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LONDON, SATURDAY 4 MAY 1996 BMT 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 1112 BMJ voLuME 312 4 MAY 1996
"The coning ofage ofband ligation for oesophagealvarices.pdf"