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Endoscopic Management of Postcholecystectomy Bile Duct Strictures
LETTERS
Position Statement: Surgical Innovations
tive of the need for objective third-party oversight of innovations. Although the definition of research seems clear, the lines can become blurred when moving from a minor variation to an innovation, to formal research. The context is important, and that is where the Surgical Innovations Committee can be most helpful. We wholeheartedly agree with Dr Morgenstern that the critical issue is disclosure and transparency—with our patients and our colleagues.
Leon Morgenstern, MD, FACS Los Angeles, CA The Society of University Surgeons is to be commended for addressing the issue of surgical innovation so comprehensively and constructively.1 Surgical innovation can present some thorny ethical issues that have been only too rarely discussed in major surgical journals or at major surgical meetings. This position statement is a much-needed guide to correct that deficiency. I question the example given of an innovation that might not meet the criteria for human subject research, namely the ad-hoc decision of a surgeon to perform an appendectomy per vaginam. I do think this qualifies as human subject research and should be subject to the process recommended in the position statement. In addition, I believe that in the interest of full disclosure, a planned innovation must be disclosed to the patient or surrogate rather than have the disclosure just recommended. Transparency in disclosure should also apply to corporate sponsorship of human subject research, in which the innovator stands to benefit by material reward.The same goes for the disclosure of the perils of the learning curve, which should be discussed in obtaining the informed consent for any innovative procedure. Proposing another hurdle for the innovator, such as a local Surgical Innovations Committee is likely to be greeted with less than enthusiasm and critiqued as just another obstacle to innovation. I welcome the idea as a necessary refinement of the current IRB practices. IRBs, in my opinion, lack the necessary expertise or ability in the oversight needed to assure proper evaluation of surgical innovations. The position paper is a major contribution to the ethical aspects of surgical innovation.
Endoscopic Management of Postcholecystectomy Bile Duct Strictures Juha M Grönroos, MD Turku, Finland I read with interest the fine article by Vitale and coauthors1 on endoscopic managements of postcholecystectomy bile duct strictures. I agree with the authors that the role of endoscopic procedures as mini-invasive treatment modalities has proved pivotal in the treatment of these severe lesions. In my opinion, their overall results are excellent when compared with the earlier literature. Of a total of 67 patients with severe (Amsterdam B, C, and D) bile duct injuries, the definitive treatment modality of the lesion was endoscopic in 44 and hepaticojejunostomy in 23 patients in the mean followup of 30 months. Here, I emphasize the role of two recent improvements in the field on endoscopic techniques, the clinical value of which has not been discussed extensively in the literature, but that I trust will improve markedly the success rate and feasibility of miniinvasive treatment modalities in iatrogenic bile duct injuries. First, the rendezvous procedure,2 which is indicated in patients in whom stenting of an iatrogenic bile duct stricture from endoscopic approach only proves unsuccessful. This failure in endoscopic stenting every now and then occurs in iatrogenic strictures, in particular, because these lesions are usually located high up in the common hepatic duct near the confluence. In rendezvous procedure, an interventional radiologist introduces a percutaneous transhepatic guidewire and drain into bile ducts and duodenum. After that, an endoscopist picks up the duodenal end of the long guidewire into the duodenoscope and out of that. The other end of the guidewire remains in the hands of the radiologist. Then, by pulling gently at both ends of the guidewire, the guidewire is stiff enough for endoscopic stenting, usually without difficulties—contrary to what is
REFERENCE 1. Biffl WL, Spain DA, Reitsma A, et al. Responsible development and application of surgical innovations: a position statement of Society of University Surgeons. J Am Coll Surg 2008;206:1204–1209.
Reply Walter L Biffl, MD, FACS Denver, CO We appreciate Dr Morgenstern’s comments. His disagreement with our example of an innovation is illustra-
© 2008 by the American College of Surgeons Published by Elsevier Inc.
786
ISSN 1072-7515/08/$34.00 doi:10.1016/j.jamcollsurg.2008.08.025
Vol. 207, No. 5, November 2008
the case in these patients if the guidewire is introduced endoscopically only. Once the iatrogenic stricture has been passed with endoscopic stent at rendezvous procedure, repeated procedures in the followup, such as dilations and stent exchanges are usually easily performed using endoscopic approach only. In the 1990s, there was a report in the literature on biliary rendezvous procedures performed because of malignant strictures.3 To my knowledge, my report2 was the first one on rendezvous procedures performed because of iatrogenic bile duct injuries. I find that rendezvous procedure is of utmost clinical importance in the treatment of iatrogenic bile duct injuries in patients with unsuccessful stenting through endoscopic approach only, in particular in those with both stricture and leakage. Using this technique, many unnecessary, often hazardous early laparotomies to repair the lesion can be avoided. Second, the removable self-expanding metallic stents (SEMS). Earlier, use of SEMSs for benign biliary strictures has been contraindicated or at least controversial, because these devices were considered irremovable. Recently, a simple and safe technique was described for the removal of one of the commonest SEMSs.4 The former makes possible the transient dilation of benign biliary strictures using removable SEMSs. Preliminary descriptive data on 55 patients treated with covered SEMS for benign biliary strictures were extremely encouraging with resolution of the stricture in 90% of patients, although most of the patients suffered from a stricture caused by chronic pancreatitis, often considered extremely resistant to endoscopic therapy.5 A removable SEMS is a particularly fascinating option for the treatment of iatrogenic bile duct strictures because SEMS enables to easily attain a large dilation diameter in a single endoscopy session, which makes the therapy more feasible for the patient. Prospective randomized trials are warranted to determine the role of SEMS in the treatment of iatrogenic bile duct strictures. Last year, we reported the occurrence, treatment, and longterm results of iatrogenic bile duct injuries sustained during laparoscopic cholecystectomy in and aroundTurku University Central Hospital 1995 to 2002.6 In our study, the definitive treatment of 88% of the Amsterdam C strictures was endoscopic and percutaneous, but only 12% of the patients with Amsterdam C strictures had to undergo laparotomy.
REFERENCES 1. Vitale GC, Tran TC, Davis BR, et al. Endoscopic managements of postcholecystectomy bile duct strictures. J Am Coll Surg 2008; 206:918–923. 2. Grönroos JM. Unsuccessful endoscopic stenting in iatrogenic bile duct injury: remember rendezvous procedure. Surg Laparosc Endosc Percutan Tech 2007;17:186–189.
Letters
787
3. Shlansky-Goldberg RD, Ginsberg GG, Cope C. Percutaneous puncture of the common bile duct as a rendezvous procedure to cross a difficult biliary obstruction. J Vasc Interv Radiol 1995;6: 943–946. 4. Kahaleh M, Tokar J, Le T, Yeaton P. Removal of self-expandable metallic Wallstents. Gastrointest Endosc 2004;60:640–644. 5. Kahaleh M, Brock A, De La Rue SA, et al. Temporary placement of covered self expandable metal stents (SEMS) in benign biliary strictures: preliminary data. Gastrointest Endosc 2005;61: AB208. 6. Karvonen J, Gullichsen R, Laine S, et al. Bile duct injuries during laparoscopic cholecystectomy: primary and long-term results from a single institution. Surg Endosc 2007;21:1069–1073.
Reply Gary C Vitale, MD, FACS Louisville, KY The rendezvous procedure is a well-established approach to obtain biliary access when endoscopic cannulation fails. It is safe and allows internalization of stents placed percutaneously. Covered metallic stents, which can be removed in shortterm use, can be of benefit in those strictures, but has yet proved to be safe or superior to plastic stents. These stents can migrate and cause bile leak when removed. Most of our stenting was for substantial strictures that required 1 year of stenting. Metallic stents can be difficult to remove because of growth of granulation after that length of time. Although rendezvous is an acceptable alternative approach in patients difficult to cannulate, metallic stenting in this setting can be considered a promising possibility, but not a new paradigm.
Isolation of Right Main and Sectional Portal Pedicles for Liver Resection Without Hepatotomy or Inflow Occlusion Marcel Autran Machado, MD, Antonio C Martins, MD, Marcel C Machado, MD, FACS Sao Paulo, Brazil We read with great interest the article by Strasberg and colleagues1 in the “Surgeon at Work” section of the February 2008 Journal of the American College of Surgeons issue, titled, “Isolation of right main and sectional portal pedicles
Position Statement: Surgical Innovations
tive of the need for objective third-party oversight of innovations. Although the definition of research seems clear, the lines can become blurred when moving from a minor variation to an innovation, to formal research. The context is important, and that is where the Surgical Innovations Committee can be most helpful. We wholeheartedly agree with Dr Morgenstern that the critical issue is disclosure and transparency—with our patients and our colleagues.
Leon Morgenstern, MD, FACS Los Angeles, CA The Society of University Surgeons is to be commended for addressing the issue of surgical innovation so comprehensively and constructively.1 Surgical innovation can present some thorny ethical issues that have been only too rarely discussed in major surgical journals or at major surgical meetings. This position statement is a much-needed guide to correct that deficiency. I question the example given of an innovation that might not meet the criteria for human subject research, namely the ad-hoc decision of a surgeon to perform an appendectomy per vaginam. I do think this qualifies as human subject research and should be subject to the process recommended in the position statement. In addition, I believe that in the interest of full disclosure, a planned innovation must be disclosed to the patient or surrogate rather than have the disclosure just recommended. Transparency in disclosure should also apply to corporate sponsorship of human subject research, in which the innovator stands to benefit by material reward.The same goes for the disclosure of the perils of the learning curve, which should be discussed in obtaining the informed consent for any innovative procedure. Proposing another hurdle for the innovator, such as a local Surgical Innovations Committee is likely to be greeted with less than enthusiasm and critiqued as just another obstacle to innovation. I welcome the idea as a necessary refinement of the current IRB practices. IRBs, in my opinion, lack the necessary expertise or ability in the oversight needed to assure proper evaluation of surgical innovations. The position paper is a major contribution to the ethical aspects of surgical innovation.
Endoscopic Management of Postcholecystectomy Bile Duct Strictures Juha M Grönroos, MD Turku, Finland I read with interest the fine article by Vitale and coauthors1 on endoscopic managements of postcholecystectomy bile duct strictures. I agree with the authors that the role of endoscopic procedures as mini-invasive treatment modalities has proved pivotal in the treatment of these severe lesions. In my opinion, their overall results are excellent when compared with the earlier literature. Of a total of 67 patients with severe (Amsterdam B, C, and D) bile duct injuries, the definitive treatment modality of the lesion was endoscopic in 44 and hepaticojejunostomy in 23 patients in the mean followup of 30 months. Here, I emphasize the role of two recent improvements in the field on endoscopic techniques, the clinical value of which has not been discussed extensively in the literature, but that I trust will improve markedly the success rate and feasibility of miniinvasive treatment modalities in iatrogenic bile duct injuries. First, the rendezvous procedure,2 which is indicated in patients in whom stenting of an iatrogenic bile duct stricture from endoscopic approach only proves unsuccessful. This failure in endoscopic stenting every now and then occurs in iatrogenic strictures, in particular, because these lesions are usually located high up in the common hepatic duct near the confluence. In rendezvous procedure, an interventional radiologist introduces a percutaneous transhepatic guidewire and drain into bile ducts and duodenum. After that, an endoscopist picks up the duodenal end of the long guidewire into the duodenoscope and out of that. The other end of the guidewire remains in the hands of the radiologist. Then, by pulling gently at both ends of the guidewire, the guidewire is stiff enough for endoscopic stenting, usually without difficulties—contrary to what is
REFERENCE 1. Biffl WL, Spain DA, Reitsma A, et al. Responsible development and application of surgical innovations: a position statement of Society of University Surgeons. J Am Coll Surg 2008;206:1204–1209.
Reply Walter L Biffl, MD, FACS Denver, CO We appreciate Dr Morgenstern’s comments. His disagreement with our example of an innovation is illustra-
© 2008 by the American College of Surgeons Published by Elsevier Inc.
786
ISSN 1072-7515/08/$34.00 doi:10.1016/j.jamcollsurg.2008.08.025
Vol. 207, No. 5, November 2008
the case in these patients if the guidewire is introduced endoscopically only. Once the iatrogenic stricture has been passed with endoscopic stent at rendezvous procedure, repeated procedures in the followup, such as dilations and stent exchanges are usually easily performed using endoscopic approach only. In the 1990s, there was a report in the literature on biliary rendezvous procedures performed because of malignant strictures.3 To my knowledge, my report2 was the first one on rendezvous procedures performed because of iatrogenic bile duct injuries. I find that rendezvous procedure is of utmost clinical importance in the treatment of iatrogenic bile duct injuries in patients with unsuccessful stenting through endoscopic approach only, in particular in those with both stricture and leakage. Using this technique, many unnecessary, often hazardous early laparotomies to repair the lesion can be avoided. Second, the removable self-expanding metallic stents (SEMS). Earlier, use of SEMSs for benign biliary strictures has been contraindicated or at least controversial, because these devices were considered irremovable. Recently, a simple and safe technique was described for the removal of one of the commonest SEMSs.4 The former makes possible the transient dilation of benign biliary strictures using removable SEMSs. Preliminary descriptive data on 55 patients treated with covered SEMS for benign biliary strictures were extremely encouraging with resolution of the stricture in 90% of patients, although most of the patients suffered from a stricture caused by chronic pancreatitis, often considered extremely resistant to endoscopic therapy.5 A removable SEMS is a particularly fascinating option for the treatment of iatrogenic bile duct strictures because SEMS enables to easily attain a large dilation diameter in a single endoscopy session, which makes the therapy more feasible for the patient. Prospective randomized trials are warranted to determine the role of SEMS in the treatment of iatrogenic bile duct strictures. Last year, we reported the occurrence, treatment, and longterm results of iatrogenic bile duct injuries sustained during laparoscopic cholecystectomy in and aroundTurku University Central Hospital 1995 to 2002.6 In our study, the definitive treatment of 88% of the Amsterdam C strictures was endoscopic and percutaneous, but only 12% of the patients with Amsterdam C strictures had to undergo laparotomy.
REFERENCES 1. Vitale GC, Tran TC, Davis BR, et al. Endoscopic managements of postcholecystectomy bile duct strictures. J Am Coll Surg 2008; 206:918–923. 2. Grönroos JM. Unsuccessful endoscopic stenting in iatrogenic bile duct injury: remember rendezvous procedure. Surg Laparosc Endosc Percutan Tech 2007;17:186–189.
Letters
787
3. Shlansky-Goldberg RD, Ginsberg GG, Cope C. Percutaneous puncture of the common bile duct as a rendezvous procedure to cross a difficult biliary obstruction. J Vasc Interv Radiol 1995;6: 943–946. 4. Kahaleh M, Tokar J, Le T, Yeaton P. Removal of self-expandable metallic Wallstents. Gastrointest Endosc 2004;60:640–644. 5. Kahaleh M, Brock A, De La Rue SA, et al. Temporary placement of covered self expandable metal stents (SEMS) in benign biliary strictures: preliminary data. Gastrointest Endosc 2005;61: AB208. 6. Karvonen J, Gullichsen R, Laine S, et al. Bile duct injuries during laparoscopic cholecystectomy: primary and long-term results from a single institution. Surg Endosc 2007;21:1069–1073.
Reply Gary C Vitale, MD, FACS Louisville, KY The rendezvous procedure is a well-established approach to obtain biliary access when endoscopic cannulation fails. It is safe and allows internalization of stents placed percutaneously. Covered metallic stents, which can be removed in shortterm use, can be of benefit in those strictures, but has yet proved to be safe or superior to plastic stents. These stents can migrate and cause bile leak when removed. Most of our stenting was for substantial strictures that required 1 year of stenting. Metallic stents can be difficult to remove because of growth of granulation after that length of time. Although rendezvous is an acceptable alternative approach in patients difficult to cannulate, metallic stenting in this setting can be considered a promising possibility, but not a new paradigm.
Isolation of Right Main and Sectional Portal Pedicles for Liver Resection Without Hepatotomy or Inflow Occlusion Marcel Autran Machado, MD, Antonio C Martins, MD, Marcel C Machado, MD, FACS Sao Paulo, Brazil We read with great interest the article by Strasberg and colleagues1 in the “Surgeon at Work” section of the February 2008 Journal of the American College of Surgeons issue, titled, “Isolation of right main and sectional portal pedicles