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The coning ofage ofband ligation for oesophagealvarices.pdf


									                                                                                                 LONDON, SATURDAY 4 MAY 1996

The coning of age of band ligation for oesophageal varices
Al the evidence shows it has better outcomes than injection sclerotherapy
In this age of evidence based medicine one question that             errors and showed the superiority of ligation over sclero-
remains hard to answer is at what stage the results of clinical      therapy for the four main outcomes of rebleeding, local com-
trials should lead to changes in clinical practice. Even when        plications, time to variceal obliteration, and survival. The
reassured by the size of the sample and quality of the popula-       consistency of these findings surely means that the time has
tion, clinicians seem to remain doubtful about whether clinical      come for band ligation to be recognised as the better technique
practice should be changed on the basis of one or two studies.       and for it to replace injection sclerotherapy.
Not uncommonly, for example, the results from an apparently             Although, even in its present form, band ligation is superior
well conducted study are not borne out or initially conflicting      to injection sclerotherapy, there is room for improvement. One
results eventually become clearer as more data accumulate.           practical problem is that in heavy or torrential variceal haem-
This was the case with the original observation by Lebrec et al      orrhage the suction required for prolapse of the varix into the
that propranolol could reduce rebleeding from oesophageal            banding device usually results in aspiration of sufficient blood
varices,' which was followed rapidly by another study that           to impair visualisation. In this setting, injecting sclerotherapy
showed no benefit whatsoever.2 Nearly all subsequent studies         is easier, and low volume injections to achieve haemostasis
have confirmed the original observations, but people became          may be useful to allow band ligation. An alternative approach
persuaded only when a meta-analysis had been undertaken.3            would be to use vasoactive agents such as the somatostatin
The situation with band ligation for oesophageal varices is dif-     analogue octreotide to reduce active haemorrhage immedi-
ferent: all the studies so far have shown an advantage over the      ately before band ligation.
standard treatment, but it is not yet widely used in clinical
practice.                                                            Room for improvement
   For a decade endoscopic sclerotherapy has been the method            A second, more important, disadvantage of band ligation is
of choice in controlling active variceal haemorrhage, and it has     the requirement to remove the endoscope to reload bands for
been accepted that subsequent injections to achieve variceal         each ligation, which generally requires passage of an overtube
obliteration reduce the risk of further haemorrhage. Recently        for easy insertion of the endoscope and band device. Not only
an alternative endoscopic treatment, band ligation, has been         is passage of the overtube uncomfortable for the patient, it is
introduced, and five randomised clinical trials comparing this       potentially traumatic and in our experience can restart bleed-
treatment with injection sclerotherapy of bleeding oesophageal       ing which has recently stopped, presumably because direct
varices have now been fully reported.                                pressure prevents outflow from varices distally. Two new
                                                                     approaches are currently being evaluated to allow bands to be
The evidence                                                         applied without the endoscope having to be withdrawn. One is
   The first study, by Stiegmann et al, found band ligation to be    a device with multiple bands, each of which can be released
better, with improved survival and fewer complications.4 The         separately, and the second uses endoloops (snares that can be
second study, by Laine et al, reported a significant reduction in    tightened around varices and left to exert pressure) which can
local complications but no difference in rebleeding or mortal-       be passed down the biopsy channel.10 These or similar
ity.' These authors also observed that band ligation obliterated     approaches should make ligation of varices easier.
the varices more rapidly. This last observation was confirmed           The observation that band ligation is superior to injection
by Gimson et al, who also found that band ligation reduced the       sclerotherapy has relevance beyond the substitution of one
incidence of rebleeding but without affecting mortality or           endoscopic technique for another. Other techniques for
complications.6 The fourth study, by Hou et al, found that           controlling variceal bleeding and rebleeding, such as
band ligation was superior in reducing rebleeding and compli-        octreotide, balloon tamponade, and propranolol, have been
cations but not mortality.7 The most recent report, by Lo et al,     compared with injection sclerotherapy. Clearly the relative
found that ligation reduced rebleeding, mortality, and compli-       efficacy of these treatments, particularly those with similar
cations and achieved obliteration more rapidly.8                     effects to sclerotherapy, will need to be reassessed against band
   These trials therefore come to similar conclusions that band      ligation. Similarly, conditions where injection sclerotherapy
ligation is superior to injection sclerotherapy, although there is   has not been found to be particularly useful, such as the pro-
some variation over where the benefit lies. Not surprisingly,        phylaxis of initial variceal haemorrhage, require reassessment
when a meta-analysis of these and other studies was                  using band ligation. New treatments, such as transjugular
undertaken,9 the larger numbers reduced type 2 statistical           intrahepatic portosystemic stent shunts (TIPSS), are currently

BMJ VOLUME 312         4 MAY 1996                                                                                                1111
being compared with injection sclerotherapy."" The evidence                                               7 Hou M-C, Lin H-C, Kuo BI-T, Chen C-H, Lee F-Y, Lee S-D. Comparison of endoscopic
                                                                                                              variceal injection scierotherapy and ligation for the treatment of esophageal variceal
now suggests that they should be compared with the new                                                        hemorrhage: a prospective randomized trial. Hepatology 1995;21:1517-22.
method of choice-band ligation.'5                                                                         8 Lo GH, Lai KH, Cheng JS, Hwu CH, Chang CF, Chang SM, et al. A prospective, randomized
                                                                                                              trial of sclerotherapy versus ligation in the management of bleeding esophageal varices. Hepa-
                                                                                    P C HAYES                 tology 1995;22:466-71.
                                                                                  Senior lecturer         9 Laine L, Cook D. Endoscopic ligation compared with sclerotherapy for treatment of esophageal
                                                                                                              variceal bleeding: a meta-analysis. Ann Intern Med 1995;123:280-7.
Department of Medicine,                                                                                  10 Hepworth CC, Gong F, Kadirkamanathan SS, Middleton S, Brown D, Burnham WR, et al.
Royal Infirmary,                                                                                              Experimental and clinical studies of endoloops: a new method of mechanical haemostasis for
Edinburgh EH3 9YW                                                                                             oesophageal varices. Gut 1995;37(suppl 2):A1.
                                                                                                         11 Sanyal AJ, Freedman AM, Purdum PP, Luketic VA, Shiffman ML, Tisnado J, et al. Transjugu-
1 Lebrec D, Poynard T, Hillon P, Benhamou J-P. Propranolol for prevention of recurrent gastro-                lar intrahepatic portosystemic shunt (TIPS) vs sclerotherapy for prevention of recurrent
   intestinal bleeding in patients with cirrhosis. NEnglJMed 1981;305:1371-4.                                 variceal haemorrhage: a randomized prospective trial [abstract]. Gastoenterology
2 Burroughs AK, Jenkins WJ, Sherlock S, Dunk A, Walt RP, Osuafor TOK, et al. Controlled trial                 1994;106:A975.
    of propranolol for the prevention of recurrent variceal haemorrhage in patients with cirrhosis.      12 Merli M, Riggio 0, Capocaccia L, Ziparo V, Bolognese A, Rossi P, et al. Transjugular intrahe-
   N Engly Med 1983;309:1539-42.                                                                              patic portosystemic shunt vs endoscopic sclerotherapy in preventing variceal rebleeding: pre-
3 Hayes PC, Davis JM, Lewis JA, Bouchier IAD. Meta-analysis of the value of propranolol in pre-               liminary results of a randomized controlled trial [abstract]. Hepatology 1994;20:43.
   vention of variceal haemorrhage. Lancer 1990;i: 153-6.                                                13 Rossle M, Deibert P, Haag K, Ochs A, Siegerstetter V, Langer M. TIPS versus sclerotherapy
4 Stiegmann GV, GoffJS, Michaletz-Onody PA, Korula J, Liebermann D, Saced ZA, et al. Endo-                    and beta-blockade: preliminary results of a randomized study in patients with recurrent
   scopic sclerotherapy as compared with endoscopic ligation for bleeding esophageal varices. N               variceal hemorrhage [abstract]. Hepatology 1994;20:44.
   EnglJMed 1992;326:1527-32.                                                                            14 Cabrera J, Maynar M, Granados R, Gorriz E, Reyes R, Pulido-Duque JM, et al. Transjugular
5 Laine L, El-Newihi HM, Migikovsky B, Sloane R, Garcia F. Endoscopic ligation compared with                  innrahepatic port asystemic shunt versus sclerotherapy in the elective treatment of variceal
    sclerotherapy for the treatment of bleeding esophageal varices. Ann Intern Med 1993;119:1-7.              bleeding. A randomized controlled trial [abstract]. Hepatology 1994;20:425.
6 Gimson AES, Ramage JK, Panos MZ, Hayllar K, Harrison PM, Williams R, et al. Randomised                 15 Jalan R, Forrest EH, Stanley AJ, Redhead DN, Dillon JF, Finlayson NDC, et al. TIPSS vs
    trial of variceal banding ligation versus injection sclerotherapy for bleeding esophageal varices.        variceal band ligation for prevention of variceal rebleeding in cirrhosis: a randomised
    Lancer 1993;342:391-4.                                                                                    controlled study. Gut 1996;38(suppl 1):W24.

The paperless general practice
It is coming, but needs more professional input

The contract between health commissioning authorities and                                                dard semi-automated referral letters); and electronic messag-
general practitioners states that "a doctor shall keep adequate                                          ing (such as for laboratory results).
records of the illness and treatment of his patients on forms                                               Nevertheless, an important part of the record will remain
supplied to him for the purpose." "Form" is clearly a paper                                              free text: the patient's story needs to be captured adequately to
form, yet in 1993 a large national survey found that 8% of                                               enable effective communication through medical records.'"
general practices were already paperless.' The regulations will                                          This requirement for recording the patient's story needs free
probably soon be changed to remove the limitation on paper-                                              text narrative, which is perhaps not always recorded. Of
less records. Are general practitioners and their clinical                                               course, some data currently need to be coded as free text
information systems ready for this legitimisation?                                                       searches but on free text are limited. The proposed "narrative
   Certainly electronic medical records have been admissible                                             model" of the medical record'0 challenges current clinical and
in medical litigation and criminal cases for some years,2 though                                         medical informatics views and perhaps will move us forward.
the Civil Evidence Act requires that the computer system                                                    In summary, what are the pros and cons of the electronic
should be created for the purpose that it is being used; there                                           record and the paper record? The losses are not yet clear, but
should be proper hardware and software maintenance;                                                      where they are visible, as outlined above, they are looking tol-
electronic records should be contemporaneous; and there                                                  erable. The gains improve practice, perhaps significantly, as
should be a full audit trail of additions and deletions. The                                             can be seen from the two recent systematic reviews that
required audit trails are specified in version 3 of the                                                  covered clinical information systems," " which at their heart
requirements for accreditation for general practice computer                                             have the coded electronic medical record.
systems,3 and most systems now conform to at least these sec-                                               In current clinical systems the gains derive from the data
tions. Furthermore, there is now case law of electronic medical                                          entered. With little data in a system there is little gain; this has
records being used as evidence.4 Practices also need to register                                         been the major barrier to progress towards paperless practice.
under the Data Protection Act 1984.' The implication of all                                              Once a reasonable amount of data have been entered,
these changes is that it is (or soon will be) legal to be paperless.                                     however, the data start to work for the clinician and the
   What about confidentiality? This is an important issue of                                             patient-and this provides the incentive to leam new skills.
the moment,6 and the debate about maintaining patient con-                                               Most general practice systems support the basics of paperless
fidentiality needs to be concluded before paperless clinical re-                                         practice, but a few still do not. Technical innovation is also still
cords spread their wings across any wide area network. Never-                                            required in relation to computer interfaces, though one of the
theless, in the "trusted base" of general practice the nine                                              greatest difficulties is reaching a professional consensus so that
Anderson principles of data security6 should be achievable                                               interfaces can be engineered with enough "intelligence" to
given consideration and some changes to systems.                                                         make them quick and intuitive tools.
   Of course, the paperless practice includes more than simply                                              The major issues that need addressing are professional: the
the medical record: it also encompasses administration and                                               production of good practice guidelines for medical records; a
other issues relating to clinical information systems. Paperless                                         review of the purpose, structure, and content of medical
records in their raw electronic text form add only availability                                          records; the authoring of knowledge bases to improve
and legibility to their paper form and lack paper's ability to                                           interfaces; and educating general practitioners about what
carry figurative annotations.8 An electronic record in coded                                             constitutes a quality record and the best use of clinical
form, however, opens the door to many forms of added value.                                              information systems. The system suppliers also have work to
These include automated restructuring of records (such as for                                            do. The requirements for accreditation for general practice
problem lists); queries on data (such as for disease registers or                                        computer systems need a more effective set of user
quality assurance); decision support systems (such as                                                    requirements and evaluation of developments, and these in
PRODIGY9); speeding, guiding, and validating data input (such                                            turn need more input from the clinicians who will use these
as through templates); mailmerge functions (such as for stan-                                            systems. The time of top down processes, led by management

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