loll

Somatostatin versus Sengstaken balloon tamponade for primary haemostasia of bleeding esophageal varices A randomized pilot study

In Ibis study we evaluate the ef’icacy of somatostatie (ST) versusballoon tamponade (BT) in controlling bleeding from esophagealwrites. Fortyfour consecutivepatients with active wriceal bleeding were randomly assignedto treatment ~‘~th~~ont~noo~~infilcinnof STat 25fl&hafteran initial bolusof5O~g(groupA)ortotreatmentwithBT(groupB). Five casts were excluded from the final analysis becauseof methodological issues.Nineteen patients were allocated to group A and twenty ro group B. No differ’cncesin age, sex. alcohol intake. severity of bleeding or liver failure were found between the S:oups. Init,d haemostasiawthin the first 4 h of treatment we6 obtained in 14 (74%) of the patients receiving STand in i? (@ZIP/a) of [hose receiving BT. Three patients in group A and two in group B had early rebleeding. Bleeding was controlled over a 24-h period or until elective sclerotherapy could be performed in 11 (58%) and 10 (50%) of the Patients, in groups A and B. respectively. One BT-treated patient developed aspiration pneumonia. No complications were observed in patients treated with ST. No significant differences in inidol haemostasia,definite control of bleeding or complications v,crc found between the two groups. In this study. somatostatin infusion was found to be as effective as ScagstakenBT in controlling xutc variceill bleeding until an elective sessionof endoscopicsclerotherapy could be performed. However, !a:gcr studiesare still needed to confirm this theory.

Intr”duction The aim of treatment of esophagealvariceal bleeding is rapid haemostaaiaand the prevention of haemorrhage recurrence. Both curgcry and endoscopic sclerotherapy have proved effective. Balloon ramponsde and vasoactive drugs have also proved effective as temporary mothods since the incidence of recurrence is high after treatment is discontinued (l-9). Esophageal balloon tamponade is uncomfortable for the patient u ~1 is sometimesresponsihlefor a number of severecamp :ations (l-4). Somatoswin has been ~bown to be sim or to vasopressin and injection scleruthrrapy for cantrolhng acute variceal bleeding (7-10) Although some data from the literature

suggestthat balloon tamponade could be more effective than somatostatin, no controlled studies comparing these two treatments have been carried out. The aim of this randomized study was to compare the efficacy between somatostatin and balloon tamponade in the treatment of acute variceal bleeding.

Patientsand h:et ,nds Patients Patients, admitted coosccutivelytc our unit with a diagnosis of variceal bleeding between February lh, 1997 and February 15. 1988. wre included in this study. They were

required to fulfil orw ,>I the fallowing

,.ritcria:

(i) Active

bleeding from varices seen during endoscopy. early after admission. (ii) Rebleeding

from varices while in the has-

pital (red haematemesis or frenlient

melamlnr wth

hne-

modynamic changes and decrr;, .o of haematocrit!,

m pa-

tients without actively bleeding varices or, admsrmn. Patients with suspected esophageal

[XI)

vartces (past htstory

and physical signs) and in need of urgent treatment massive bleeding were initially

included

for

until confirmed

The following

criteria

(a) Anatamicai

for excli!sion

defects preventing

tube.

(b) Patient

balloon tamponade. ment bsd wen (e) Delayed

bleeding.

lowing standxd

t~%wwn:

easy insertion

Volume repl;tcement wtrh m-

travenous fluda ;md blood to mainram hwmarocnr 30%.

Ranmdmc

50 mg I.“. xere

and urine were determined

every 12 h. and following

serious bleeding episode. A cbesr X-ray

achieved. (ii) Continued

was

gastric

any

was performed

on admrsaon and at the end of treatment.

bleeding after 4 h treatment.

(iii) Massive bleeding within the first 4 h of treatment. (iv) Rebleeding h of treatment,

after initial baemusrasia and more than 4 but before sclerotherapy

(v) Complications

of either somatostafin

ponade requiring the discontinuation (vi) Elective sclerotherapy

was performed. or balloon

tam-

of treatment.

session the mornmg after ad-

lnrriol homostasia.

When a clear or ground-coffee

tric aspirate ww: obtained, namically stable

Rebkding.

Bloody gastric aspirate or frequent melae-

mission, provided haemostasie was achieved within 4 h of

nas with haemodynamic

treatment.

tocrit, after initial haemostasia.

(vii) At?er 24 h of baemostasm.

if for any reason. sclero-

End points vi and vii were required before amidering failure and alternal~vc

therapy was considered if any of the end points

reached.

Prirmry

changes and decrearer of haema-

haernosmsia. lni.ial haemostasia achieved and

lack of rc .,pses.

therapy was not performed. the treatment a success. T;eatment

gas-

and :he patient was haemody-

i 10vwere

Mowve

hleedmg.

Haemodynamic

stability

was not

achteved at d&nission or more than IDo0 ml,\ of i.v fluids was needed fc: If to be maintained. .%lurmodynon,ic aobili~,.

The presence of at, of the ‘ot-

towmp: (i) systolic hloud pressure over 100 mmHg: tart

rate less t:un

It,0 be;its per min: (iii)

over 35 ml/h: ;nnd (IV) too prripheral

(ii)

urine output

signs of low pcrfu-

siw

A protocol physws,

wth

xi

exzmunodon

(111). ulrrasout,d

dvta regarding (X).

post iwory

e!adoscopy (3).

(3). trc~tment

lmd

blood ~CF~S

(IO) and follow up(ltJ)

al-

lowed us to compere the two groups and the results

of

treatment.

The

efficacy uf ‘he two treatments

comparing the pro;> xtion

of patients with

number

was assessed by

of inittal hacmostasia achieved. successtul treatment

and compli-

cations.

for both groups are shown in Table 1. Fifteen chtded xc, nding to criteria ii reblrd within dosrrqy

(mean = 22 h, rhw:

= ; -53 h). Tuo

The sne of the sampb: was calculated by considering an somatortatin

to bc 25% less effective than balloon tampo-

nade (sensitivity

level of 0.21)

and. finatly,

I error) and 0.2

values of 0.05 to o (type

by giving

to fi (t!.pe II er-

ror). We planned. however. to review the sample size af-

I year. During

ter

this period of time the stud!! would be

?

of these patients un-

derwent

spy

.ession.

an elective scterothr

Chi-square

test with

Yates’

was used for discrete variables

correctton

for cc”. nuity

and Wilcoxon’s

test for

Confidence intervals

(Cl) for sample proportions

taken from tables of exac. confldencc limits dartribution

diffewxe

(11).

Ninety-two

Re

(Cl)

adn.r!e< On

to our Unit

a&n ssicn.

were randomly

bccause

bleedi-g

had

the criteria

fat inclu-

allocated to group A

(Somatostatin)

sod 22 to group B (Baliooz in grwp

tamparade).

A zad two In gro,,p Y %?)c! P ‘1x.

eluded from rhe final analysis, because of mzthodologicat (three

cases),

nasal lesions

rube insertion

which

comp:icawd

(one case) and simultaneous

bleeding from an undiagnored pc:!ic ~!ser (cze case). As a consequrncc.

portal

hyperten-

past history

of

on admission

and vaticed

bleeding

levels, prothrombin

and

time, incidence of encepha-

lopathy or ascites were found (Table 3). Within

the first

4 h 30 somatostatin

14 patients in group

(meat

f

S.D.

4 attained initial

=

hae-

2

Clinical dataof patients txae(! wth WF ntostatin ad balloon tamponadc

ThrPr

Sesgvaken

namic parameters

for

diseases,

haematocrit and haemody-

stigmata (Table 2). No differences in serum albumin

TABLE

remaining 44 patients fulfilled

errors

or surgery

for

itapped in 48, with ti,~ re’a?se in h Ispital.

“1Tientr

sclerotherapy

incidence of associated

bleeding. etiology of cirrhosis,

were cslcutated with the correc-

patients u’.,L

ston. Twenty-two

were found between groups

were

(12).

of varicea, haemorrhage. sp.mtanrously

differences

the re.

ww cur &red.

for p in a bi-

Confbdcnce ip ewals

of proportions

lion for continuit:

previous sion,

2.74 C 0.93)

continuous variables.

nomial

No significant

For

A and B with respect to age, sex, zctive alcohol intake,

bilirubin

considered as a pilot study.

patienb

rrbted 5 and 7 days afterlyarls. maining. only medical treatment

86% success rote for balloon tamponade (1). estimating

patients t.1.

53 h after en

IS and 20 cases were finally

for analysis in groups A and II, respectively.

considered

Entry

criteria

mostasia.

Th,ze

terwards.

The

79.7%)

II

either maintained

(six patients) tients)

of them rebled remaining

or until

5.5.

(SW,

7.5 and II

95%

haemostasia

morning.

=

k af33 5 to

session (fw!

Hscrvostasia

pa-

was main-

; 1.The

group B (27 f

difference between ,he two groups

IS no, ilgnlflc I”, Overall

‘rw more than 24 h

a sclerotherapy

the following

Cl

fx

mor!ali,y

while m the hospnl

groups A and B, respectwely

was 26 and 25%,

(five par!enr~ m each

group).

tained in the latter five patienrs for a mean time of 16 4 h. The three (ratients who rebled following

initial haemata-

sia. and the five pntients with persisten, bleedmg despite aomamstatin

in.u,ion,

were

stable and early aclerotherapy

kept

was therr performed.

of these patients had an rm:rgencv for severe persistent bleedi1.g

bleeding

B the balloon

10 patients

(50%.

haemostasia was maintained

the different therapeutic

rate of bleeding

vericeal

:P I2 pltientr Cl

(60%)

,CI. For the

= 27.2 to 72.8%)

for more than W ,I (eight pa-

acute

being considered

bleeding

and

01 cases with

a low morbidity

Sclerotherapy

mjeclions

has led 10 a r@ficant

who developed

ballwn

II

: fai:urc

Ikeding),

remainin,,

(eight for perrirten I?, variccal

-Gents

them died 3 days M No statistically

refueo

.frc:n

sigr ‘km,

of the

‘he treatrwnt.

massiv

4). The difference

The

One

of

were found

hehar-

during

actwe

would bc

proportions

the pa-

would have to

In thr case the number of wccc>)-

1;,ngroup

A (57.8%)

bleeding.

bleedkg.

run be erpecred.

However.

smce experi-

:ahigher

Comcquertly.

times this proccdurc is delayed until haemostasi

Somatostatm controlling

and vasoactiw

rate

some-

Ihas been

of irratmrnt

drugs are both s’fective in

acole bleeding. Although

(l-8).

and 1” m

they BT E god alfer-

of bleuJin$. following

z i@-50%

dixontinuatmn

strongly suggesting that they should

only he used temporarily. in tllis study. initial harmostaaia

tient in group B with a nas;., orifice lesiw

xlerotherapy

cnced ai,doscop.: ts are nor always availah,.

::,we”.~

somatostarin infusion, with a 95% Cl rzoging from -2X ,n

f,,, treat,,,en,s

Eodoacopic

relapse rate has been reported

in each group was 7.8% favourmg

be considered a failure.

(15-W).

of the survival rd,e has

decrease in emergency surgery for

natwes m the early nanagemcn,

to treat a:lalysis was performed

m 70-100%

frequency and

and for many !!roups I, IS the primary

prrformel

of complicn!!~ns

to stop

Endoscopic

and mortalily

ases or ,he comphca-

44%. If an intention

cxc

haemosrari.l

~rea,ment chmce for acute varice& when

(13-15).

,: attempt

lower rebleeding

(Lb-17).

,he mor-

Varices ranges

achrevcd by other mran!: (18-21).

haemorrhagc.

diffelmces

mostasia. rhe number of successful of successful treatment

bleeding and two sclerothcrapy.

arI”Lprqxt!ons of in&l

tween the two groups

tion rate (Table

portal hypci,mZon,

diagnovd

Eight of the ten oatients consadered

wdrrw

15

pn!!umoma.

did no, require dwantinuation

ramponade.

‘~CZ.~WI fc

aspiration

One pa-

n

ren

in some sludies aIt improvement been demonsrated

(rwo patients).

prevent

sclerothera ,y achieves primary

tients) or 3nlii an elective sclerothe, ?py sess!on was cu.

after sclerotherapy,

approaches.

ecophageal

+.;ly freimnen,

ried out 18 and 19 h afrerwards tient.

lrom

ng the study. strpped

95%

Drspm tality

fn .n 12 to J 1% in various prospective studir,

t.qwr&

within 4 h after inserrion

shunt

were no complica-

(2.6 k 0.82). Two patients rebled 8 aid 9 hi remaining

One

,nrtosystemic

Then

tions and none of the patients diw (!I In group

Discussion

hramodynamrcally

oon tamponads

was o.&ained

prmary

by ball-

in 60% of the patients. and primary ‘lae-

mosta~m m Xl?+. Some studies repon

the proport!on

haemostasia with balloon tampomde

(1 ,?A). although iccc concksivc

of

IS over 85%

rczult~ have albo been rc-

pot,co (2.22)

Smce the method used for halloon tompo-

nadc m this study ws (lJ.4).

stmilar

to that

in olher

groups

wc belicvc tluu the differences in results relate to

our dct .aitinn of successful treatment.

Our definition

re-

sclerotherapy. II error

is, however,

in success rate of 7.8%

quire\ miwd hnemostasi;~ within 4 h after the insertion of the Scngstnken tube. However,

-0.28

The probability

very high Q = 0.93).

usual 95% Ci (23.24). portions

in other studies. B maxi-

A difference

found in favour of somatostatin.

would

and 0.44. As B result, somatostatin

rates was not defined

effective. Gardner

tamponnde

quires careful assistance and is uncomfortable ticnt. ?lx (i-4).

complication

Aspiration

for the po-

rate is up to IO%, orwhird

pneumonia

is frequent,

refatal

while esophs-

value than the extreme two quarters - in fact

the middle half forms a 67% confidence cw!,

oon tamponade

(1.2.4).

In one pneumonia

patient

therapy

.rrsion.

from

our

balloon

was diagnosed

Since this complication

ported with both procedures,

it is difficult

cause. No other major complications five d~.lihs in the grout

tamponode

after the first sclerohas been reto establish the

were observed. The

were not related to balloon tam-

Somatostatm

has been shown more effective than pla-

cebo (9). and as effective as acute sclerotherapy vasopressin (7.R). with lower morbidity

(10) and

and fewer side et-

fects. In tiur study initinl haemostasis was obtained somatostatin

infusion in 74% of the patients,

with

and primary

the difference CI

= -13

to 19%).

quences of this calculated teracted

and a better

this Btudy was planned

lished conce..ning somatostatin

no reports had been pub-

the efficacy of balloon

versus supportive

prunary

haemostasia patients

small proportion

of patients.

systoles, diarrhoea) continuauon vourahly

in more than 70% of so-

(9.10).

No

major

minor

side effects (extra-

were observed (7). Somatostatin

due to side effects is rare.

with vasopressin,

complications

It compares

which is discontinued

in up to 25% of patients (6.7).

wmatastatin

complica-

were obsa ved in our study. In a

was administered

disfa-

due to

In our study

as previously reported (7).

Although

250 {tg of somatostatin

is usually given as an ini-

tial b&s.

when our studv was designed this dose was not I

I

yet widely accepted. thus 5Ogg were given instead. With a similar dose Kravetr

et al. (7) obtained

initial haemosta-

(blood

sions only) in acute variceal bleeding (22). had not been compared Two

randomized

to balloon

clinical

Lintan

(1.7).

Sona:ostatin

of 86%

(95%

Cl

achieved definite the study (95% calculated

=

One study assessed

with Sengstaken versus

haemostasia

according

to vase-

was found to have an efficacy

70-96%)

(1). in 53%

Cl = 34-72%)

would be required

either.

by the same

tube, and another compared somatostatin

pressin. Balloon tampanade

or

transfu-

tamponade

trials published

the efficacy of balloon tamponade

obtained

tamponsde

treatment

p,roup were quite informative

tions due to somatostatin

tolerance.

if hsemostasia is not achieved within 4 to 6

Kravetz et 81. (7) and Burroughs matostartn-treated

The clinical COIIK-

h. sornatostatin could he replaced by balloon tamponade.

hacmostasia in SK%. These results are similar to those of et al. (9). Jenkins et al.

In this and ball-

lower efficacy would he coun-

by fewer complications

Furthermore,

interval.

in efficacy of somatastatin

would not be more than 13% in favour of

the latter (67%

When

panade.

or 44% more

(25) state that ‘the middle

half of the confidence interval is more likely to contain the population

geal rupture and larynx occlusion have nlso been reported group,

and Altman

between

could he either

28% less effective than balloon tamponade,

Balloon

the

in the pro-

range

mum period prior to the appearance of clear gastric aspi(13.4).

Taking

the absolute difference

of successful treutment

was

of a type

and

somatostatin

of the patients

in

(7). Onr sample size was

to these figures

to complete

and 94 patients

the study. This figure is

very similar to the number of patients with variceal hleeding admitted

yearly in our unit. However,

we think this

sample size should be reconsidered

in relation

sults during

this period

the first year. During

number

of cases included

diKerent

than expected.

to our rebath

and the results obtained Should

the were

the results obtained

in

sm in 87% of his patients m a mean time of 2.3 I 0.2 h. By

this pilot phase be maintained,

increasing this mean time slightly more than two standard

would be needed to rule out a difference

dewarions.

20% type II error. Taking into account these data, we de-

3.5 h was defined as the upper time limit for

primary hxmostasia

with somatostatin.

If bleeding con-

tmued at this stage, hcwever, an additional somatostatin

was given. If haemosiasia

within 30 tin

following

this second bolus treatment

discontinued and conridered were allowed for somatostatin as the patient

to prove successful, as long

could be maintained

tive than balloon tamponada

was

non effective. Thus, up to 4 h

stable. In our study snmatostatm and achirving

50~1g bolus of

:VBSnot achieved

haemodynamicaliy

did not prove less effec-

m stopping vaGccal bleeding

haemostaria long enough to allow elective

several hundred

patients

with less than

cided to stop the study. since the period of time necessary to complete it would be too long for our unit. From the literature

(7-9)

and the present study it can

be concluded that somatostatin management

is an effective drug for the

of variceal bleeding.

able to acute sclerotherapy

Its efficacy is compar-

and vasopressin, and appears

to he similar to balloon tamponade.

In aodition,

it is safer

and entails a lower risk of side effects and complications than balloon

tamponadc.

Thus,

although

are necessary. we believe that if immediate

larger studies sclerotherapy

SOM*T0ST*TIN

YS.

BnLLOOPi

can not be performed. ferred, somatostatm

TAMPONADE

O, i, rhe pien,

rREA*MtNr

must be trans-

105 *ck”owledgeme”t

can be considered as it pnmary treat-

ment choice for cases of acu,r va,iceal bleeding. The main disadvantage at somatostalin

is its high cost. a debatable

problem when Ihe risks of sevr,r tient comfort are considered

complications

and pa-

We ackwwlcdge rhagr iinit

the nursmg buff

for their invaluahh

help

of the D,

Hacmor-