0016-5107/91/3706-0670$03.
00
GASTROINTESTINAL ENDOSCOPY
Copyright © 1991 by the American Society for Gastrointestinal Endoscopy
Technology assessment status evaluation:
endoscopic band ligation of varices
In order to promote the appropriate use of new or
emerging endoscopic technologies, the A/S/G/E
Technology Assessment Committee has developed a
series of status evaluation papers. By this process,
relevant information about these technologies may be
presented to practicing physicians for the education
and care of their patients. In many cases, data from
randomized controlled trials is lacking and only pre-
liminary clinical studies are available. Practitioners
should continue to monitor the medical literature for
subsequent data about the efficacy, safety, and socio-
economic aspects of these technologies.
BACKGROUND
The treatment of esophageal variceal bleeding due
to portal hypertension has continued to evolve. Within
the last decade, sclerotherapy has become the first
line and often the definitive treatment for variceal
bleeding. 1,2 Sclerotherapy is less invasive than surgery
and highly effective for the control of active bleeding. 3
Obliteration of variceal channels may be achieved in
75% of patients with repeated treatment sessions. 4 ,5
Complications of sclerotherapy, however, occur in
up to 20% or more of patients. 6 These include chest
pain, fever, pleural effusion, bacteremia, esophageal
perforations, and strictures. In an attempt to reduce
the incidence of complications, a new technique em-
ploying a different principle has been explored. Based
on the technique of band ligation of hemorrhoids, band
ligation of esophageal varices has been developed and
adapted for use with the flexible endoscope. Unlike
sclerotherapy, no chemical inflammation is induced,
and the potential systemic toxicity of sclerosants is
avoided. 7
The mechanism of thrombosis and obliteration of
esophageal varices treated by band ligation has been
studied in a dog model. 8 The banded varix undergoes
strangulation; the resulting venous obstruction and
stasis leads to thrombosis with subsequent fibrosis.
The band itself and the strangulated tissue slough
within 24 to 72 hours. Ulceration follows sloughing,
but is uniform in size and depth, usually extending to
the submucosa.
EQUIPMENT
The variceal ligator is commercially available as a
disposable attachment and can be slipped onto the tip
670
of most flexible endoscopes. 9 It has three components:
a housing cylinder (the part that slips over the endo-
scope), a banding cylinder pre-loaded with a rubber 0
ring that fits concentrically within the housing cylin-
der, and a trip wire which operates the banding cyl-
inder. The housing cylinder is attached to the tip of
the endoscope. The trip wire is inserted through the
biopsy channel and then secured to the banding cyl-
inder at a preformed notch. As the trip wire is pulled,
the banding cylinder moves inside the housing cylin-
der, releasing the 0 ring over the pedicle of the varix.
Since after each ligation the device has to be removed
for reloading, multiple passes of the endoscope are
necessary. A short (25-cm) overtube, pre-mounted
over the endoscope in order to stent the cricopharyn-
geus, facilitates multiple insertions.
ENDOSCOPIC TECHNIQUE
Diagnostic endoscopy is first performed. If an ac-
tively bleeding varix is found at the preliminary as-
sessment, it is ligated first. Otherwise the varices are
initially ligated at the gastroesophageal junction or
just beyond. Because banded tissue tends to obscure
the view, varices are banded starting in the distal
esophagus and moving proximally in a spiral stairstep
fashion. To perform a ligation, the target varix is
drawn into the ligation chamber with adequate suction
and the band released around its pedicle. Occasionally,
transient bleeding occurs due to rupture of the ligated
varix. An average of 5 to 10 ligations are done in the
initial session. lO
Ligation may be repeated in 7 to 14 days and then
every 2 to 4 weeks until the varices are obliterated.
SPECIFIC INDICATIONS AND EFFICACY
The indications for variceal ligation are the same
as for sclerotherapy.
For active bleeding varices, preliminary data show
that ligation is over 90% effective for hemostasis. 7,1l
For prevention of recurrent bleeding, the available
results show that ligation is effective when used over
a period of months with eradication of varices in
60 to 70% of patients. 7,1l Preliminary data from
a randomized controlled trial of ligation versus
sclerotherapy 7 showed comparable eradication rates
for the two techniques.
GASTROINTESTINAL ENDOSCOPY
 Band ligation may be potentially useful for patients
refractory to sclerotherapy,l1 but may not be suitable
in a sclerotic lower esophagus with non-pliable mu-
cosa.
Treatment of bleeding gastric varices has not been
investigated.
With regard to its ease of use, band ligation is less
demanding of pinpoint accuracy than that which may
be required with a sclerotherapy needle. Assembly of
the ligator takes minutes and the technique is simple
for physicians and their assistants to learn. With
proper training, the endoscopic maneuvering and fir-
ing of the ligating device is a skill easily acquired by
the endoscopist experienced in therapy for gastroin-
testinal bleeding.
Several potential technical problems with the band
ligation method exist. The ligation attachment may
significantly reduce the field of view due to a narrowed
visual angle. The overtube, although easy to use and
generally well tolerated by patients, may require se-
vere hyperextension of the neck during its introduc-
tion into the esophagus. Its presence also allows efflux
from the tube of potentially substantial amounts of
blood and secretions and appropriate precautions
should be taken by the endoscopist and staff in at-
tendance. Finally, it is possible for the housing or
banding cylinders to become dislodged from the en-
doscope tip and pass into the gastrointestinal tract.
SAFETY
Mortality due to banding has not been reported.
Complications due to this technique include:
Recurrent bleeding. As in sclerotherapy, there is a
substantial re-bleeding rate following banding, but
this occurs rarely after eradication of the varices.
Stiegmann et al. 11 reported 47% rebleeding after dis-
charge from the index hospitalization, but only 5 of
72 episodes occurred after eradication of varices.
Post-banding ulcers. Shallow ulcers are regularly
observed after sloughing at each ligation site and are
followed by re-epithelialization. These may be the
source of recurrent bleeding in a small percentage of
patients but most recurrent bleeding appears to come
from persistent varices. 11
Stricture. In the series of Stiegmann et al.,l1 of the
first 100 patients undergoing variceal banding, a 2%
stricture rate was reported. These were short strictures
and are readily dilated with a single pass of a dilator.
Aspiration. There is always a potential risk of aspi-
ration in briskly bleeding patients, particularly with
the cricopharyngeus splinted open. However, experi-
ence has shown that blood tends to be ejected to the
outside via the overtube if the patient should vomit. 7
Pneumonia was reported in 3% of patients who under-
went band ligation therapy in one series; the etiology
of pneumonia (e.g., aspiration versus other) was un-
clear. 7,12
VOLUME 37, NO.6, 1991
Transient dysphagia and chest pain. These symp-
toms are occasionally observed after the initial ligation
and have been attributed to esophageal spasm. Their
actual etiology has not been studied. 13
Perforation due to the overtube is a potential risk
but has not been reported to date. Similarly, perfora-
tion due to banding has not been reported. The poten-
tial problem of trauma to large varices and significant
bleeding due to overtube insertion also has not been
reported.
Other side effects seen in sclerotherapy such as
atelectasis, transient pleural effusion, fever, and bac-
teremia have not been observed with banding. Specific
consequences, if any, of ligating normal esophageal
tissue have not been reported. It is unknown whether
or not the development of gastric varices is promoted
by band ligation of esophageal varices.
FINANCIAL CONSIDERATIONS
The band ligation device is now commercially avail-
able, and has been approved by the Federal Drug
Administration for variceal ligation. The approximate
equipment cost is:
Nondisposable items:
Overtube (25 cm): $60.
Disposable items:
Kit: (five preloaded banding cylinders, one trip
wire with handle, one outer cylinder for attach-
ment to the endoscope): $50.
By comparison, the cost of supplies necessary to per-
form sclerotherapy are:
Sclerosants: Ethanolamine $200/20 ml (10 X 2-ml
vials)
1% sotradecol $30/20 ml (10 X 2-ml vials)
3% sotradecol $40/20 ml (10 X 2-ml vials)
5% sodium morrhuate $20/50 ml
Disposable injectors: $35 per injector.
Both sclerotherapy and ligation may incur identical
physician fees and fees for facility use. Band ligation
is reimbursed by third-party payers as sclerotherapy
in some geographic areas.
SUMMARY
On the basis of limited available data, band ligation
appears to be effective for control of active esophageal
variceal bleeding and for prevention of recurrent
bleeding. It has minimal morbidity and no reported
mortality. Preliminary results of a randomized-trial
comparing this technique to sclerotherapy show com-
parable efficacy but band ligation may carry a lower
complication rate. Long-term results of ligation are
pending.
REFERENCES
1. Cello JP, et al. Management of the patient with hemorrhaging
esophageal varices. JAMA 1986;256:1480-4.
2. Larson AW, Cohen H, Zweiban B, et al. Acute esophageal
variceal sclerotherapy. JAMA 1986;255:497-500.
671
 3. Burroughs AK, Hamilton G, Phillips A, et al. A comparison of results of endoscopic variceal ligation. Surg Endo 1989;3:73-8.
sclerotherapy with stapling transection of the esophagus for the 11. Stiegmann GV, Goff JS, Sun JH, et al. Endoscopic ligation of
emergency control of bleeding from esophageal varices. N Engl esophageal varices. Am J Surg 1990;159:21-6.
J Med 1989;321:857-61. 12. Saeed ZA, Michaletz PA, Winchester CB, et al. Endoscopic
4. Westaby D, MacDougall BRD, Williams R. Improved survival variceal ligation in patients who have failed endoscopic sclero-
following injection sclerotherapy for esophageal varices: final therapy. Gastrointest Endosc 1990;36:572-4.
analysis of a controlled trial. Hepatology 1985;5:827-30. 13. Goff JS, Revieille M, Stiegmann GV. Endoscopic sclerotherapy
5. Infante-Rivard C, Esnaola S, Villenueve JP. Role of endoscopic versus endoscopic variceal ligation: esophageal symptoms, com-
variceal sclerotherapy in the long term management of variceal plications, and motility. Am J GastroenteroI1988;83:1240-3.
bleeding: a meta-analysis. Gastroenterology 1989;96:1087-92.
6. Schuman BM, Beckman JW, Tedesco FJ, et al. Complications Prepared by:
of endoscopic injection sclerotherapy: a review. Am J Gastroen- Technology Assessment Committee
teroI1987;82:823-9. David A. Gilbert, MD, Chairman
7. Stiegmann GV, Goff J, Michaletz P, et al. Endoscopic variceal Robert G. Buelow, MD
ligation versus sclerotherapy for bleeding esophageal varices: Raphael S. K. Chung, MD
early results of a prospective randomized trial. Gastrointest
Endosc 1990;36:188. John T. Cunningham, MD
8. Stiegmann GV, Sun JH, Hammond W. Results of experimental P. Gregory Foutch, DO
endoscopic esophageal varix ligation. Am Surg 1988;54:113-8. Loren A. Laine, MD
9. Stiegmann GV, Cambre A, Sun JH. A new endoscopic elastic Patrice A. Michaletz, MD
band ligating device. Gastrointest Endosc 1986;32:230-3. Gary Zuckerman, DO
10. Stiegmann GV, Goff JS, Sun JH, et al. Technique and early February 1991

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