Digestive Dias and Sciences,Vol.50,No.2(February2005),pp.394–398(C 2005)
DOI:10.1007/s10620-005-1617-x
U of the Six-Shooter Ligation Device in the Management of Bleeding Esophageal Varices:
A Developing-Country Experience
W.M.EL-SAIFY,FRCSI,FRCS,MSc,and F.A.MOURAD,MD
Endoscopic variceal ligation has emerged as a superior alternative to endoscopic injection
sclerotherapy,however,the“single-shot”mechanism of the generally ud Stiegman–Goff liga-
tor made the procedure tedious and time-consuming and required overtube placement,associated
with discomfort and potentially life-threatening complications.In this study we describe our experi-
ence with the Saeed Six-Shooter(multiple-ligation device).Fifty concutive patients with variceal
bleeding were prospectively studied.After initial endoscopic ligation,subquent ssions were every
2weeks.Study outcomes were:the ability to control active bleeding,the frequencies of rebleeding,
the number of treatment ssions and time required for irradication,the percentage eradication of
varices,complications,and mortality.Active bleeding was controlled in all eight(100%)patients.
Four(8%)patients rebled,three from esophageal varices,and one from portal hypertensive gastropa-
thy.Esophageal varices were eradicated in47(94%)patients(3.1±1.3ssions).Time needed till
eradication was6.2±1.9weeks.Chest pain was reported in two(4%),low,grade pyrexia in two
(4%),and pneumonia in one(2%)patient.There were three deaths,none due to exsanguination.The
对联福字Six-Shooter is a safe and efficient device for the endoscopic ligation of esophageal varices which has
overcome the limitations of the single-shot ligator:(1)Visualization is better(the endoscopic“tunnel
vision”and internal light reflection from the stainless-steel banding cylinder of the single-shot device
are avoided);and(2)the u of an overtube is no longer necessary and rious complications can be
avoided.
KEY WORDS:esophageal varices;portal hypertension;variceal bleeding;endoscopic variceal ligation;Six-Shooter.
Endoscopic variceal ligation(EVL)was introduced in 1986by Stiegmann et al.Inspired by the technique band ligation for hemorrhoids,EVL consists of ensnar-ing esophageal varices with elastic bands.The varix is first aspirated into a hollow cylinder attached to the tip of the endoscope.An elastic band,mounted on the distal end of the cylinder,is then relead over the varix by pulling on a trip wire that runs through the working channel of Manuscript received May12,2004;accepted August6,2004.
From the Department of General Surgery,Assiut University Hospitals, Assiut,Egypt.
Address for reprint requests:Dr.W.M.El-Saify,Department of General Surgery,Assiut University Hospitals,Assiut,Egypt; the endoscope.The strangulated varix thrombosis and the tissue slough over3–5days,leaving a shallow ulcer that heals over the cour of2–3weeks.The endoscopic lig-ating device(ELD)is constructed of stainless steel and consists of four parts(the housing and banding cylinders, a loading device,and the stainless-steel trip wire)(1).
A technical shortcoming of the single-shot mechanism; whereby only one ligation may be applied per endoscope inrtion;is that it requires removal,reloading,and rein-rtion of the endoscope for each varix ligation,which makes the placement of an overtube—associated with dis-comfort and potentially life-threatening complications—prior to EVL practically mandatory(2–4).Reloading pro-longs the procedure,which may be critical in the actively
好词积累394Digestive Dias and Sciences,Vol.50,No.2(February2005)
0163-2116/05/0200-0394/0C 2005Springer Science+Business Media,Inc.
T H E S IX-S H O O T E R L IG A T IO N D E V IC E F O R E S O P H A G E A L V A R IC E S
bleeding or uncooperative patient(2).Endoscopicfield of vision is decread approximately30%when using the ELD owing to the outer cylinder attachment at the tip of the endoscope The cylinder also has the disadvantage that internal light reflection occurs if the trip wire connection is positioned over the illuminationfiber(1).The above shortcomings of the ELD have fostered the development of new multiple-band ligation devices to make band lig-ation easier and more efficient,allowing the concutive application of5to10bands without removing the endo-scope.The prent study was undertaken to prospectively evaluate one of the devices regarding safety and efficacy.
PATIENTS AND METHODS
Patient Population.Fifty concutive patients referred for the treatment of active or recent hemorrhage from esophageal varices between September1997and October1998were in-cluded in the study if they met all the following criteria:(a)endo-scopically proved esophageal variceal bleeding,(b)no history of endoscopic or surgical treatment for varices,(c)abnce of hep-atocellular carcinoma,(d)no major systemic dia predictive of less than6months’survival,and(e)willingness to partici-pate in the study and informed connt given.Previous treatment with pharmacological or balloon tamponade before endoscopic treatment was also included.The verity of the liver dia was graded according to Pugh’s modification of the Child classifica-tion(5).Beppu’s classification was ud to grade the varices(6). Patients were not included if they had(i)hepatorenal syndrome, (ii)gastric varices,or(iii)other possible sources of upper GI tract ,peptic ulcer.Patients were excluded fromfi-nal analysis if they developed hepatoma or an other malignancy during the study period or were lost to follow-up.The study was approved by the Clinical Rearch Committee of our hospital.
Definitions.Acute variceal hemorrhage was defined as demonstration at emergency endoscopy of a spurting or ooz-ing varix,or an adherent clot on a varix,or esophageal varices and no other pathologi
cal conditions to explain upper GI tract bleeding.Control of active variceal bleeding was defined as ces-sation of bleeding for at least24hr after the emergency pro-cedure.Cessation of bleeding was confirmed by the abnce of fresh blood in hourly gastric aspirations during thefirst24 hr and by stability of vital signs(not more than a20mm Hg reduction in systolic pressure or>20-bpm increa in pul rate).Failure of primary hemostasis was defined as continued bleeding or a further episode of bleeding that occurred within or 24hr after thefirst ssion,persistent tachycardia(pul>100 bpm)and/or hypotension(systolic blood pressure<90mm Hg) for2concutive hr,and transfusion of more than4units of blood within6hr to maintain blood pressure.The patient under-went another endoscopic examination,if this confirmed further esophageal variceal bleeding,a cond ssion was performed. Rebleeding was defined as upper GI hemorrhage(hematemesis or melena)before variceal obliteration has occurred.All patients with rebleeding underwent endoscopic evaluation each time this occurred.The cau of rebleeding may be esophageal varices, treatment-induced ulcers,gastric varices,or portal hypertensive gastropathy(7).The bleeding was classified as indeterminate when the source could not be identified or endoscopy could
not Fig1.Grade III esophageal varices.Beppu’s classification was ud for grading.
be done due to hemodynamic instability.Time to obliteration of varices was taken from the beginning of the endoscopic ex-amination that revealed obliteration.Variceal eradication was defined as the prence only of vesls too small to treat.Com-plication was defined as each resulting event requiring treatment, supplementary therapy,or extension of the hospital stay.
The Device and Technique.The ELD and its operation have been described in detail by Saeed(8).Endoscopy was performed under topical oropharyngeal anesthesia and conscious dation with intravenous midazolam,using front-viewing Olympus en-doscopes(EVIS CLV U20).At each endoscopic examination the number,grading,and fundamental color of esophageal varices and the prence of red color signs,portal hypertensive gastropa-thy,or gastric varices were assd(Figure1).Ligation was con-fined to the lower5–6cm of the esophagus starting at the gastro-esophageal junction,ligatingfirst the most prominent varix or the bleeding varix in the ca of active bleeding(Figure2). Other varices were ligated quentially cephalad.The largest possible number of elastic bands was positioned in the distal esophagus.
Follow-up.Patients were followed up prospectively.Sub-quent ligation ssions were performed every15days un-til the varices were eradicated.Follow-up endoscopy was per-formed every3months for thefirst year and every6months thereafter.When rebleeding mandated unscheduled intervention,
emergency endoscopy was performed to determine the source of bleeding.Acute variceal rebleeding was treated as initially,while for nonvariceal hemorrhage,H2receptor antagonists,proton pump inhibitors,or somatostatin(if the source of
bleeding Fig2.Active variceal bleeding;ligation in progress.
Digestive Dias and Sciences,Vol.50,No.2(February2005)395
EL-SAIFY AND MOURAD
T ABLE1.D EMOGRAPHICS AND C HARACTERISTICS OF P ATIENTS
I NCLUDED IN THIS S TUDY(n=50)
Characteristic
Age(mean yr±SD)50.6±10.5
Sex(M/F)38/12
Etiology of liver dia
Liver cirrhosis35(70%)
Mixed cirrhosis and schistosomalfibrosis15(30%)
Child–Pugh class
A22(44%)
B18(36%)
C10(20%)
Physicalfindings
Liver
Enlarged12(24%)
Shrunken28(56%)
Not felt10(20%)
Spleen
Enlarged39(78%)
Not felt11(22%)
Ascites(−/+/++/+++)30/15/3/2儿童画蛋糕
Encephalopathy10(20%)
Portal vein diameter(mean mm±SD)14.6±1.8
Splenic vein diameter(mean mm±SD)11.4±0.6 was congestive gastropathy)was added.Patients who were considered treatment failures were offered alternative treatment independent of the protocol.
Statistical Analysis.The data are expresd as mean±SD.
RESULTS
The demographic profile,etiology and verity of liver dia,and clinical prentation of the study group are listed in Table1.Findings at the initial endoscopic exam-ination are reported in Table2.
Arrest of Active Variceal Bleeding.Eight of the50 (16%)patients prented with active variceal bleeding. Active bleeding was controlled in all eight(100%)of the patients(in two of eight patients a
cond ssion was performed to achieve primary hemostasis becau of a further episode of bleeding that occurred within24hr after thefirst ssion)(Table3and Figures3and4).
T ABLE2.E NDOSCOPIC F INDINGS AT P RESENTATION(n=50) Grade of esophageal varices
II32(64%)
III18(36%) Cherry red spots8(16%) Portal hypertensive gastropathy
Abnt13(26%)
I17(34%)
工程整改报告
II12(24%)
III8(16%) Activity of bleeding小演奏家
Spurting/oozing8(16%)
Adherent clots2(4%)
T ABLE3.R ESULTS(n=50)
Control of active bleeding8/8(100%)
Failure of primary hemostasis2(4%)
Rebleeding2(4%)
Variceal bleed1(2%)
Portal hypertensive gastropathy1(2%)
Variceal obliteration47(94%)
Number(mean±SD)of ssions
until obliteration 3.1±1.2
Time(weeks)for obliteration
(mean±SD) 6.2±1.9
Total number(mean±SD)of bands
For eradication24.4±1.2 Variceal Eradication.Varices were eradicated in47 of50(94%)patients.Eradication was achieved after3.1±1.2ssions(range,2–5),completed in6.2±1.9weeks (range,4–10weeks).The mean number of bands required for achieving obliteration was24.4±1.2.Varices were not eradicated in the remaining three patients due to death. Rebleeding.Rebleeding occurred in two(4%)pa-tients,on days4and6,respectively,after the most recent ligation ssion.Rebleeding was from esophageal varices in one patient;ligation was attempted and was successful. Portal hypertensive gastropathy was the cau of rebleed-ing in the other patient.
Visualization and Ea of U.Working without an overtube improved the insufflation and suction capability, due to a tighter al at the oropharynx.We did not en-counter any difficulties in intubating the esophagus with the endoscopefitted with the Six-Shooter.Visualization through the side walls of the transparent chamber was ex-cellent.After each successive band comes off the chamber, visualization improves progressively(Figures5and6),in contrast to the view with the opaque single-shot device “tunnel vision”en in our previous work(Figure7). Complications.None of the patients had any fatal complications.Retrosternal pain occurred in two(4%) patients but persisted for less than24hr.Two(4%)pa-tients had-low-grade pyrexia lasting for24–48hr after
the
Fig3.Failure of primary hemostasis.
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T H E S IX -S H O O T E R L IG A T IO N D E V IC E
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G E A L V A R IC E
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Fig 4.Control of active variceal bleeding.
procedure,and aspiration pneumonia was reported in one (2%)patient (Table 4).
Mortality.Three (6%)patients died during the follow-up period,none from exsanguination.The cau of death was liver failure in all three.Two patients who died were in Child class C,and one was in class B.
DISCUSSION
In our study,active bleeding was controlled in all eight (100%)patients who prented with active bleeding.In the study by Saeed (8)control of active bleeding was achieved in ven of ven (100%).Similar results were reported by Hou et al.(9),where success in arresting active variceal bleeding was 20of 20(100%).In the study by Lo et al.(10),active bleeding was controlled in 17of 18(94%).Gimson et al.(11)controlled active bleeding in 91%,while Lain et al.(12)succeeded in controlling active bleeding in 8of 9patients (89%).In a similar study Stiegman et al.(13)controlled active bleeding in 12patients (86%)of 14who prented with active bleeding.
In our study,control of active bleeding was de fined as hemostasis 24hr after the first endoscopic treatment with stable vital signs.The de finition of control of
active
Fig 5.Typical visualization quality during the ligation process;three filaments pass under the rubber
bands.
Fig 6.Typical visualization quality after all bands have been relead.
bleeding varied to some extent in the other trials.Stieg-mann et al.(13)de fined control of active bleeding as the abnce of upper gastrointestinal hemorrhage (i.e.,stable hematocrit and vital signs,and abnce of hematemesis)for 8hr after treatment,while in the study by Gimson et al.(11),control of active variceal hemorrhage was de fined as hemostasis 12hr after the first endoscopic examina-tion with stable vital signs and packed-cell volume and no hematemesis.Hou et al.(9)de fined success in arrest-ing variceal bleeding as stable vital signs with no sign of rebleeding within 24hr of treatment,while in the study by Lo et al.(10),initial success was de fined as cessation of bleeding for more than 72hr,together with stable vital signs.
Our results con firm the earlier reports of a lower fre-quency of variceal rebleeding in patients with portal hyper-tension after EVL.The lower frequency of rebleeding in EVL could be attributed to the shorter variceal “kill time ”(time required for variceal obliteration).In our study re-bleeding occurred in two cas (4%).In the study by Sarin et al.(14),the rebleeding rate was 6.4%(3/47patients);similar results were reported by Lo et al.(17%)and Hou et al.(19%)(6/36and 13/67patients,respectively)(9,10)
.Stiegman et al.(13),showed a rebleeding rate of 36%(23/64patients);Gimson et al.(11),30%(16/54
patients).
Fig 7.Single-shot mechanism.Endoscopic tunnel vision.
Digestive Dias and Sciences,Vol.50,No.2(February 2005)
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T ABLE4.C OMPLICATIONS AND M ORTALITY
Complications
Chest pain2(4%)
Fever2(4%)
Aspiration pneumonia1(2%)
Mortality
Hepatic failure3(6%)
In this study,rebleeding was defined as upper GI hemor-rhage(hematemsis or melena)before variceal obliteration has occurred.In the study by Stiegmann et al.(13),it was defined as a subquent upper GI hemorrhage that resulted in an unscheduled endoscopy,a need for blood transfusion, or exsanguination,while in the study by Gimson et al.(11), it was defined as upper GI hemorrhage that required en-doscopy and was associated with a fall in hemoglobin of more than20g/L.Lo et al.(10)defined rebleeding from esophageal varices as the reappearance of hematemesis or melena after initial success and the bleeding source was confirmed to be from esophageal varices by repeat endoscopy.Episodes of GI bleeding from sources other than esophageal varices were also recorded.They recorded bleeding from an esophageal ulcer induced by endoscopic treatment as an episode of rebleeding rather than as a com-plication.Only tho necessitating a blood transfusion of 2units or more were considered rebleeding.Insignificant bleeding such as scanty tarry stool and clear aspirates from a nasogastric tube that did not need blood transfusion was not recorded.Hou et al.(9)defined rebleeding as new on-t of hematemasis,coffee ground vomitus,hematochezia, or melena with an increasing pul rate of over110bpm and decreasi
ng blood pressure below90mm Hg.
In our study,the overall incidence of rebleeding was lower than in the previous studies,which may be ex-plained by the lesr number of ssions needed to oblit-erate varices(3.1±1.25).In the study by Sarin et al.(14), the mean number of treatment ssions till obliteration was 4.4±1.2.Baroncini et al.(15)reported the mean number of treatment ssions to be3.5±0.1;similar results were reported in the study by Gimson et al.(3.4)and Laine et al.
(4.1)(11,12).
Variceal eradication was achieved in47of50(94%) patients in this study.In the study by Stiegmann et al.(13), variceal obliteration occured in27patients of64(42%). In the study by Lain et al.(12)varices were eradicated in 58%(22/38).In the study by Lo et al.(10),varices were eradicated in74%,while in the study by Baroncini et al.
(15)EVL was effective in eradicating93%of varices.And in the study by Saeed(8)eradication was achieved in17 of26(70%).In our study eradication was defined as the abscence of any varices in the treated gment in the EIS group and the prence only of vesls too small to be ligated in the EVL group.
In summary,the u of the Six-Shooter has improved the quality of vision and the avoided the need for an overtube, resulting in the achievement of faster variceal eradication with fewer complications.
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