THE AMERICAN JOURNAL OF GASTROENTEROLOGY
7, 1998
Copyright © 1998 by Am. Coll. of Gastroenterology
Published by Elsevier Science Inc.
Pneumatic Balloon Dilation in Achalasia: A Prospective
Comparison of Balloon Distention Time
Anwaar A. Khan, M.D., F.A.C.P., F.A.C.G., S. Waqar H. Shah, M.B.B.S., Altaf Alam, M.R.C.P.,
Arshad K. Butt, F.C.P.S., Farzana Shafqat, F.C.P.S., and Donald O. Castell, M.D., F.A.C.P., F.A.C.G.,
Department of Gastroenterology, Shaikh Zayed Postgraduate Medical Institute, Lahore, Pakistan, and The Graduate Hospital,
Philadelphia, Pennsylvania
Objective: Duration of Inflation in pneumatic balloon
dilatation as treatment of achalasia has been variable
ranging from 15 s to 6 min. A 60 s duration appears to
be most often used. We compared the efficacy of dilation
of achalasia with either 6- or 60-s inflation duration
using a Rigiflex dilator of 3.0 cm diameter. Methods:
Eighty-one consecutive patients were prospectively stud-
ied in a randomized fashion, 41 in the 60-s group (A) and
40 patients in the 6-s group (B). Mean age of group A
was 43 6 16.2 yr and of group B was 40 6 16.4 yr.
Symptoms of dysphagia, chest pain, heartburn, regurgi-
tation, and night cough were evaluated at basal (before
dilation), 1- and 6-month intervals after dilation in both
groups. Barium swallow was done to assess esophageal
emptying 1 wk before dilation and 5 min postdilation in
both groups. Results: Significant and sustained improve-
ment was seen for all symptoms in both groups. In
addition, the degree of improvement in symptom scores
between the two groups was similar. Barium esopha-
gram in both groups at basal and immediately postdila-
tion showed significant improvement in barium empty-
ing but there was no significant difference between the
two groups, indicative of equal efficacy in both disten-
tion times. Two patients needed repeat dilatation in
group A and one in group B, with one drop out from
group A, who was lost to follow-up, and was excluded
from the analysis. No perforation occurred. Conclusion:
Short duration of pneumatic balloon dilatation (6-s) is as
effective as longer duration (60-s) in treatment of
achalasia. (Am J Gastroenterol 1998;93:1064 –1067. ©
1998 by Am. Coll. of Gastroenterology)
INTRODUCTION
Pneumatic dilatation in patients with idiopathic esopha-
geal achalasia is generally considered to be the procedure of
choice. Effective interruption of circular muscle fibers of the
lower esophageal sphincter (LES) is the theoretical basis for
pneumatic dilation. Appropriate duration of dilation, how-
Received Jan. 21, 1997; accepted May 7, 1997.
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ISSN 0002-9270/98/$19.00
PII S0002-9270(98)00211-1
ever, has not been established, with intervals between 15 s
and 6 min being used (1). The common practice of keeping
the balloon inflated for 60 seconds has been primarily on
empirical grounds. We, therefore, compared the efficacy
and safety of 6-s dilation, sufficient time to obliterate the
balloon waist, with 60-s duration, as conventionally done.
Inasmuch as dilation is potentially hazardous because of the
risk of perforation and is painful despite the use of medi-
cations for amnesia, a secondary goal was to reduce the
complication rate. Many types of balloon dilators have been
used, including the Brown McHardy, Hurst Tucker, Mosher,
and Rider Moller instrument. Recently, Rigiflex (Microva-
sive, Watertown, MA) has become more popular because of
ease of use and safety features (2, 3). We therefore used this
dilator with a 30-mm diameter in all of our patients.
MATERIALS AND METHODS
A total of 89 patients were initially screened for this study
from 1989 through 1994. Eight patients with extremely
dilated esophagi were excluded from the study because,
presumably, effective emptying of barium pre- and postdi-
lation would have been markedly impaired and thus would
not be comparable with that of other patients studied. The
remaining 81 consecutive patients, were randomly assigned,
41 (31 men, 10 women) in group A and 40 (19 men, 21
women) in group B. The diagnosis of idiopathic achalasia
was based on clinical symptoms (predominantly dysphagia),
barium swallow, and manometric criteria. In addition, en-
doscopy was performed in all patients to rule out secondary
achalasia.
Esophageal manometry was evaluated by one of two
physicians (A.A.K., S.W.H.S.) using an 8-lumen polyvinyl
catheter, a low compliance pneumohydraulic capillary per-
fusion system (Arndorfer medical specialities, Greendale,
WI) and a recording physiograph (Hewlett Packard, Chi-
cago, IL). Lower esophageal sphincter (LES) pressure was
measured at the maximal end expiratory phase as the mean
value obtained from the slow pull-through of four radially
placed orifices, oriented at 90° angles 1 cm apart. Four
additional orifices, located 5 cm apart and oriented at 90°
angles, were used for measuring pressures in the esophageal
AJG – July 1998
body by placing the distal orifice 3 cm above the LES. Ten
wet swallows (5 ml of water) were performed to assess
esophageal peristalsis.
Diagnostic criteria required for achalasia were aperistalsis
of the esophageal body, incomplete relaxation of the LES
(residual pressure . 5 mm Hg), and typical barium esopha-
gram.
A diary for symptoms was maintained by all patients, and
was evaluated by a physician who, at 1 and 6 months
follow-up, was unaware of the specific details of the pneu-
matic dilatation. Symptom severity of dysphagia, chest pain,
regurgitation, night cough, and heartburn was scored by the
physician on a 0 –3 scale (0 5 none, 1 5 mild, 2 5
moderate, 3 5 severe). Total score was added as the com-
posite score (maximum # 15 for each patient).
Barium swallow was performed by a consultant radiolo-
gist who was blinded to the type of dilation procedure
performed. Typical features of achalasia i.e., dilatation of
the esophageal body, absence of definitive peristalsis, and
smooth narrowing at the distal esophagus was noted in all
patients. Emptying of the esophagus was tested by having
the patient swallow 100 ml of barium in the standing posi-
tion. The estimated percentage emptying of the esophagus
was evaluated for 5 min. Less than 50% emptying was
considered impaired and .50% was considered effective
emptying. Barium swallow was repeated 5 min after dilation
primarily to detect perforations or tears, but also to assess
emptying. Width and length of barium column in pre- and
postdilatation barium swallow was also measured to objec-
tively assess the effective emptying of the esophagus.
Dilatation of the LES was accomplished by passing the
wire-guided balloon (Microvasive) across the gastroesoph-
ageal junction under fluoroscopic control and placing the
balloon center at the level of diaphragm. The balloon was
slowly inflated so that the indentation or “waist” created by
the LES was identified and positioned in the center of
balloon. The balloon was then rapidly inflated to 30 mm
diameter to a pressure of 10 psi, and inflation was main-
tained at this pressure for 60 s in group A and for 6 s in
group B. A pressure limit of 10 psi was selected because an
earlier study (4) had suggested inflation pressure $11 psi
was an independent risk factor for possible complications of
pneumatic dilatation. In each case complete obliteration of
the waist was achieved with diameter reaching 30 mm.
Out-patient follow-up was carried out at 1- and 6-month
intervals after dilation for evaluation of symptom scores as
recorded in the diary by the patients. This study was ap-
proved by the institutional review board of the Shaikh Zayed
Hospital, Lahore, and informed consent was obtained from
all the patients studied.
Statistical analysis
Friedman’s two way ANOVA was used to compare the
overall improvement in symptom scores at basal, 1-month,
and 6-month intervals for the entire sample of 81 patients
and for within-group evaluation of groups A and B. The
PNEUMATIC BALLOON DILATION 1065
TABLE 1
Demographic Features
Group A Group B
Male 32 30
Female 9 10
Age 43 6 16.2 40 6 16.4
Duration of symptoms (in months) 43 6 32 37 6 21
Height of barium, pre dilatation (cm) 13.0 6 4.3 16.2 6 5.4
Height of barium, post dilatation (cm) 7.0 6 2.0 7.2 6 4.1
Width of barium, pre dilatation (cm) 6.3 6 3.3 4.8 1 1.8
Width of barium, post dilatation (cm) 65.1 6 3.9 3.2 6 1.6
Symptom score, baseline 4.4 6 0.8 4.09 6 0.79
Symptom score, 1 month 0.87 6 0.20 0.747 6 0.17
Symptom score, 6 months 0.29 6 0.07 0.43 6 0.08
All data except gender (male, female) given as mean 6 SD.
Wilcoxon matched pairs signed rank test was used for
calculation of Z-scores for basal versus 1-month, basal ver-
sus 6-month, and 1-month versus 6-month scores both for
the entire sample and within group analysis. Wilcoxon
matched pairs signed rank test was also used for analysis of
barium height and width before dilation and 5 min after
dilation. Kruskal-Wallis one way ANOVA was used for
comparison between two groups to evaluate basal, 1-month,
and 6-month composite scores. For all analyses, a p value
#0.05 was considered significant.
RESULTS
Demographic features are presented in Table 1. Mean
scores for dysphagia, chest pain, regurgitation, night cough,
and heartburn in both groups A and B at basal, 1-month, and
6-month intervals are shown in Table 2. Mean total scores
in the 81 patients showed overall improvement from a basal
score of 4.36, to 1-month score of 0.81 and 6-months score
of 0.35 (p , 0.001), confirming the overall efficacy of
pneumatic balloon dilation in relieving symptoms of acha-
lasia (Fig. 1). Comparison of mean dysphagia scores in
groups A and B showed similar improvement between basal
and both 1-month and 6-month scores (Fig. 2).
Pairwise comparison of mean scores between groups A
and B at baseline, 1 month, and 6 months did not reveal a
significant difference (p 5 0.21, 0.40, and 0.25 respectively)
showing that the samples were comparable at basal level and
efficacy of dilatation was also comparable in both groups.
The results of barium swallow also showed improvement
in both groups when compared at basal and 5 min postdi-
lation periods (Table 1). Height of barium column decreased
from a mean value of 13.0 6 4.3 cm before dilation to 7.0 6
2.0 cm postdilation (p , 0.001) in group A, whereas in
group B it decreased from 16.2 6 5.4 cm predilation to
7.2 6 4.1 cm postdilation (p , 0.001). Width of barium did
not show a significant reduction in pre- and postdilation
values in group A (p . 0.05) and group B (p . 0.05).
Thirty-five patients (85.4%) in group A showed effective
emptying after dilatation versus 35 patients (88.4%) in
1066 KHAN et al. AJG – Vol. 93, No. 7, 1998
TABLE 2
Mean Scores for Clinical Parameters Recorded

Group A Group B
Variables
Basal 1 Month 6 Months Basal 1 Month 6 Months
Dysphagia 2.45 0.47 0.21 2.34 0.40 0.24
Pain 0.34 0.03 0.03 0.24 0.02 0.02
Regurgitation 1.03 0.00 0.00 0.85 0.00 0.05
Night cough 0.13 0.00 0.00 0.20 0.00 0.00
Burning 0.50 0.37 0.05 0.46 0.32 0.12
Total score 4.45 0.87 0.29 4.09 0.74 0.43
For all variables scoring was done as follows: 0 5 none; 1 5 mild; 2 5 moderate; and 3 5 severe.

transient improvement. The clinical and demographic fea-

tures of these patients were similar to those of others before
dilation. One patient dropped out of group A and he was lost
to follow-up; his exclusion from the analysis did not change
significance of the results. No perforation was encountered
in any patient. Thirty-two patients in group A (80%) and 35
in group B (85%) were dilated as outpatients.

DISCUSSION

Selection of duration for balloon dilation in the treatment

FIG. 1. Comparison of mean basal, 1-month, and 6-month total symptom
scores.
FIG. 2. Comparison of mean basal, 1-month, and 6-month dysphagia
scores.
group B. The difference was not statistically significant
(p 5 2.65).
Two patients in group A (5%) and 1 in group B (3%)
needed repeat dilation within 6 months. One of these pa-
tients in group A needed repeat dilatation after 1 month
because of persistence of original symptoms, the other was
redilated after 5 months because recurrence of original
symptoms to baseline total score with transient initial relief.
In group B, one patient required repeat dilation after 3
months because of worsening of dysphagia score after initial
of achalasia (i.e., the time for which the dilator stays in-
flated) has been arbitrary and many durations are used.
Repeat dilation, immediately after the first dilation has been
performed with the premise that it will provide better results
(3), but this was not shown to be of added advantage by
Wong and colleagues (5). When low pressure was used for
inflation, the need for repeat dilation was seen in 50% of
cases and use of higher than 15 psi resulted in ,10% repeat
dilatation rate (6). The duration of inflation was however,
not emphasized to have a bearing on repeat dilation rate.
In this study, we have completed the first prospective
randomized comparison of brief (6-s) versus more pro-
longed (60-s) duration of balloon inflation during pneumatic
dilation for achalasia. This study was conducted because we
believed that obliteration of the “waist” produced by the
sphincteric impression on the inflated bag represented a
reasonable end point to the procedure. Because this is usu-
ally accomplished almost immediately, we postulated that a
6-s dilation should provide results that were as effective as
the more commonly used longer inflation interval. Indeed,
our study seems to support this hypothesis, inasmuch as
both study groups had significant improvement in symp-
toms compared with their baseline levels and showed no
difference in the level of improvement when comparing the
1- and 6-month postdilation results between the groups.
Although follow-up was limited to 6 months, the sustained
improvement indicated some degree of prolonged symptom
relief.
Adequacy of dilatation is often gauged by relief in dis-
abling symptoms and its failure requires repeat dilation or
surgery. Need for repeat dilation is believed to indicate that
the initial dilation may not have adequately disrupted the
circular fibers of the LES. Two patients needed repeat
AJG – July 1998
dilation in group A and 1 in group B; this yielded a 6-month
success rate of 95% and 97%, respectively, comparable with
other published results (7).
We used a 30-mm balloon dilator with 10 psi in both
groups so that variation in size and pressure would not
influence the results. We excluded patients with massively
dilated and tortuous esophagi from the study because we
believe that this represents an end stage disease with a
relatively nonfunctioning organ. The reason to exclude these
patients was also to eliminate the bias for obvious slow
emptying of barium in barium swallow. These patients are
difficult to treat with a larger diameter balloon or even
myotomy. Symptomatic relief is often not attainable by
these techniques and these patients are more likely to be
candidates for esophagectomy (8). One should also note that
the patients in our study were predominantly treated in an
ambulatory setting; 32 patients in group A (80%) and 35 in
group B (85%) had their procedure completed as outpa-
tients.
We conclude from the results of our study that short
duration balloon inflation, in this case 6 s, is enough to
achieve effective dilation in achalasia. To date, there has not
been a common consensus on duration of inflation in the
literature, creating controversy that we hope will be resolved
by our results. We also observed that esophageal balloon
dilation, in most cases, can safely be performed on an
out-patient basis, thus containing hospital costs.
PNEUMATIC BALLOON DILATION 1067
ACKNOWLEDGMENTS
The authors thank Dr. M. A. Rahim Khan, Dr. M. Saeed,
and Mr. Pervaiz for assistance in the radiology department,
and Mr. Asghar Ali Anjum for typing the manuscript.
Reprint requests and correspondence: Anwaar A. Khan, M.D., F.A.C.P.,
F.A.C.G., Professor of Gastroenterology, Shaikh Zayed Postgraduate Med-
ical Institute, Lahore, Pakistan.
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