pneumatic Balloon dilatation versus pneumatic Balloon dilatation after botulinum toxin injection for the treatment of idiopathic achalasia دکتر علیرضا غمخوار استاد راهنما جناب آقای دکتر جواد میکائیلی ID: 907980
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Slide1
Slide2Long
term
Outcomes of pneumatic Balloon dilatation versus pneumatic Balloon dilatation after botulinum toxin injection for the treatment of idiopathic achalasia
دکتر علیرضا غمخوار
استاد راهنما: جناب آقای دکتر جواد میکائیلی
استاد مشاور: جناب آقای دکتر رضا ملک زاده
Slide3مقایسه اثر طولانی مدت دو روش درمانی دیلاتاسیون پنوماتیک با بالون و دیلاتاسیون با بابالون پس از تزریق توکسین بوتولینیوم در درمان آشالازی ایدیوپاتیک
Slide4This study was founded by the DDRI (Digestive Disease Research Institute), Tehran University of Medical sciences
Slide5ESOPHAGEAL MOTILITY DISORDERS
There are only 3 firmly established primary esophageal motility disorders:
AchalasiaDistal esophageal spasm (DES) GERD
Slide6Achalasia
Achalasia is characterized by impaired LES relaxation with swallowing and aperistalsis in the smooth muscle esophagus
Slide7Achalasia
Physiologic alterations result from damage to the innervation of the smooth muscle segment of the esophagus (including the LES)
Loss of ganglion cells within the myenteric plexusDegeneration of the vagus nerveDegeneration of the dorsal motor nucleus of the vagus
Slide8Achalasia
Partial preservation of the postganglionic cholinergic pathway is suggested by the observations that an achalasic’s LES pressure:
Increases after administration of the AChE inhibitor edrophoniumDecreases after administration of the muscarinic antagonist atropineThese observations are crucial to understanding why botulinum toxin may have therapeutic benefit in achalasia
Slide9Clinical Features
Clinical manifestations of achalasia:
DysphagiaRegurgitationChest painWeight lossHiccupsHalitosisAspiration pneumonia
Slide10Diagnostic workup
Clinical Manifestations
EndoscopyContrast ImagingEsophageal Manometry (High-Resolution Esophageal Pressure Topography)
Slide11Chicago Classification of Esophageal Motility Disorders
Slide12Diagnosis
Slide13Management
The underlying neuropathology of achalasia cannot be corrected
Treatment is directed at compensating for The poor esophageal emptying and Preventing complications
Slide14Management
In practical terms, this amounts to reducing LES pressure so that gravity promotes esophageal emptying
LES pressure can be reduced by pharmacologic therapy, botulinum toxin injection, forceful dilation, or surgical/endoscopic myotomy
Slide15Management
Which of these is the optimal approach remains an issue of ongoing debate
Slide16Our Study
To take a step forward to explore this debate, in this cohort study
:We attempted to comparing of long term efficacy of PBD to PBD after botulinum toxin injection
Executability of
PBD after botulinum toxin injection
and its durability
for frail individuals who are poor risks for definitive treatments
Slide17Methods
Diagnosis was made by:
Clinical evaluationEsophagographyManometry
Slide18Methods
Eighty patients with idiopathic achalasia in Shariati Hospital since 2007 to 2011 were enrolled
These patients were subdivided to two equal groups according to defined criteria
Slide19Methods
Forty patients with
dilated esophagus, Hx of surgical myotomy, or resistant to PBD enrolled in Botox plus PBD
group
Forty patients without these criteria, enrolled in P
BD
group
Slide20Methods
In the BT-PBD group:
500 U of botulinum toxin was injected through a sclerotherapy needle into each quadrant of the LESDilatation was performed using the balloons at the size of 30 mm for subsequent four weeks
Slide21Methods
In the BT-PBD group:
Dilation was continued in a graded fashionFor patients developing relapse this protocol was repeated
Slide22Methods
In the PBD group:
Dilatation was performed using the balloons at the size of 30 mmFor subsequent relapsing dilation was performed using the balloons 35 mm and 40 mm, respectively (graded gradual
approach)
Slide23Methods
The efficacy was evaluated by a questionnaire concerning:
Patient’s symptoms Timed Barium EsophagogramManometryClinical relapse was defined as a
achalasia symptom
score greater than
4
Slide24Methods
Total clinical score:
Before treatment and 1.5, 3, 6 , 9, and 12 months after treatment TBE:Before treatment and 1, 6 , 12, and 24 months after treatmentManometry:
Before
treatment
Slide25Methods
TBE:
X ray was taken 1, 3, and 5 min after swallowingHeight of barium column was measured in centimeters The volume of retained barium was calculated
Slide26Methods
Follow up time:Minimum follow up time: 8 months
Maximum follow up time: 132 months
The mean follow up time: 76.40 months
Slide27Clinical evaluation
A structured interview evaluating the severity of esophageal symptoms was conducted on the basis of
Five clinical symptoms:Solid and liquid dysphagiaActive and passive regurgitation Chest pain, and
Severity of dysphagia
Slide28Clinical evaluation
Symptoms
None
Weekly
Daily
Each Meals
Dysphagia to solids
0
1
2
3
Dysphagia to liquids
0
1
2
3
Active regurgitation
0
1
2
3
Symptoms
None
Monthly
Weekly
Daily
Passive regurgitation
0
1
2
3
Chest pain
0
1
2
3
Slide29Clinical evaluation
Severity of Dysphagia
No dysphagia
0
Normal passage of food from LES zone
Mild dysphagia
1
Sensation or short delay of passage of
food from LES, without need of water
Moderate
dysphagia
2
Need of
water for passage of food from LES zone
Severe dysphagia
3
Accompanied with passive or active regurgitation
Slide30results
Slide31results
There was no significant difference between the groups for sex (P= 0.824)
Slide32Results: AGE
Group
Mean
Nombur
Std Dev.
Min
Max
P value
P
BD
35.50
40
12.308
15
65
0.415
BT-P
BD
38.03
40
15.372
14
82
There was no significant difference between the groups for age (P= 0.415).
PBD: Pneumatic Balloon Dilation
; BT-PBD: Botulinum Toxin-
Pneumatic Balloon Dilation
Slide33P
B
D
Group
ASS
(
Achalasia Symptom Score)
Mean
Std
Deviation
P Value
ASS before treatment
10.31
3.079
0.0001
ASS 1 month after treatment
2.46
2.563
ASS 6 months after treatment
2.21
3.033
ASS 12 months after treatment
1.24
2.712
ASS 24 months after treatment
1.11
3.016
Height
Mean
Std
Deviation
P Value
Height before treatment
8.29
8.269
0.007
Height 1 month after treatment
1.29
4.268
Height 6 months after treatment
2.71
6.366
Height 12 months after treatment
0.59
2.25
Height 24 months after treatment
1.00
3.606
Volume
Mean
Std
Deviation
P Value
Volume before treatment
62.93
77.60
0.027
Volume 1 month after treatment
6.67
21.13
Volume 6 months after treatment
16.64
48.96
Volume 12 months after treatment
6.27
30.50
Volume 24 months after treatment
6.17
18.05
Slide34Comparing Height in P
BD
and BT-PBD groups
PBD: Pneumatic Balloon Dilation
; BT-PBD: Botulinum Toxin-
Pneumatic Balloon Dilation;
(P value = 0.021)
Slide35Comparing Volume in P
BD
and BT-PBD groups
Slide36BT-P
B
D
Group
ASS
(
Achalasia Symptom Score)
Mean
Std
Deviation
P Value
ASS before treatment
10.53
2.810
0.0001
ASS 1 month after treatment
4.43
3.441
ASS 6 months after treatment
4.05
2.856
ASS 12 months after treatment
3.76
2.804
ASS 24 months after treatment
3.86
3.425
Height
Mean
Std
Deviation
P Value
Height before treatment
8.88
5.214
0.013
Height 1 month after treatment
7.43
6.176
Height 6 months after treatment
5.05
5.246
Height 12 months after treatment
3.80
5.164
Height 24 months after treatment
3.55
4.947
Volume
Mean
Std
Deviation
P Value
Volume before treatment
59.00
40.001
0.021
Volume 1 month after treatment
35.36
30.348
Volume 6 months after treatment
25.93
36.766
Volume 12 months after treatment
23.50
33.808
Volume 24 months after treatment
18.11
26.643
Slide37Balloon Numbers
Group
Balloon Size
Time
P
B
D
BT-P
B
D
Total
P Value
3
cm
1st
3
7
29
66
2nd
1
7
8
3rd
0
1
1
Total
3
3
8
37
75
0.04
Group
Balloon Size
Time
P
B
D
BT-P
B
D
Total
P Value
3.5 cm
1st
1
6
1
4
30
2nd
2
9
1
1
3
rd
3
0
3
Total
3
21
23
44
0.023
Group
Balloon Size
TimePBDBT-PBDTotalP Value4 cm1st37102nd112Total248120.576
The difference in balloon number was meaningful between the two groups and it was significantly high in the BT-
P
B
D
group.
Slide38Cumulative remission rate in Kaplan–Meier plot
.
Patients treated with botulinum toxin (BT) + pneumatic dilatation (PD) compared with pneumatic dilatation (PD) alone. Mean time for remaining in remission
at PD group was 49.8 months and at BT-PD group was 108.09 months (p: 0.001)
.
Slide39Discussion
Slide40Discussion
P
BD has traditionally been regarded as the treatment of choice by most gastroenterologist, but: It is clearly not perfectUnder certain condition, this method can not be used
Slide41Discussion
Mikaeli et al. compared the two methods in the short term (12 mon.) with 34 patients
A group of patients who were low responder to two initial PBDThey were concluded that BT-PBD was more effective than PBD
, but the difference was not significant
In our study, this difference was significant
Bakhshipour A
,
Rabbani R
,
Shirani S
,
Soleimani HA
,
Mikaeli J
.
Comparison of pneumatic dilation with pneumatic dilation plus botulinum toxin for treatment of achalasia. .
Acta
Med Iran;
2010 Mar-Apr;48(2):107-10
Slide42Discussion
A study conducted by Zaninotto et al. in Italy and published in 2004
Eighty patients in two groups of 40 were underwent surgery and 40 treated with Botox injectionsIn the follow up of two years, 85% of the surgical group and 34% in the Botox group were asymptomatic
Zaninotto et al. Randomized Controlled Trial of Botulinum Toxin Versus Laparoscopic Heller Myotomy for Esophageal Achalasia. Annals of Surgery. 2004; 239: 3
Slide43Discussion
In a study by Oiang et al in China, the results of which were published in 2009, 90 patients were examined in three groups:
The Botox groupThe balloon dilatation group, and The combination group of these two methods
Qiang
Zhu
Jiyong
Liu
Chongmei
Yang. Clinical Study on Combined Therapy of Botulinum Toxin Injection and Small
B
alloon Dilation in Patients with Esophageal Achalasia. Dig
Surg
2009;26:493-498.
Slide44Discussion
At 2 years after treatment:
The response rate in BT-PBD group remained 56.67%It was significantly greater than any of the two other groups (p < 0.05)This finding is consistent with our research findings
Qiang
Zhu
Jiyong
Liu
Chongmei
Yang. Clinical Study on Combined Therapy of Botulinum Toxin Injection and Small
B
alloon Dilation in Patients with Esophageal Achalasia. Dig
Surg
2009;26:493-498.
Slide45Discussion
In a study from 1998 to 2007 by Kroupa et al. in the Czech Republic, the results of which were published in 2010
, 51 patients were enrolled Each patient received injection of 200 IU of BT into the LES during endoscopy and 8 days later PBD
R. Kroupa, et al. Combined treatment of achalasia – botulinum toxin injection followed by pneumatic dilatation: long-term results. Diseases of the Esophagus (2010) 23, 100-105
Slide46Discussion
Results were compared with 40 historical controls treated by PD alone
The mean duration of follow-up was 48 months with range 12–96 monthThe cumulative 5 years remission rate in combined treated patients was higher than in controlsHowever, it was not statistically significant ( P= 0.07)
R. Kroupa, et al. Combined treatment of achalasia – botulinum toxin injection followed by pneumatic dilatation: long-term results. Diseases of the Esophagus (2010) 23, 100-105
Slide47Discussion
We did, however, in our study by studying on the two groups and having a more accurate comparison of the differences between these two combination treatments:
In our study, this difference was significantR. Kroupa, et al. Combined treatment of achalasia – botulinum toxin injection followed by pneumatic dilatation: long-term results. Diseases of the Esophagus (2010) 23, 100-105
Slide48discussion
Mikaeli et.al, performed a study to assess whether botulinum toxin injection before PBD is superior to PBD lone in achalasia patients
Achalasia patients were randomly assigned to receive Botox 1 month before PBD or to undergo PBD alone (27/27)Parameters of response were studied over 1 yearThey concluded that injection of Botox before PBD does not significantly enhance the efficacy of pneumatic dilatation
MIKAELI, et.al; Injection of botulinum toxin before pneumatic dilatation in achalasia treatment: a randomized-controlled trial
2006; Aliment Pharmacol Ther 24, 983–989
Slide49discussion
Neubrand et al. in 2002 in Germany,
retrospectively studied 25 patients with achalasiaPatients were all treated with BotoxIt was found that the effectiveness of this method was significantly higher in those who were olderIn our study, the treatment outcome was not significantly affected by the age of patients
Neubrand M, et al. Long-term results and prognostic factors in the treatment of achalasia with botulinum toxin. Endoscopy. 2002;34(7):519-523
Slide50Conclusion
According to the findings of this study:
Both PBD therapy and balloon dilatation after botulinum toxin injection (BT-PBD) are effectiveBT-PBD protocol is
feasible in high risk groups
BT-PBD protocol can reduce the need of surgery for the patients who are resistant to PBD
Slide51Conclusion
It is advisable to recommend combination approach
In patients with idiopathic achalasiaEspecially in those:
Who are at risk for PBD
Resistent
to PBD
Have comorbid disorders
Surgery is not feasible
Slide52