determine whether signs of anastomotic leakage or peritonitis
were present. Before euthanasia, the peritoneal cavity was inspected after laparotomy
for signs of peritonitis, and all organs were macroscopically examined for signs of
infection, scar formation, and necrosis. Anastomotic patency was assessed by catheterizing
the afferent and efferent loops with surgical clamps and a finger respectively. Then
the entire anastomosis was removed for histopathological examination, and the diameter
of the stoma on the gastric side was directly measured to confirm patency.
The anastomotic healing pattern was assessed by histological analysis showing a fusion
of the small-intestinal mucosal and muscular layer against the gastric mucosa and
muscular layer, respectively. To assess its integrity, the anastomotic site was also
histologically observed for the presence of scar formation, necrosis, inflammation,
and fistula.
Statistical analysis
Descriptive, statistical analysis of normally distributed variables is expressed as
means with standard deviations (SDs) and ranges. Qualitative variables are expressed
as percentages. The small size of the study did not allow for comparative tests in
univariate analysis by Fisher's exact test or the use of a chi-squared distribution
to search for predictive factors of death. Unpaired Student's t tests were used to determine the significance of differences between means. A P value < 0.05 was considered statistically significant. Statistical analysis was performed
using the SAS software (Enterprise Guide 4.1 for Windows, SAS Institute Inc., Cary,
NC, USA).
Results
The data related to technical and clinical outcome from NOTES gastrojejunal anastomosis
are summarized in [Table 1].
Table 1
Summary of technical and clinical outcomes from natural orifice transluminal endoscopic
surgery (NOTES) gastrojejunal bypass in nine pigs
|
Animal no.
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
|
Anesthesia
|
|
|
|
|
|
|
|
|
|
|
Oxygen rate < 90 %
|
No
|
No
|
No
|
No
|
No
|
No
|
No
|
No
|
No
|
|
Tachycardia > 120 /min
|
Yes
|
No
|
No
|
No
|
No
|
No
|
No
|
No
|
No
|
|
Endoscopic procedure
|
|
|
|
|
|
|
|
|
|
|
Total time, minutes
|
142
|
145
|
110
|
115
|
115
|
95
|
80
|
105
|
65
|
|
Anastomosis suture time, minutes
|
40
|
65
|
30
|
40
|
30
|
50
|
30
|
30
|
30
|
|
Number of stitches, n
|
4 + 1
|
7 + 1
|
5 + 1
|
6 + 2
|
5 + 1
|
7 + 2
|
6 + 1
|
6 + 1
|
4 + 2
|
|
Follow-up
|
|
|
|
|
|
|
|
|
|
|
Transit
|
Yes
|
Yes (D5)
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
Yes
|
No
|
|
Stool consistency
|
Normal
|
Diarrhea
|
Diarrhea
|
Diarrhea
|
Normal
|
Normal
|
Normal
|
Normal
|
NO
|
|
Weight before procedure, kg
|
28
|
30
|
30
|
31
|
35
|
25
|
29
|
30
|
28
|
|
Weight after procedure, kg
|
28
|
29
|
22
|
N
|
32
|
N
|
27
|
N
|
N
|
|
Occlusion
|
No
|
No
|
No
|
No
|
No
|
No
|
No
|
No
|
No
|
|
Sepsis, postoperative day (POD)
|
No
|
No
|
No
|
Yes
(POD 12)
|
No
|
Yes
(POD 9)
|
No
|
Yes
(POD 5)
|
Yes
(POD 5)
|
|
Death (POD)
|
No
|
No
|
No
|
Yes
(POD 13)
|
No
|
Yes
(POD 9)
|
No
|
Yes
(POD5)
|
Yes
(POD 5)
|
|
Autopsy
|
|
|
|
|
|
|
|
|
|
|
Peritonitis signs
|
No
|
No
|
No
|
No data
|
No
|
Yes
|
No
|
Yes
|
Yes
|
|
Adhesions
|
No
|
Some
|
No
|
" "
|
No
|
Yes
|
No
|
No
|
Yes
|
|
Anastomotic leakage
|
No
|
No
|
No
|
" "
|
No
|
Yes
|
No
|
Yes
|
Yes
|
|
Local inflammation
|
No
|
No
|
No
|
"
|
No
|
Yes
|
No
|
Yes
|
Yes
|
Endoscopic procedure
A gastrojejunal anastomosis with a pure NOTES approach was successfully performed
in nine animals with an excellent reproducibility. The mean (± SD) operative time
was 108 ± 26 minutes (range 65 – 142) and most procedures (7/9) lasted less than 120
minutes. The average duration of each step of the procedure was as follows ([Fig. 7]): (i) gastric incision, 9.1 ± 5.4 minutes (4 – 20); (ii) transgastric peritoneal
cavity access and jejunal loop selection and transfer, 9.7 ± 6.3 minutes (5 – 25);
(iii) Biliary SEMS placement for bridging, 22 ± 17 minutes (5 – 55); (iv) jejunal
loop incision, 8 ± 3.5 minutes (5 – 15); (v) anastomotic suture, 38.3 ± 12.2 minutes
(30 – 65).
Fig. 7 Time required (minutes) for completion of each technical step of the gastrojejunal
anastomosis procedure (9 animals).
Four to seven sutures were required for the completion of the GJA (mean 5.55 ± 1.30).
Two additional stitches were required for closing the residual gap between the approximated
tissue following removal of the biliary SEMS. The pyloric closure procedure required
one or two T-tag sutures.
Intraoperative adverse events
For the duration of anesthesia, none of the animals developed hypoxemia (Sao
2 < 90 %). Regarding hemodynamic stability, one animal developed an episode of supraventricular
tachycardia (> 120 /min) that resolved within minutes without intervention. Needle
decompression of the pneumoperitoneum was not required in any of the animals.
There were no intraoperative adverse events such as bleeding, perforation or organ
damage. At necropsy, we did not find any evidence of bleeding or clot formation.
Postoperative outcome and follow-up
Clinical course
In total, five animals had a favorable postoperative course without sequelae. The
animals resumed feeding and three animals developed diarrhea. Four animals died due
to anastomotic leakage, which was confirmed by the presence of clinical sepsis associated
with anastomotic dehiscence and peritonitis confirmed at necropsy. Two of these animals
died before POD 5 and the other two before POD 13. The deceased pigs had 5, 7, 9,
and 6 stitches in their anastomosis and the average endoscopic duration time was 95
minutes versus 118 minutes for the rest of the animals (not significant [n.s.]). Upon
endoscopic inspection, all four animals with anastomotic leaks postoperatively appeared
to have shown a satisfactory anastomotic pattern intraoperatively.
Postoperative weight curve
The weight curve in the five animals that survived in our study was compared with
that of the control group. The baseline weight of the current study group was 29.5 kg
whereas it was 29.7 kg in the control group (n.s.) and all the survival pigs were
in perfect clinical condition without signs of sepsis and had a normal refeeding process.
It was also assumed that the average weight gain of a 4-month-old pig is ~1 kg per
week.
In our series, we observed an average weight loss of 3.2 ± 3.1 kg (range 0 – 8 kg),
whereas in the control group, we noted an average weight gain of 5.2 ± 1.6 kg [3 – 7 kg].
This difference was statistically significant (P < 0.0005) demonstrating the effectiveness of the intervention with regard to accomplishing
weight loss.
Necropsy findings
At necropsy, none of the animals that had survived over the 3-week postoperative period
showed any signs of peritonitis, but some adhesions were observed in one animal. All
anastomoses were macroscopically healed with easy identification of both the afferent
and efferent loops. Additionally, the gastric opening’s macroscopic diameter was measured
at ~2 cm so we could easily separately catheterize the two loops during digital examination
([Fig. 8]), whereas this was impossible in the dehiscence group because of a complete leakage.
Fig. 8 Macroscopic examination of the gastrojejunal anastomosis during necropsy at 3 weeks
post-surgery. Catheterization of each loop with surgical clamps.
Histological analysis
In all the survival animals the GJA sites were available for histological examination.
The anastomotic opening at the level of the gastric mucosa had a mean diameter of
20 ± 4.2 mm. At the level of the anastomotic gastroenteric junction, we observed a
complete fusion of mucosal and muscular layers with mild to moderately acute and chronic
inflammatory changes. These included highly polymorphic granulomatous tissue with
infiltration of lymphocytes, rare plasma cells, macrophages, and neutrophils. The
submucosa was infiltrated with collagen, fibroblasts and new blood vessels. A foreign-body
reaction at the level of the suture was observed in some of the animals ([Fig. 9]).
Fig. 9 Histological assessment of the gastrojejunal anastomosis at 3 weeks post-surgery.
1 Apparent scar formation is seen at the level of the mucosa (GM, JM) and beginning
of the collagenization of the entire gut wall with presence of discrete inflammatory
infiltrate (HES, × 1 magnification). 2 Continuity of muscular mucosa layer is seen at the level of the gut wall presenting
with highly polymorphic granulomatous tissue (HES, × 1 10magnification).
Discussion
This experimental study confirms the feasibility of performing a GJA using an exclusively
NOTES approach with avoidance of laparoscopic assistance. Potential advantages of
a pure NOTES gastric bypass without laparoscopic assistance relate to the avoidance
of skin incisions with a decreased risk of ventral hernia and wound infections. The
first population of patients that may benefit from NOTES gastrojejunostomy are moribund
patients with gastric outlet obstruction. Frequently, because of advanced age or significant
co-morbidities, including coronary artery disease or chronic heart failure, these
patients may not be candidates for general anesthesia. Because of the less invasive
character of NOTES, with the potential for performing NOTES GJA with monitored anesthesia
care, endoscopic treatment might be appropriate in these patients by avoiding the
general anesthesia that laparoscopy would require. The possibility of performing NOTES
under monitored anesthesia care has been demonstrated recently [26]
[27]. However, NOTES GJA may prove to be of benefit also in bariatric surgery. Especially
obese patients are more prone to wound infection because the decreased perfusion of
fat tissue makes this population more prone to infections. Frequently, obese patients
have type II diabetes mellitus, which further increases the risk of wound infection.
Often, laparoscopic access proves difficult in severely obese patients because of
the increased abdominal wall thickness. It is not uncommon that in patients undergoing
laparoscopic Roux-en-Y gastric bypass, a conversion to laparotomy is required. Because
of the increased intra-abdominal pressure in obese patients, this population is significantly
more prone to ventral hernias. We would agree that for now this endoscopic technique
of GJA seems more suitable for the treatment of gastric outlet obstruction in a palliative
setting. However, in this study, we did not plan a gastric volume-reducing procedure
as in sleeve gastrectomies but we did achieve a digestive bypass by associating a
GJA and a pyloris closure.
We created a pyloric closure to mimic the conditions seen in benign or malignant gastric
outlet obstruction and to create a restrictive component as seen in bariatric bypass
procedures. The interventions were performed without any intraoperative adverse events,
but we observed postoperative anastomotic dehiscence leading to abdominal infection
and sepsis in 44 % (4 /9) of the animals. We think that a clinical success rate of
56 % shows that the technique is still a long way from human application, but that
with further refinement of the suturing technique the success rate may reach acceptable
values. We believe that further technical development is required to improve the T-tag
suturing technique to achieve an improved and acceptable survival rate.
The NOTES GJA procedure was also highly reproducible, with little change required.
We decided to perform the procedures under air insufflation because CO2 insufflation in animal models for NOTES has not been proved to be better than air
insufflation. Effectively, we believe that CO2 would not have made any change on the outcomes. All the stomachs were obviously cleaned
prior incision of the gastric wall, as recommended in the literature. In the surviving
pigs at the end of the follow-up we did not find any peritonitis. We verified that
the incision technique with a simple needle-knife was safe and efficient with results
comparable to those of the techniques similar to percutaneous gastrostomy (PEG) described
earlier [28]. Spatial orientation in the peritoneum and selection of the jejunal loop were among
the most difficult steps in this procedure. Alternative methods have been described
for jejunal loop selection but in our opinion they are relatively cumbersome. Kantsevoy
et al. describe a tracking method using insertion of an optic fiber into the jejunum
via a colonoscope. This procedure requires specialized equipment and further logistical
support [29]. Another option could be the use of fluoroscopy for detection of the proximal jejunal
loop by contrast injection in the duodenum. Thus, we agree that making a reliable
loop selection was a limit in our technique, although this initial step is very important
in the standardization of the GJA procedure. In this study, we tried only to select
a loop in the middle of the accessible bowel and we are currently working on a study
aimed at reliable determination of the length of the selected loop. Another challenge
was stabilizing the jejunal loop within the gastrostomy site. In the literature, many
techniques for addressing this challenge have been reported, often describing a “hybrid”
technique coupled with laparoscopy. Chiu et al. [15] demonstrated a simple grasping technique using forceps prior to suturing with a
surgical stapler via both percutaneous and transgastric access. Bergström et al. [11] and Kantsevoy et al. [12] proposed an exposure with a polypectomy loop. The latter group first sutured the
jejunal loop to the gastric wall before opening it. The use of a PEG technique has
also been demonstrated but this appeared to complicate the procedure and lengthen
the examination time [17]. An alternative technique of endoscopic gastroenteric anastomosis using a magnet
inserted into the distal duodenum has been recently proposed, with reported efficacy
[30]. However, this technique requires several endoscopies and has complication rates
that are currently not acceptable. In the present study, we decided to expose the
jejunal loop using a “bridge support” technique by inserting a metal stent. This technique
is comparable to the creation of a surgical ileostomy using a bridging rod across
the mesentery [31]. The suture remains the major challenge in all studies proposing the creation of
an anastomosis. We made the GJA using the innovative Brace Bar prototype system, which
uses the principle of “sewing” with T-tags using a single needle. This device provided
a classic full-thickness suture, with approximation of gastric mucosa to jejunal serosa
as confirmed by histological analysis. The limitation of this technique was the prolonged
procedure length resulting from the time required to reload the T-tags into the needle
after each stitch. Most importantly, we observed incomplete anastomosis as described
above.
The clinical follow-up permitted confirmation of the integrity, functionality, and
effectiveness of the gastric bypass in the five surviving animals, including the two
animals that had a partial gastric closure (pigs #1 and #2). Transit was modified
in three of these animals, suggesting a functional anastomosis. In all these animals,
the GJA was perfectly healed at laparoscopic examination, without peritonitis or leakage
signs. Most important, for the first time in a GJA animal study we measured and compared
the weight curve of the intervention group with that of a control group. We noted
an average weight loss of about3 kg with a normal feeding pattern, whereas the control
group showed an average weight gain of 5 kg within the 3-week study period. Pyloric
closure was surely one of the explanations for such a weight difference. The size
of the gastrojejunal orifice ranged between 12 to 25 mm suggesting good functionality.
We think that the use of the metallic stent helped to accomplish this adequate opening
size. The stent allowed better exposure, enabling a larger gastric incision and wider
stitch placement around the jejunal loop. Using a hybrid technique with a stapler,
Chiu et al. [15] achieved an average orifice size of 30 mm in 11 animals undergoing gastrojejunostomy,
but the group did not assess weight gain or loss postoperatively.
Histological analysis revealed scarring often accompanied by local acute and chronic
inflammatory infiltrates at the anastomotic site. Additionally, we also observed an
increase in the collagen matrix of junctional zones, especially in the submucosa,
and the restoration of the continuity between the mucosal muscle layers. The restoration
of the muscular layer occurred more irregularly. In one study, anastomotic healing
after a NOTES gastrostomy procedure [32] on 12 pigs showed similar results at 2 weeks post-surgery. Corroborating the findings
of other studies [5]
[33], survival at 3 weeks post-surgery in the present study was primarily related to
the strength of the anastomosis.
In conclusion, the results of our study demonstrate the feasibility and efficacy of
performing gastrojejunal bypass using an exclusively endoscopic transgastric approach.
However, the safety of the procedure was not satisfactory: the high mortality encountered
remains a problem of great concern especially as the mortality resulted exclusively
from anastomotic leaks. Because of the limited number of animals in this study, we
could not establish predictive factors for death from anastomotic leakage. However,
some factors known to promote anastomotic adverse events such as anastomotic tension
and trauma induced during the procedure are probably not yet fully controlled [30]
[34]. Moreover, in the present study we speculated that leakage was due to the pressure
exerted on the healing anastomosis after the pylorus had been closed; such a pressure
was higher than the sutures could withstand. We think that in effect the anastomosis
may require sufficient time for healing and consolidation before the gastric outlet
obstruction is instituted. Based on this assumption, we propose that a subsequent
study should investigate the bypass procedure in two steps, with performance of a
GJA first and then later the pyloric closure. Obviously, in patients, all the procedures
should be performed with CO2 insufflation to improve the outcomes in terms of tolerance of the pneumoperitoneum
and abdominal pain, in the absence of contraindication. Further refinement of the
suturing technique or modifications of the creation of the anastomosis (by using stents)
may help to improve the morbidity and mortality associated with this approach, in
addition to using the two-steps approach. Finally, we need to compare our technique
with the laparoscopic technique, which is the gold standard, and to evaluate the consequences
on metabolic markers following such a NOTES approach.
