CLIN ICAL GASTROENTEROLOGY

Endoscopic injection therapy in bleeding peptic ulcers. Low

mortality in a high risk population

j l)A()UIM BALANi'l\ MD, CANrnn V ILLANUEV.i\, Ml\ jORt,E C ESPINt)S, ML\

SER<~IO SA IN?, M l), GERMAN SORIANl\ MD, DOLORS Gl)NZALEZ, MD. XAVIER RI US, MD.

Jt)Rt;E Plllt, I..'\ C ,\LLF, MD, FACS, FR1\NCl~Ct) VILi\RnELL, MD, FRCP, FACP

J BALANZ6, C VILLANUEVA, JC ESPIN6S, c t al. Endoscopic injection therapy in bleeding peptic ulcers. Lo w mortality in a high risk population. C an J Gastroen terol 1992;6(5 ):265-268. EnJoscoric injectio n the rapy was per­formeJ in 341 patients consccu ri vc ly admitteJ wirh a b leeding peptic ulce r a t high risk of further he morrhage, assessed by che presence o f active arteria l hlccd ing o r a nonblecJing v isihlc vessel a t emergency endoscopy. In it ia l hc mo­stasis was achicvcJ in 11 L of 119 actively bleeding pat ie nts (93%). Reblceding llCCurrcd in 75 cases (23%), at a mean interval of 53±52 h. A ~ccond emergency injectilm was a ttempted in 36 the rapeutic fa ilure~, anJ wa~ successful in 20 (55%). Emergency surgery wa~ fina lly req u ired in 52 patien ts ( 15%). Overa ll mortality was 4.9%. Majo r complicaLio ns occurred in four patients ( 1.2%) (two perforat io ns a nd two aspiratio n pneumo nia); therefore, injection therapy is an effecti ve anJ ~imple methoJ for trea t ing bleeding ulcers, achieving the initia l control of hemorrhage in a majori ty of cases altho ugh t he rate of fu rt he r hemorrhage is not negligible and com plicat io ns arc nnt irrelevant.

Key Words: Bleeding pe/nic ulcer, Injection therapy, T hera/>eucic enduscupy

Traitement d'ulceres gastro~duodenaux hemorragiques au moyen d'une injection administree par voie endoscopique. Faible taux de mortalite clans une population a risque eleve

RESUME: U n mi itcmcnt en injec tion par voic cndoscopique a etc administrc a 34 J patients consccut if~ aJmis po ur u lccre gastro-duoJ cnal actif e t a risquc elcvc a l'cgard <l'hcmorragies subseq uences, tel qu'a ttestc par la p resence <J'unc hcmorragie a rtcric lle acti ve o u non a l'em loscopic d'urgence. Unc hemosrnse initiale a ere obtenue ch ez l l l des J l 9 pat ients e n hcmo rragie active (93 %). Le smgnement est reapparu dans 75 cas (23 %), avec un interva l le de te mps moyen

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Conl'S/)()lldence w1J rc[lri111,: Dr ./om11iim n11h111~,i. Ser11ei Je J>awlol{ia fJi,zesuve. l-los/1iwl de "' S,111U1 Cret1 1 Sant 1'1111, Av,1;clti.Sanr Anwni M ·' Clam, I 67. 08025. Barcelrma, SJ1ain. Tckplwne 34 93 236 47 21, F,n 34 3 456 0 I 60

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BLELl)JNt; PEPTll' Ul.l'l:R Rl:;,.{AINS A

rele\'ant health problem with ~ig­nifknnt nwrh1di 1y and morrnli 1y des­

pite the intr,iduction of d iagnostic enduscnpy, impn1"ement, in technnl­ugy tor resuscitarion nf hlceding patients ,rnd in medicnl management ot ulcers wirh pharmawlogical agents ( l ). Howcver, diugnnslic endo,uipy has as­sumed an imporumt rok due tn its ac­

cu rncy in detccu ng 1hc hlceding ks i1111, and in dcfining ,t igmata of rccent hemnrrh,1ge ll'h1ch nre \·aluahle prog­nosnc ind1ca1or, of the risk of an un­fo\'\lrahle outCtHne (2). Furthermore, from the rc,ul b 111 thc Clin1rolled

stud ies rep,irtcd to date ( 1.4) and the conclusiom uf Lhc Consen,u, Con­ference at the USA National Institute · of Health (N IH) (5), therapeutic endo­

scopy can he regarded as the fir L hemo­static procedure in patients with ulcer, ,1t high risk of funhcr bleeding.

A recent meta-analysis abo showed that thernpcuc ic endoscopy reduces

rcb lceding and requi rcmcnr for emer­gency surgery hy nearly Lwo-th irds and

morta lity by nearl y o ne-third ( 4 ). Patie n ts with c linical evidence of a

major hemorrhage and active arterial b leedi ng or a nonhlecdingvi~ihle vessel at endoscopy should he t reated ( 5 ). Thi.:

N IL-I Cnnsen,us Conference Ji.:ter-

265

R.·\l.,\Nll'l t'I ll l

de 53±52 h eurcs. U n e dc ux ic mc injectio n d'urgcnce a e tc administ rec J uns 36 des cas ou la m anoeuvre a ech o ue er a rcussi ch cz 20 d'entre cux (55 %). U n c c hirurgie cl'urgen ce a fina le ment ere necessa ire dam 52 cas (1 5 %). Le taux d e morta lite globa le a e te de 4,9 %. De graves complica t io ns se sont produ ites ch ez 4 patien ts ( 1,2 %). (ll s'agissa it de deux cas de pe rforation c t de deux cas d e pn eumo n ic pa r inh ala tio n . ) On peut don e conclurc q ue le t raitement par injec tion est une methode efficace c t simple de traiter lcs ulcc res acrifs pour parvenir a mat'rriser rapid em cnt l'hcmo rragic clans la majo ri te J es cas, bicn q uc le taux de recurren ce d e I 'h emorragie c t des comp lications n e so it pas n cgligcablc.

min e,( th :it mulL ipolm e lcc trncoagula­

tion and h eat probe were the most prn­

m i, in g tech niq ue s and th aL injection

therapy wammt ed further study. In th e

past few years se vera l prospective and com rolled rri,, ls ha ve ~hmvn the effi­

cacy of injec tion therapy (6- 12 ), irs

simp lic ity, safel y nnd low cost ,1re great

advan rnge, . C ompa rnt ive st ud ies h ,we

a lso sh own th a t its efficacy seems to he

equa l tn th at o f thenm1 l methmb such

as YAC laser ( 12 ) or mulripo lar clcc­

t rncoagu lation ( 13 ), while s imi lar m

inferior resul t~ have hcen ac hieved

compared wi th he at prohc~ ( 14, l 5 ).

The prc~elll report descr ibe~ the

re~Lil ts achie ved with injec t ion thernpy

in a large se ries of ra t icn ts ad mi u ed

consecuti ve ly with a h leed ing peptic

ulcer at h igh ris k of furt he r h emor­

rhage, assessed hy th e prese nce nf ac tive

arte rial hlced ing, o r a nnnhleed ing

v i, ihle vesse l. s ~m1e technical varia­

tio ns suc h as the use of a second emer­

gen cy injec tio n in the ma nagement of

thernpcutic fai lures were a lsn evaluated.

PAT IENTS AND METHODS During a 4 2-mon th period ( 19ti7-

9 J) , 1880 p,ltien ts were adm in ed to the

a utho rs' h ospital hecause n( co n fi rmed

upper gastroimestina l hemmrhagc.

Emergency endoscopy was pe rlnrmed

in all within 4 h of adm ission, afte r

resusc itatio n me;1s11res ,ind lavage hy

rnisogast ric tuhe. Endoscopy d isc losed

34 1 patien ts with gastr,,duodenal ul ­

cers a nd ac tive a rterial bleed ing nr ,1

non hleed ing l'is i hie vessel. J njecrinn

th erapy was pe rformed in a ll uf t hese

p,n ien ts. No pa Li ent wa, cxcl 11, led be­

c;1usc uf technic.:;1 [ prnhlem:,, the

se verity of b leeding or t he locm ion ot

the ulce r. No oth er selection c rite ri a

were used .

Em ergency endoscnpy \\':l~ perfor­

med using a n O lympus !T IO nr IT20

fih rescope. V igomus washing of the

u lce r floor 11·as carri ed nut when re­

qu ired to remove c luts and de hri s. A drl•n a li nc injec tio n was pe rfo rmed

with a Micn>vas ive l 123 need le {Mas­

sachusetts ), during the same emergency

p rocedure. Snme patients were a lso in­

c luded in twn cnn t rn lled t riab to

evaluat e whe ther addi Lion o( rh n lmhin

( 16 ) or 1% pnlidornn n l (1 7 ) cou ld im­

pruve th e results achie ved wit h ad ren ­.1li ne ,done. Adrerd ine ( l / 10,000) was

injec ted in a liquots n f l .0 to 2.0 ml firsl

a round and t he n in to th e visible vessel

m (Wer and a round rhe bleeding a rcn,

up to a w t al of IO LO 15 ml. A fte r

therapeu tic e ndoscopy, nil pat ien ts

were admi t ted to t he gastrointest inal

hlecding unit.

W h enever r oss ih lc a second clec­

ti \'e endoscn py was performed be tween

the second and the t hird day after th e

emergency procedure. W he n a , ·isihlc

vessel was identifi ed a t the time ,if t h b

e lect ive endnscopy, ,, Sl'Cond injec t i( l!l

was carried o ut by the sam e meth od as descri bed ahove.

Pe rmanen t h em nstas is was d efined

.1s cessatio n o f b leeding ( initia l h emo­stasis ) and absence of recurrence du ring

lh )spi La lizatio n. T rea l me nc was con ­

s ide red a failure if th e re were s igns of further bleed ing afLer t he emergen cy

injec tion treatmen t. Furth e r bleeding

was defin eJ as one of the fo llowing:

act h'C bleeding m repe:n ed endo,copy;

vomit ing of fresh h lood or bloody

nsp irn te., a fter pre\' icius cle,, r la"ages hy

nasogast ri c t uhe; u r th e passage of fresh

melena , p lus: hernodyn am ic and c lini ­

ca l e\' iden ce ofhypovll lemia; lll' a fo ll of

h l'llHlgl,lhin requiring transfusion. Rc­

pe,u cd endoscopy when the rapeuti c

fai lure occurred ll'as nrn mancla ted hv

the prow col and \\'ils only pe rfllrmed Ill c ase nf do u ht.

' S tuden t \ r test and th e x.- test with the Y,1tcs' correc tio n when necessary.

were used for swtisti cal ,u1alysis.

P<0.0 5 was conside red stmht ically sig­nifican t. Cont in uo us , ·m iah b , were ex­

pressed as mean ± one standard dc,·iation.

RESULTS Ot the 14 l patients included , 1 h ere

were 230 males and l I l fema les, wi1 h a

mean age of 64.9± 15 years. T he luca­tio n of Lhe ulce r wm, gastri c in I l O casl's

(12.3%). duodenal in 198 (58 "o).

pyloric in 16 ( 4. 7% ) nnd ~wm al in l 7 ( 5'\, ). A ct ivc sp urt mg h leed mg was d is· c losed in 12 patients (3 .5% ), Oll: ing 111

107 (3 l .41}h ) and a no n hlccd m g \'isihlc

\'esse l in th e rem aini ng 222 (65. I 'X,). In I 3 7 pat ien ts there 11·,is ,1ssoci ,1ted

l h rnnic di-.ease (40.2°h). In itial hemostasis w,is .1chie \'cd 111

Ill of the 119 pa tients wit h ,K th-e

b leed in g (93%) . Only in twu pa tien ts

was injec t io n therapy impossihle due rn o ngoing h emorrhage with hemu­

dyr\ilm 1c imt ahi Ii t y 111 ho t!, cases.

Emergency surgery was perfn rmed in six

l ) f c ighr pa t ien ts with pe rsistent h leed­

ing, and definiti ve hemosrnsis wa,

achieved. The re m;1 ining two patient,

d ied withou t furrh e r h emnstmic treat ­m ent.

Rehleed ing occurred in 75 nf rhl·

33 3 patie nt~ in whnm the hemnrrha.~e had heen cont rn lled initia ll y (22%) at

a mean of 5 3±52 h. In 10 of thesl'

pat ient s emergen cy surge ry was per­

form ed (o n e dea th ). In 36 rehleeders a second endoscopic m jection wa, ,ll · tempted and was ~uccessfu l in 20 cases

(55%), hut e me rgency surger~ was re­

qu ired in 15 (one J emh) . A nother

r a ti en l d ied withm n surge ry a ft e r the

fai lu re of the second emergency in jec­

tion . In rhe remrnning nine rehlceJcrs

no furth e r tre.itment was attempted,

due LO the gravity o f a~soc iated d iseases.

Re hleed ing was se l(- limi tcd in tw11 .ind

the ,it he r seven d ied .

Four ma jo r cum pl icaw ins resu I red

fmm the injec tion tech niq ue { l .2'\1), rwo pe rfor,1110 11, (,m e dent!, after

surgc rv) and t \\'11 asp ira tio n pnc urnoni,1

(o ne dc.irh ). N,, :td \'l· r,e systl' llliL l'f .

266 C:\N J t ~ .. \ ~TRl WNTFR, )[ V( )[ 6 N, l 'i SFl'n:-.tl\l· R/l )c Tl 1111 R J 992

TABLE l Global results of endoscopic injec­tion therapy in 341 patients

Results Initial hemostasis

Rebleeding Emergency surgery Major complications Mortality

Number(%)

333 (97%)

75/333 (22%) 52 (15%) 4 (1.2%) 17 (4.9%)

'Transfusion (mean ± SD) 2.7-t2.7 Hospital stay (days.

mean± SD) 10.9±9.9

'Units of pocked red cells

tects in re latio n to the injected agent~

were observed. Emergency surgery was requ ired in

52 patients ( 15%), in 51 hecause of uncontrolled hemorrhage and in one due ma complication of t he technique.

Injection therapy was successful in 2 58

l'atients after one emergency injection {75 .6%) while permanent hemosrasis

wa, fina lly achieved in 278 cases (81.5%). Transfusinnal requ in.:ment~ were 2.7±2.7 un its nf packed red h lood cells and the du rnrion o( the hospiw l scay was l0.9±9.9 days (Tahle l ).

Overall morta lit y wa~ 17 patients (4.9%) due to the hemorrhage or re ­

lated to procedurnl complicat1om in 12 cases (3.5%). The remain ing five p.:1-nenrs died from associated diseases after

Jefinitive control of t he hemorrhage. Re ults were also evaluated acc11rd­

ing co the stigmata 1l hemorrhage ob­

served at the time of the in it ia l emer­gency endoscopy (T,1hle 2). Pmient~

with a non bleeding visible vesse l had a tendency towards lower rates of therapeutic fai lure, fewer nct:d~ for

emergency surgery, luwcr trnnsfusinnal requiremenrs and ,1 shorter lengrh nf hospital stay alt hough nnne u( the rrends reached ~tatistical significance.

The result~ were alsu analyzed ac­

cording to the locmion of the ulcer in regard to large vcsseb. T h erapeutic lailures were signifirnntly more cnm­

mon in ulce rs !neared in the poste rior wall of the d uoJ cna I hu I h ( 24 of 48,

50%) than in those at other sites (P<0.05). Therapeutic fo ilu res were nn more frequent in ulcers located at the inferior wall of rhe bulh (zero o( I 0) m

!ugh in the lesser gastric curvat urc ( fi vc

of 19, 26%).

Endoscopic injection in bleeding ulcers

TABLE 2 Results of endoscopic injection therapy in 341 patients according to the stigmata of hemorrhage disclosed at admission

Active bleeding Nonbleeding visible Results (n=l 19) vessel (n=222) Therapeutic failure 35 (29%) 48 (220,.i,)

Emergency surgery 23 (19%) 30(14%) ' Transfusion (mean ± SD) 3.1±3.4 2.5±2.4 Hospital stay (days, mean ± SD) 11.1±9.9 10.7±9.8 Mortality 7 (5%) 10 (5%) Time of rebleeding (h. mean ± SD) 64.9±61.7 44 1±53. l

'Units of pocked red cells. No significant differences between two groups

DISCUSSION Further hemorrhage is the single

most important prognostic focrnr for pau ents with ,1 hlecJmg ulcer ( 18). The presence of act ive arteria l bleeding at

emergency endoscopy b associarcd

with furrhcr hetnllrrhngc in 85% of cases (2), while a nonhlceding vbihlc

vessel on the u lcer floor results 111 a reblecding rate of 35 to 551X, (2). Stig­mata of bleed ing also prm·ide a target to

which endoscopic therapy must he ad­dressed rn oblireratc the underlying arte ry ( l 9,20). In the p resent study, all pnrients in whom emergency cnLlo­

scopy disc losed srigmma of hemorrhage rece ived injec t ion therapy. The proce­dure could he performed in a ll hut two o( the 341 cases (0.6%) because of ex­

sanguinaring hemnrrhage. Initial hemosrasis was achieved in 93'Xi of cases and permanent hc1m1stasis in 81. 5%, while emergency surgery was re­quired in J 51X, , with an ovcrn ll mor­

tality of only 5%. A previous cnntro llcd trd had

simibr rates of efficacy u,ing inject inn

t herapy in a selected high risk popul.1 -1 inn (6) . The results ach ieved in orlwr

controlled trials c,·n luat ing injectHm thcrnpy have hccn simi lar (7- 12) and have been confi rmed by a recent mew­ana lysis (4). Huwe\'cr, in on ly one of Lhe~e tria ls was morta l ity s ignificrntly improved (9).

T here were four severe comp I ica­t inns ( 1.2%) in the present study, with

t wo deaths, indicaLing that despite the safe1-y of the tech nique the rate of cnm­plicariom is nrn irrelevant. T h u~, a~

suggested by the N l H C o nsensus Con­fe rence (5), cnrrect ind ication, careful performance n( injections and close

monitoring of patients arc mandatory to improve safct y.

The present results indicated that there was a tendency w11·nrds hcttcr results in patienb injected with a non­

hleed ing visible vessel cnmparcd with patients with act ive arteria l hlecding. although the trend d id nm ach ieve statistical significance. ln keeping wllh

nther .iutl·wrs (2 1-23 ). therapeutiL fa ilure 11·as signifirnnrly more frequent in pa1 1cni,, with ulcers at the poslcri,ir

wall o( Lhc duodenal hu lh, clnse to rhc

gasrrndundena I artery. As in previous controlled trials (6-

J 0), the init ial contrul nf hemmrhauc w,b achieved 111 more than 90% o( ac­tive bleeders, ~uggcsung that mmt n(

the tinw surgery could he performed ,in

hcmndynamically ,rnhk· patients. The mu1 inc use of a second endo­

scopic rrcmmcnt in the presence nf foilurc must he considered with caur inn

as it cnuld incre,1se the mortality by ,lc l:1ying surgery. In the present study ,urgcry was perf1 mned ,1, soon w, evidence nf rcbleeding was elicited. only when a major surgical contrai ndi ­

c.H inn was present, a second endo­scopic treaunent wm, performed. Th is happened in 36 patients and bleeding

was cnnrrnlled in 22 (53.6%) while the remaining required surgery. With this approach there was a very low total

morrnlity ( 17 pat ient~. 4.9%); in on ly 12 cases was death related to the hemorrhage or w complications of treatment (3.5%) .

Few comparative studies have heen

pe,formed to evaluate the mo~t suirnhlc solut ion for injection therapy. In pre­viou~ control led t rinb, the prc~ent

a uthor~ as~c~sed the efficacy nf

267

BALAN7t'I i!C al

adre naline alone Llr comhined with either thrombin ( 15) or I% polido­

canol ( 16). Combined injections did not imprnvc outcome.

Present results indicate that cndo­,cnpic injection of adrenaline is a simple and effective fir,r therapeutic approach fnr bleeding peptic ulcers at risk of further hemorrhage. Major com­

plicarions, although rnrc, arc nnt ir-

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7. Pani:.,J. Vl\·erJ, F\lm<: M, Uarrn1-Oli,·;irL':- E, Man.:n C, Carnu J. CPmmlled t nal nf endoscopic ,clcrllsi, in hleeding pcpuc ulcer,. Lancet 1987;1i:1292+

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268

rdcvant. With endoscopic injection, initial hemosrasis can be achieved inn majority of cases. However, the in­

cide nce of further hemorrhage i, not negligible, as with any ocher method of 1 hcrnpcutic endn~c,lpy. The prc~ent study shows thar rcbk:ed ing occur, early (at a mean time of 53 h). Further

randomi:cd and controlled triab arc re­quired to evaluate whether pcrfor-

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I 1. Laine L. Mult ipolnr clectrncoagulminn vcrsu, 111jcc1 i()n therapy in the t rcat mcnt of hked i ng papric ulcer,. A pnispecnve n111dnm1:ed trial. U.1:-1 rncntcrnlngy I 990;99: I 30'l-6.

14. Lin I-IL. T;;ai YT. Lee SL), ct ,11. A pn,,pccuve rand,lmi:cd trial of hem pmhe thcrmncnagulanon versus pure alcolwl mjl'ctilH1 in nunvnrice:il peptic ulcer hem,irrhage. Am J Gast roenterol 1989;8 3:28 3-6.

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mance nf a second early elective treat­

ment after the initial con trol nfhcmor­rhagc hy injection could improve results by avllid ing rcbleeding (16,24,25). The present authors ,1dvise

surgery in the prc~encc llf therapeutic fa il ure, except when there ,ire major contraindic,1tions. With this approach they achieved a very low morrality rare (4.9%).

u,mg epinephrine v, cpincphn nl' ,ind actuxi,clcrol. Pre,ented ,it the WorlJ Cmgrc,, ul (. ~,1,1 roe men ,logy, I 990.

18. l)c Domhal Ff, Clarke JR, Clamp SE, tvh1lt:i,1 G, Kotwnl MR. Mnrg,111 AG. Pmgnn,ric fac11 ,r, m upper Ci I hleeding. End,1,cnpy 1986; 18(Suppl 2);18:6-10.

19. Swam er, Swre~ DW, Bown SC, ct nl. N ,11ure llf' the hlccd1ng ,·c,,el 111

recurrently hlccdmg gastric ulcers. (~;iwocmemlogy I 986;90:'i95-608.

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