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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_5554_Библиотеки_им_академика_М_И_Перельмана.pdf
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1
Lower Third of the
Esophagus
1st stapling - esophageal
view
After 2nd stapling,
endoscopic left
after 2nd stapling
after 2nd stapling (2 arrows)
-
esophageal view
Lower Third of the
Esophagus
after 3rd stapling-
esophageal view
Gastric Cardia
after 3rd stapling-
pre-stapling. Hill Grade III
noted from lesser curve.
Lower Third of the
Esophagus
1st plication
23
4
5
67
8
9
10 11
12
Fig. 2.5 Anatomical landmarks during MUSE surgery
Fig. 2.4 MUSE ow diagram
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2.2.3.4 Comparisons ofClinical Application andEfcacy
MUSE is widely used for the treatment of GERD, and its safety and efcacy
have been veried in several clinical trials [1, 18, 19, 21]. A preclinical animal
experiment showed that 12 experimental animals who underwent partial fundo-
plication had operation-related complications. In a multicenter, prospective
cohort study, Zacherl etal. evaluated the efcacy of MUSE in 69 patients with
gastroesophageal reux. At 6months after the operation, HRQL improved sig-
nicantly in 73% of patients (>50%), and PPI was stopped in 64.6% of patients.
Besides, two patients had adverse events of empyema and gastrointestinal bleed-
ing at the beginning of the study. Kim etal. conducted a 4-year multicenter
clinical study on 37 patients who had undergone MUSE fundoplication, during
which there were no related complications, and the HRQL score was signi-
cantly decreased. The follow-up showed that the proportion of patients still tak-
ing PPI for 6months and 4years decreased to 83.8% and 69.4%, respectively,
and the dosage of drug treatment also decreased from 66.1Mg (baseline) to
10.8Mg (6months after operation) and 12.8Mg (4years after operation) from
66.1Mg (baseline). Roy Shapira [18], in a multicenter prospective study with a
5-year follow-up, found that 13 patients underwent postoperative HRQL symp-
tom assessment and PPI dose monitoring. The results showed that 92% of the
patients who had GERD-related symptoms returned to normal, 77% of the
patients stopped PPI, or the dose was reduced by half, and 54% of the patients
completely stopped using drugs. Zacherl etal. conducted a multicenter study of
66 patients. The results showed that the GERD-HLRP score of 73% of the
patients improved signicantly, about 65% of the patients stopped PPI com-
pletely, and more than half of the remaining 35% patients signicantly reduced
PPI dosage. However, two patients had serious adverse reactions, namely,
empyema and gastrointestinal bleeding. Due to the late clinical use of the device,
there is no relevant data on long- term efcacy and safety.
2.2.4 Follow-Up andEfcacy Evaluation
GERD-HRQL questionnaire was conducted when the patient stopped PPI treat-
ment for at least 7days, including 6 items related to heartburn and problems
related to other GERD symptoms, drug use, and satisfaction with the current
situation. The higher the GERD-HRQL (total score between 0 and 50) was, the
more severe the symptoms were. The follow-up time was 0 week, 1 week,
4weeks, 12weeks, 6months, and other random time, and adverse events were
evaluated. Serious adverse events included death, life-threatening or prolonged
hospital stay (72 h of hospitalization after surgery were allowed, and the
length of stay longer than 72h was recorded as serious adverse events) [18, 21]
(Tables 2.1 and 2.2).
2 Endoscopic Fundoplication forGastroesophageal Reux Disease
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Table 2.1
Symptom response within 6years after TIF treatment with EsophyX
®
device
Study 6M 12M 24M 36M 6Y
Cadière etal. (2008) – 85% – – –
Cadière etal. (2009) – – 93% – –
Testoni etal. (2010) 82% 76% – – –
Velanovich etal. (2010) 79% – – – –
Repici etal. (2010) 55% 47% – – –
Demyttenaere etal. (2010) – 53% – – –
Hoppo etal. (2010) – 42% – – –
Barnes etal. (2011) 93% – – – –
Bell etal. (2011) 75% – – – –
Ihde etal. (2011) 76% – – – –
Trad etal. (2012) – 82% – – –
Testoni etal. (2012) – – 75% 75% –
Petersen etal. (2012) 58% – – – –
Bell etal. (2012) 86% – – – –
Muls etal. (2013) – 77% – 65% –
Bell etal. (2013) – 82% – – –
Bell etal. (2014) – – 77%–80% – –
Trad etal. (2015) 93% – – – –
Hunter etal. (2015) – 72% – – –
Testoni etal. (2015) 84% 80% 88% 84% 86%
Table 2.2
Symptom response within 6years after TIF treatment in MUSE™ system
Study 6M 12M 24M 36M 6Y
Zacheri etal. (2015) 83% – – – –
Roy-Shapira etal. (2015) – 82% 73% 73% –
To date, 21 prospective studies (3 randomized, controlled) and 1 retrospective
study have been published to use EsophyX.Most studies were observational, con-
ducted in a limited series, followed up for 1–3years. GERD-HRQL problem was
used to evaluate symptoms in 16 studies, and pH±impedance was monitored in 11
studies before and after surgery. The results showed that 75%–93% and 72%–85%
of patients stopped PPI or reduced the dose by half after TIF, and 37%–89% of
patients normalized esophageal acid exposure; 24months after TIF, the daily high-
dose PPI dependent elimination rate was 75%–93%. In the only study that was fol-
lowed up for 6years after TIF (14 out of 50 patients), 86% of patients eliminated
high-dose PPI dependence, and about half of the patients stopped PPI completely.
The results at 6years were like those at 36months, which provided evidence for TIF
persistence.
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Only two studies have reported the results of TIF with MUSE™ technique (ante-
rior fundoplication): a 5-year follow-up and a multicenter prospective study. A pre-
liminary study examined GERD-related symptoms and PPI use in 13 patients within
5years after surgery: GERD-related symptom scores returned to normal in 92% of
patients, and PPI use was stopped or halved in 77% of patients (54% completely
stopped PPI).
Only three prospective randomized controlled trials of TIF and muse were pub-
lished. They compared the 6-month efcacy of TIF or omeprazole: one found that
TIF was more effective than PPI in the treatment of reux and extraesophageal
symptoms (97% and 50%, respectively, P=0.006); in the second intention to treat
analysis, TIF was more effective than PPI in eliminating GERD symptoms (67% vs.
45%, P=0.023). These differences require additional randomized studies to clarify
the efcacy of TIF in GERD.The third study compared the results of TIF and
Nissen fundoplication at 3 and 12months and showed that TIF was as effective and
safe as the Nissen method, but the length of hospital stay was signicantly shorter
(2.9±0.8 D vs. 6.4±0.7 D, P<0.0001).
2.3 Instrument forEndoscopic Gastric Fundus Suture
or Folding
2.3.1 Endo Clinch Stitching Device by Bard
The Endo Clinch suture system (Bard Endoscope Technologies, N.J.) is attached to
the end of a standard exible endoscope and has a cavity that sucks tissue and folds.
Tag protects the submucosal tissue and lowers the suture system to GEJ, and sutures
the adjacent area below LES, where the two sutures are opposite each other to cause
gastric creases. Tightening the wrinkled tissue of GEJ and LES can form a valve
that acts as a barrier against GERD.Additional folds may also be made below the
sphincter. Although the procedure has good safety, it lacks long-term efcacy and is
no longer mass-produced (Fig.2.6).
2.3.2 Plication ofNdo Plicator
The Ndo Plicator (Ndo Surgery Inc., Manseld, Mass.) was designed to create a
transmural, full-thickness, serosa-to-serosal fold at His angle below the GEJ, which is
done directly, retrograde, and visually in the instrumentation channel of the children’s
gastroscope. A pre-conditioned, suture-based pad is sent to the area between the ante-
rior wall of the stomach and the bottom of the stomach for folding (Figs.2.7 and 2.8).
2 Endoscopic Fundoplication forGastroesophageal Reux Disease
28
Fig. 2.6 Diagram of Endo
Clinch
Fig. 2.7 Diagram of
plication
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Fig. 2.8 Diagram of plication operation
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30
2.3.3 Medigus SRS Device fromIsrael
MUSE was called the SRS system in its previous version. Medigus SRS (Omar,
Israel) minimally invasive GERD (gastroesophageal reux disease) treatment sys-
tem includes a suture device, a camera, and an ultrasonic aiming device to facilitate
alignment. The system uses the advanced technology of LED lighting and one of the
smallest cameras in the world to achieve enhanced digital resolution and improved
vision. Besides, the new system has a more compact console, an electric stapler
ejection mechanism, software control to ensure safe operation, and a positioning pin
mechanism to ensure accurate alignment before the stitcher is launched. These new
features complement existing ultrasound guidance and ease of operation, making
single operator surgery possible. The endoscope should be used for one time to
ensure the safety of patients (Figs.2.9 and 2.10).
Fig. 2.9 Diagram of Medigus SRS
Fig. 2.10 Diagram 2 of Medigus SRS
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2.3.4 EsophyX Device
EsophyX is a device that can perform gastric fundus folding in the cavity, which is
composed of control handles, a tubular reductor that passes through the endoscope,
a retractable mold at the front end of the device, spiral-shaped traction needles, a
puncture needle, and a reinforcement that can extend out of the side hole of the
reductor (Figs.2.11 and 2.12).
Fig. 2.11 Diagram of EsophyX
2 Endoscopic Fundoplication forGastroesophageal Reux Disease
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Fig. 2.12 Diagram 2 of EsophyX
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