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Laparoscopic treatment of duodenal ulcer: A plea for clinical trials
SELECTED SUMMARIES
December 1991
should have been deferred for more convincing evidence of effectiveness of the same procedure by open laparotomy. On the other hand, it can be argued, as these authors do, that the laparoscopist’s fine instruments and magnified images allow more precise dissection and promise better results. It thus follows that the place of laparoscopic surgery in the treatment of duodenal ulcers must be determined by its own risks and recurrence rates. Cure of duodenal ulcers requires complete separation of all parietal cells from vagal innervation. Any technique that leaves even a small patch of innervated parietal cells will allow some ulcers to behave as if they had never been treated. Variations in vagal anatomy have always frustrated surgeons, especially in performing parietal cell vagotomy, in which beginners experience ulcer recurrence rates of up to 30% (Br J Surg 1987;74:1056-1059). Failures were attributed to dissecting too little esophagus, missing the posterior “criminal nerve,” and leaving the first antral branch in the vascular “crow’s foot.” None of these errors were avoided with certainty in the present study. Moreover, one must worry that parietal cells medial to the lesser curve seromyotomy remain innervated and responsive to vagal stimulation. Having cited these reservations, however, we must acknowledge that equally rational reservations were once held about other treatments that have subsequently proved to be effective. Thus, surgeons who are well trained in laparoscopic techniques should be encouraged to test this procedure in a controlled comparison with its proven counterpart, parietal cell vagotomy. Such a trial might yield one of three possible conclusions. One possibility is that laparoscopic vagotomy’s effect is no more sustained than medical therapy, in which case the operation should be abandoned. The second possibility is that it is as effective and innocuous as parietal cell vagotomy, in which case it should become the elective operation of choice for duodenal ulcers. The third possibility is somewhere in between, i.e., that it is not quite as effective as parietal cell vagotomy but cures 70%-80% of duodenal ulcers. What shall we do with that conclusion? Should the contest between drugs and procedures be won by novelty, charm, or profitability of laparoscopy? America’s leading manufacturer of laparoscopic equipment, charged with falsifying orders and securities law violations, has a 650-person sales force committed to answering such questions in favor of profit by selling laparoscopy to the public as well as to surgeons (Wall Street Journal, April 16, 1991). Might this be the “trend of thought” presaged by the present study? Laparoscopic anterior lesser curve seromyotomy plus posterior truncal vagotomy is certainly an interesting procedure for the treatment of duodenal ulcer; its efficacy remains to be proven. Guidelines and safeguards clarifying the indications, safety, efficacy, and training for this procedure must be developed. It is imperative that this new procedure be at first restricted to carefully controlled prospective randomized trials in which patients are followed for at least 5 years. H. H. McGUIRE,JR., M.D. M. L. SCHUBERT, M.D.
Reply. Kurt Semm of Kiel, Germany, performed the first laparoscopic appendectomy in 1982, and Philippe Mouret of Lyon, France, performed the first laparoscopic cholecystectomy in 1987. They opened a new era in abdominal surgery, and the fact that “600,000 patients are being considered candidates for laparoscopic cholecystectomy” is not frightening; it simply shows that there is a large consensus among surgeons on how to give the best possible treatment to their patients. Indeed, if “commercial profiteering” existed in the beginning, it was condemned by the majority of surgeons. Currently, many papers published in recognized scientific journals clearly show the benefit of laparoscopic treatment,
1745
placing ethical constraints on the planning of randomized controlled trials (Br J Surg 1991;78:150-154). Regarding the posterior vagotomg and anterior lesser curve seromyotomy by videocoelioscopy, the whole of the posterior gastric wall is denervated by the division of the posterior vagus trunk. There is no need, therefore, to worry about Grassi’s “criminal branch,” accused of being responsible for the recurrence in duodenal ulcer surgery by incomplete vagotomy. The technique we propose is the same one we have performed in open surgery for years with good long-term results, and different publications have shown its effectiveness and safety in the treatment of chronic duodenal ulcer. However, the laparoscopy procedure is not easy and must be considered an advanced technique requiring thorough experimental practice, and we insist on this point in our conclusion in the published study. We also point out that this study was an initial one, and long-term results will be the subject of another publication. Finally, we believe the traditional books of abdominal or general surgery need to be rewritten. The “trend of thought” must be distinguished from the “material trend”: it represents a new philosophy of operation, resulting in a shorter and more comfortable hospital stay for patients and a financial savings for health care institutions. N. KATKHOUDA.
M.D.
ALCOHOL ABUSE AND LIVER DISEASE: TRUE, TRUE, BUT NOT NECESSARILY RELATED Takase S, Takada N, Enomoto N, et al. (Division of Gastroenterology, Department of Internal Medicine, Kanazawa Medical University, Uchinada, Ishikawa, Japan). Different types of chronic hepatitis in alcoholic patients: does chronic hepatitis induced by alcohol exist? Hepatology 1991;13:876881 (May). The authors selected 27 patients from their alcoholic patient population because each showed histological evidence of chronic active hepatitis (CAH) and each had sera available for retrospective analysis of viral markers. The number of alcohol-abusing patients from which these cases are selected is not stated. Two with CAH who did not have sera available are not included in the study. The cases were divided into groups based on the serological findings: the AL group (7 cases; 26%) had no markers for either hepatitis C virus (HCV) or hepatitis B virus (HBV); the HB group (4 cases; 15%) were positive for hepatitis B surface antigen (HBsAg); the HCl group (7 cases; 26%) were positive for anti-HCV but negative for HCV RNA genome by a polymerase chain reaction (PCR); and. the HC2 group (9 cases; 33%) had both anti-HCV and the HCV genome. A history of blood transfusions was obtained in 2 of 7 patients in the AL group, in 6 of 16 with evidence of HCV (HCl and HC2), and in 0 of 4 in the HB group. There were no significant differences between groups in results of initial conventional liver tests. Serum aspartate aminotransferase and alanine aminotransferase levels declined during 4 weeks of abstinence in most patients in the AL and HCl groups but not in the HB or HC2 groups. Serum desialotransferrin and alcohol liver membrane antibodies were detected more frequently in the sera of patients in the AL and HCl groups. There was a trend [not statistically significant) toward increased frequency of centrilobular ballooning in the AL group. The
December 1991
should have been deferred for more convincing evidence of effectiveness of the same procedure by open laparotomy. On the other hand, it can be argued, as these authors do, that the laparoscopist’s fine instruments and magnified images allow more precise dissection and promise better results. It thus follows that the place of laparoscopic surgery in the treatment of duodenal ulcers must be determined by its own risks and recurrence rates. Cure of duodenal ulcers requires complete separation of all parietal cells from vagal innervation. Any technique that leaves even a small patch of innervated parietal cells will allow some ulcers to behave as if they had never been treated. Variations in vagal anatomy have always frustrated surgeons, especially in performing parietal cell vagotomy, in which beginners experience ulcer recurrence rates of up to 30% (Br J Surg 1987;74:1056-1059). Failures were attributed to dissecting too little esophagus, missing the posterior “criminal nerve,” and leaving the first antral branch in the vascular “crow’s foot.” None of these errors were avoided with certainty in the present study. Moreover, one must worry that parietal cells medial to the lesser curve seromyotomy remain innervated and responsive to vagal stimulation. Having cited these reservations, however, we must acknowledge that equally rational reservations were once held about other treatments that have subsequently proved to be effective. Thus, surgeons who are well trained in laparoscopic techniques should be encouraged to test this procedure in a controlled comparison with its proven counterpart, parietal cell vagotomy. Such a trial might yield one of three possible conclusions. One possibility is that laparoscopic vagotomy’s effect is no more sustained than medical therapy, in which case the operation should be abandoned. The second possibility is that it is as effective and innocuous as parietal cell vagotomy, in which case it should become the elective operation of choice for duodenal ulcers. The third possibility is somewhere in between, i.e., that it is not quite as effective as parietal cell vagotomy but cures 70%-80% of duodenal ulcers. What shall we do with that conclusion? Should the contest between drugs and procedures be won by novelty, charm, or profitability of laparoscopy? America’s leading manufacturer of laparoscopic equipment, charged with falsifying orders and securities law violations, has a 650-person sales force committed to answering such questions in favor of profit by selling laparoscopy to the public as well as to surgeons (Wall Street Journal, April 16, 1991). Might this be the “trend of thought” presaged by the present study? Laparoscopic anterior lesser curve seromyotomy plus posterior truncal vagotomy is certainly an interesting procedure for the treatment of duodenal ulcer; its efficacy remains to be proven. Guidelines and safeguards clarifying the indications, safety, efficacy, and training for this procedure must be developed. It is imperative that this new procedure be at first restricted to carefully controlled prospective randomized trials in which patients are followed for at least 5 years. H. H. McGUIRE,JR., M.D. M. L. SCHUBERT, M.D.
Reply. Kurt Semm of Kiel, Germany, performed the first laparoscopic appendectomy in 1982, and Philippe Mouret of Lyon, France, performed the first laparoscopic cholecystectomy in 1987. They opened a new era in abdominal surgery, and the fact that “600,000 patients are being considered candidates for laparoscopic cholecystectomy” is not frightening; it simply shows that there is a large consensus among surgeons on how to give the best possible treatment to their patients. Indeed, if “commercial profiteering” existed in the beginning, it was condemned by the majority of surgeons. Currently, many papers published in recognized scientific journals clearly show the benefit of laparoscopic treatment,
1745
placing ethical constraints on the planning of randomized controlled trials (Br J Surg 1991;78:150-154). Regarding the posterior vagotomg and anterior lesser curve seromyotomy by videocoelioscopy, the whole of the posterior gastric wall is denervated by the division of the posterior vagus trunk. There is no need, therefore, to worry about Grassi’s “criminal branch,” accused of being responsible for the recurrence in duodenal ulcer surgery by incomplete vagotomy. The technique we propose is the same one we have performed in open surgery for years with good long-term results, and different publications have shown its effectiveness and safety in the treatment of chronic duodenal ulcer. However, the laparoscopy procedure is not easy and must be considered an advanced technique requiring thorough experimental practice, and we insist on this point in our conclusion in the published study. We also point out that this study was an initial one, and long-term results will be the subject of another publication. Finally, we believe the traditional books of abdominal or general surgery need to be rewritten. The “trend of thought” must be distinguished from the “material trend”: it represents a new philosophy of operation, resulting in a shorter and more comfortable hospital stay for patients and a financial savings for health care institutions. N. KATKHOUDA.
M.D.
ALCOHOL ABUSE AND LIVER DISEASE: TRUE, TRUE, BUT NOT NECESSARILY RELATED Takase S, Takada N, Enomoto N, et al. (Division of Gastroenterology, Department of Internal Medicine, Kanazawa Medical University, Uchinada, Ishikawa, Japan). Different types of chronic hepatitis in alcoholic patients: does chronic hepatitis induced by alcohol exist? Hepatology 1991;13:876881 (May). The authors selected 27 patients from their alcoholic patient population because each showed histological evidence of chronic active hepatitis (CAH) and each had sera available for retrospective analysis of viral markers. The number of alcohol-abusing patients from which these cases are selected is not stated. Two with CAH who did not have sera available are not included in the study. The cases were divided into groups based on the serological findings: the AL group (7 cases; 26%) had no markers for either hepatitis C virus (HCV) or hepatitis B virus (HBV); the HB group (4 cases; 15%) were positive for hepatitis B surface antigen (HBsAg); the HCl group (7 cases; 26%) were positive for anti-HCV but negative for HCV RNA genome by a polymerase chain reaction (PCR); and. the HC2 group (9 cases; 33%) had both anti-HCV and the HCV genome. A history of blood transfusions was obtained in 2 of 7 patients in the AL group, in 6 of 16 with evidence of HCV (HCl and HC2), and in 0 of 4 in the HB group. There were no significant differences between groups in results of initial conventional liver tests. Serum aspartate aminotransferase and alanine aminotransferase levels declined during 4 weeks of abstinence in most patients in the AL and HCl groups but not in the HB or HC2 groups. Serum desialotransferrin and alcohol liver membrane antibodies were detected more frequently in the sera of patients in the AL and HCl groups. There was a trend [not statistically significant) toward increased frequency of centrilobular ballooning in the AL group. The