Presents a comprehensive, systematic assessment of available scientific evidence for effects on health, social welfare or disability. Full assessments include economic, social and ethical impact analyses. Assessment teams include professional practitioners and academics. Before publication the report is reviewed by external experts, and scientific conclusions approved by the SBU Board of Directors.
Every year about 13 000 patients have their gallbladder removed because of gallstone disease (cholecystectomy) in Sweden and 30 to 40 will suffer a surgically inflicted injury to the bile ducts. An X-ray investigation of the bile ducts (intraoperative cholangiography (IOC)) is done routinely in all patients. This report compares routine use with use in selected patients.
- The risk of bile duct injury is probably reduced if intraoperative cholangiography is used routinely compared with doing it only when the surgeon finds it necessary. The type of injuries that are avoided may require extensive surgery to correct, may cause long-standing suffering with reduced quality of life and, may in worst case cause the death of the patient.
- When IOC is used routinely the total dose of radiation to the patient group is larger than if it is done in selected patients. It is assumed that approximately 40% of all patients in Sweden could be eligible for a selective investigation. The added dose of irradiation given when IOC is used routinely is estimated to induce one extra case of cancer among the 26 000 patients who undergo surgery during a 2-year period.
- In a health economic model analysis, the basecase scenario using IOC routinely is estimated to avoid a bile duct injury in seven patients per year in Sweden compared with selective use. The yearly cost for routinely used IOC is estimated to be 14.5 million Swedish crowns (SEK) (1.41 million EUR (1 EUR =10.3 SEK)) higher than if used selectively. This is balanced by a reduction of cost of approximately 6 million SEK (580 000 EUR) per year because of the bile duct injuries that are avoided.
- When an injury due to surgery is prevented, undue suffering for the patient is avoided. In the base case scenario, the cost per saved quality adjusted life year is approximately 300 000 SEK (29 100 EUR) if IOC is used routinely instead of selectively.
SBU has evaluated benefits, risks, costs and ethical consequences of using IOC routinely compared to selective use.
There is no data on outcomes and risks of using selective IOC in a Swedish setting. Thus, several assumptions, some uncertain, based on data in the literature have been made in the model analysis. This is reflected in the sensitivity analysis.
The project was suggested by the Swedish Surgical Society with aim to create a scientific basis for a national clinical guideline for gallstone surgery.
Bile duct injuries caused in gallstone surgery varies from small lesions in the bile duct wall to complete transections of a bile duct. Small injuries can usually be repaired with minor procedures while larger injuries may require extensive surgery and reoperations. For the latter there is a risk of late strictures requiring further surgery. Patients may also die from complications to the injuries.
In Sweden a surgically inflicted bile duct injury occurs in 0.3% of all cholecystectomies. This equals 30–40 injuries per year whereof about one third are serious. Data suggests that bile duct injuries are more common and more serious internationally than in Sweden. The anatomy of the bile ducts varies and only about 60% of western people have a typical anatomy. An IOC during cholecystectomy aims to visualise the bile duct anatomy before the gallbladder is removed. In Sweden an IOC is performed or attempted in 94% of all cholecystectomies. The alternative, which is more common internationally, is to do the investigation when the surgeon finds it necessary during the operation.
In Sweden about 40% of all cholecystectomies are done because of complications to gallstone disease, mostly cholecystitis. Theoretically could an IOC be warranted in all these cases.
To evaluate benefit, risks, costs and ethical consequences of using IOC routinely instead of selectively at cholecystectomy.
The report is a systematic review of the literature with evidence evaluation according to GRADE combined with a health economic model analysis.
In the metanalysis of data from the literature, the rate of bile duct injuries was 0.53% in patient groups where IOC was done in selectively (or not at all) compared with 0.36% in the groups where IOC was used routinely. The ingoing studies are heterogenous, but some include a very large number of patients. In total, the metanalysis includes more than 2 million patients undergoing a cholecystectomy and of those, 9 000 suffered a surgically induced bile duct injury.
When IOC is used routinely the total dose of radiation given to the patient group as a whole is larger (additional 16 Sievert) than if IOC is done selectively. The added dose is estimated to induce one extra cancer case at a later stage in the 26 000 patients who are undergoing a cholecystectomy in Sweden during a 2-year period.
In the health economic model’s base case assuming an increased risk for bile duct injury of 43% when IOC is done selectively, it is estimated that seven injuries will be avoided per year in Sweden where IOC is done routinely. Thirty-three quality adjusted life years (QALYs) are saved at a net cost of 8.5 million SEK (825 000 EUR). The cost for each saved QALY is approximately 300 000 SEK (29 100 EUR). In a life time perspective, the cost per saved QALY will be less.
In the sensitivity analysis the cost per saved QALY when using IOC routinely varies from cost-saving to 700 000 SEK (68 000 EUR). The assumptions which affects the model outcome most are the risk of injury when IOC is used selectively, the impact of an injury on the patient’s quality of life over time and the proportion of patients that undergo an IOC in a setting with a selective strategy.
We lack data on outcome and risks for bile duct injuries if IOC is done selectively in a Swedish setting.
An ethical aspect is the balance between gaining benefit and risking a decrease in heath from a procedure. A bile duct injury may greatly affect a patient’s quality of life and may be deadly. These risks will be reduced if bile duct injuries can be avoided. On the contrary, the added dose of radiation from routinely used IOC may infer a risk of extra cancer cases in the long run.
Full report in Swedish
The full report in Swedish "Intraoperativ kolangiografi vid kolecystektomi"
- Claes Jönsson, Malmö/Lund (Chair)
- Lars Enochsson, Umeå
- Bengt Hallerbäck, Trollhättan
- Peter Leander, Malmö
- Agneta Montgomery, Malmö
- Johanna Österberg, Mora
- Jan Adolfsson (Project Manager)
- Pia Johansson (Health Economist)
- Johanna Wiss (Health Economist)
- Anneth Syversson (Project Administrator)
- Hanna Olofsson (Information Specialist)
- Maja Kärrman Fredriksson (Information Specialist)
- GallRiks. Årsrapport 2016.
- Rystedt JML, Tingstedt B, Montgomery F, Montgomery AK. Routine intraoperative cholangiography during cholecystectomy is a cost-effective approach when analysing the cost of iatrogenic bile duct injuries. HPB (Oxford). 2017;19:881-8.
- Chamberlain RS. Essential functional hepatic and biliary anatomy for the surgeon. Hepatic Surg. 2013.
- Cucchetti A, Peri E, Cescon M, Zanello M, Ercolani G, Zanfi C, et al. Anatomic variations of intrahepatic bile ducts in a European series and meta-analysis of the literature. J Gastrointest Surg 2011;15:623-30.
- Hussein AM, Botros SM, Abdelhafez AH, Mahfouz M. Biliary tree variations as viewed by intra-operative cholangiography – Comparing Egyptian versus international data. Egypt J RadiolNucl Med 2016;47:1283-92.
- Chun K. Recent classifications of the common bile duct injury. Korean J Hepatobil Pancreat Surg 2014;18:69-72.
- Sahajpal AK, Chow SC, Dixon E, Greig PD, Gallinger S, Wei AC. Bile duct injuries associated with laparoscopic cholecystectomy: timing of repair and long-term outcomes. Arch Surg 2010;145:757-63.
- Tornqvist B, Stromberg C, Persson G, Nilsson M. Effect of intended intraoperative cholangiography and early detection of bile duct injury on survival after cholecystectomy: population based cohort study. BMJ 2012;345:e6457.
- Barbier L, Souche R, Slim K, Ah-Soune P. Long-term consequences of bile duct injury after cholecystectomy. J Visc Surg 2014;151:269-79.
- Goykhman Y, Kory I, Small R, Kessler A, Klausner JM, Nakache R, et al. Long-term outcome and risk factors of failure after bile duct injury repair. J Gastrointest Surg 2008;12:1412-7.
- Parrilla P, Robles R, Varo E, Jimenez C, Sanchez-Cabus S, Pareja E, et al. Liver transplantation for bile duct injury after open and laparoscopic cholecystectomy. Br J Surg 2014;101:63-8.
- Flum DR, Flowers C, Veenstra DL. A cost-effectiveness analysis of intraoperative cholangiography in the prevention of bile duct injury during laparoscopic cholecystectomy. J Am Coll Surg 2003;196:385-93.
- Booij KAC, De Reuver PR, Yap K, Van Dieren S, Van Delden OM, Rauws EA, et al. Morbidity and mortality after minor bile duct injury following laparoscopic cholecystectomy. Endoscopy 2015;47:40-6.
- de Reuver PR, Sprangers MA, Rauws EA, Lameris JS, Busch OR, van Gulik TM, et al. Impact of bile duct injury after laparoscopic cholecystectomy on quality of life: a longitudinal study after multidisciplinary treatment. Endoscopy 2008;40:637-43.
- Dominguez-Rosado I, Mercado MA, Kauffman C, Ramirez-del Val F, Elnecave-Olaiz A, Zamora-Valdes D. Quality of life in bile duct injury: 1-,5-, and 10-year outcomes after surgical repair. J Gastrointest Surg 2014;18:2089-94.
- Hogan AM, Hoti E, Winter DC,Ridgway PF, Maguire D, Geoghegan JG, et al. Quality of life after iatrogenic bileduct injury: a case control study. Ann Surg 2009;249:292-5.
- Karvonen J, Gronroos JM, Makitalo L, Koivisto M, Salminen P. Quality of life after iatrogenic bile duct injury - a case control study. Min Invasive Ther Allied Technol 2013;22:177-80.
- Moore DE, Feurer ID, Holzman MD, Wudel LJ, Strickland C, Gorden DL, et al. Long-term detrimental effect of bile duct injury on health-related quality of life. Arch Surg 2004;139:476-81;discussion 81-2.
- Xu XD, Zhang YC, Gao P, BahraniMougeot F, Zhang LY, He ZY, et al. Treatment of major laparoscopic bile duct injury: a long-term follow-up result. Amer Surg 2011;77:1584-8.
- Ejaz A, Spolverato G, Kim Y, Dodson R, Sicklick JK, Pitt HA, et al. Long-term health-related quality of life after iatrogenic bile duct injury repair. J Am Coll Surg 2014;219:923-32 e10.
- Landman MP, Feurer ID, Moore DE, Zaydfudim V, Pinson CW. The longterm effect of bile duct injuries on health-related quality of life: a metaanalysis. HPB (Oxford) 2013;15:252-9.
- Sarmiento JM, Farnell MB, Nagorney DM, Hodge DO, Harrington JR. Quality-of-life assessment of surgical reconstruction after laparoscopic cholecystectomy-induced bile duct injuries:what happens at 5 years and beyond? Arch Surg 2004;139:483-8.
- Boerma D, Rauws EA, Keulemans YC, Bergman JJ, Obertop H, Huibregtse K, et al. Impaired quality of life 5 years after bile duct injury during laparoscopic cholecystectomy: a prospective analysis. Ann Surg 2001;234:750-7.
- Hariharan D, Psaltis E, Scholefield JH, Lobo DN. Quality of life and medicolegal implications following iatrogenic bile duct injuries. World J Surg 2017;41:90-9.
- El-Dhuwaib Y, Slavin J, Corless DJ, Begaj I, Durkin D, Deakin M. Bile duct reconstruction following laparoscopic cholecystectomy in England.Surg Endoscopy Intervent Tech 2016;30:3516-25.
- Törnqvist B, Waage A, Zheng Z, Ye W, Nilsson M. Severity of acute cholecystitis and risk of iatrogenic bile duct injury during cholecystectomy, a populationbased case-control study. World J Surg 2016;40:1060-7.
- Tornqvist B, Stromberg C, Akre O, Enochsson L, Nilsson M. Selective intraoperative cholangiography and risk of bile duct injury during cholecystectomy. Br J Surg 2015;102(8):952-8.
- Trondsen E, Edwin B, Reiertsen O, Faerden AE, Fagertun H, Rosseland AR. Prediction of common bile duct stones prior to cholecystectomy: a prospective validation of a discriminant analysis function. Arch Surg 1998;133:162-6.
- Vecchio R, MacFadyen BV, Latteri S. Laparoscopic cholecystectomy: an analysis on 114,005 cases of United States series. Int Surg 1998;83:215-9. kapitel 11 referenser 67
- International Commission on Radiological Protection. 2007 Recommendations of the International Commission on Radiological Protection (Users Edition). ICRP Publication 103 (Users Edition) Ann ICRP 37 (2-4). 2007.
- Mirizzi PL. Operative cholangiography. Surg Gynecol Obstet 1937;65:702-10.
- Statens beredning för medicinsk och social utvärdering (SBU). Utvärdering av metoder i hälso- och sjukvården.
- Buddingh KT, Weersma RK, Savenije RA, van D, G M, Nieuwenhuijs VB. Lower rate of major bile duct injury and increased intraoperative management of common bile duct stones after implementation of routine intraoperative cholangiography. J Am Coll Surg 2011;213:267-74.
- Fletcher DR, Hobbs MS, Tan P, Valinsky LJ, Hockey RL, Pikora TJ, et al. Complications of cholecystectomy: risks of the laparoscopic approach and protective effects of operative cholangiography: a population-based study. Ann Surg 1999;229:449-57.
- Flum DR, Dellinger EP, Cheadle A, Chan L, Koepsell T. Intraoperative cholangiography and risk of common bile duct injury during cholecystectomy. JAMA 2003;289:1639-44.
- Flum DR, Koepsell T, Heagerty P, Sinanan M, Dellinger EP. Common bile duct injury during laparoscopic cholecystectomy and the use of intraoperative cholangiography: adverse outcome or preventable error? Arch Surg 2001;136:1287-92.
- Giger U, Ouaissi M, Schmitz SF, Krahenbuhl S, Krahenbuhl L. Bile duct injury and use of cholangiography during laparoscopic cholecystectomy. Br J Surg 2011;98:391-6.
- Ragulin-Coyne E, Witkowski ER, Chau Z, Ng SC, Santry HP, Callery MP, et al. Is routine intraoperative cholangiogram necessary in the twenty-first century? A national view. J Gastrointest Surg 2013;17:434-42.
- Sheffield KM, Riall TS, Han Y, Kuo YF, Townsend CM, et al. Association between cholecystectomy with vs without intraoperative cholangiography and risk of common duct injury. JAMA 2013;310:812-20.
- Waage A, Nilsson M. Iatrogenic bile duct injury: a population-based study of 152 776 cholecystectomies in the Swedish Inpatient Registry. Arch Surg 2006;141:1207-13.
- Livingston EH, Miller JA, Coan B, Rege RV. Costs and utilization of intraoperative cholangiography. J Gastrointest Surg 2007;11:1162-7.
- Snow LL, Weinstein LS, Hannon JK, Lane DR. Evaluation of operative cholangiography in 2043 patients undergoing laparoscopic cholecystectomy: a case for the selective operative cholangiogram. Surg Endoscopy 2001;15:14-20.
- Van de Sande S, Bossens M, Parmentier Y, Gigot JF. National survey on cholecystectomy related bile duct injury--public health and financial aspects in Belgian hospitals--1997. Acta Chir Belgica 2003;103:168-80.
- Tandvårds- och läkemedelsförmånsverket (TLV). Läkemedelsförmånsnämndens allmänna råd. 2003.
- Adamsen S, Hansen OH, Funch-Jensen P, Schulze S, Stage JG, Wara P. Bile duct injury during laparoscopic cholecystectomy: a prospective nationwide series. J Am Coll Surg 1997;184:571-8.
- Hamad MA, Nada AA, Abdel-Atty MY, Kawashti AS. Major biliary complications in 2,714 cases of laparoscopic cholecystectomy without intraoperative cholangiography: a multicenter retrospective study. Surg Endoscopy 2011;25:3747-51.
- Fischer CP, Fahy BN, Aloia TA, Bass BL,Gaber AO, Ghobrial RM. Timing of referral impacts surgical outcomes in patients undergoing repair of bile duct injuries. HPB 2009;11(1):32-7.
- Thomson BN, Parks RW, Madhavan KK, Wigmore SJ, Garden OJ. Early specialist repair of biliary injury. Br J Surg 2006;93:216-20.
- Södra regionvårdsnämnden. Regionala priser och ersättningar för södra sjukvårdsregionen 2016.
- Statistiska centralbyrån. Statistikdatabasen: Ettårig livslängdstabell, dödsrisker (promille) efter kön, ålder och år. 2018.
- Socialstyrelsen. Nationella riktlinjer för astma och kol. Metodbeskrivning. 2015.
- Andersson R, Eriksson K, Blind PJ, Tingstedt B. Iatrogenic bile duct injury--a cost analysis. HPB (Oxford) 2008;10:416-9.
- Dageforde LA, Landman MP, Feurer ID, Poulose B, Pinson CW, Moore DE. A cost-effectiveness analysis of early vs late reconstruction of iatrogenic bile duct injuries. J Am Coll Surg 2012;214:919-27.
- Amott D, Webb A, Tulloh B. Prospective comparison of routine and selective operative cholangiography. ANZ J Surg 2005;75:378-82.
- Ding GQ, Cai W, Qin MF. Is intraoperative cholangiography necessary during laparoscopic cholecystectomy for cholelithiasis? World J Gastroenterol 2015;21:2147-51.
- Ford JA, Soop M, Du J, Loveday BP, Rodgers M. Systematic review of intraoperative cholangiography in cholecystectomy. Br J Surg 2012;99:160-7.
- Slim K, Martin G. Does routine intra-operative cholangiography reduce the risk of biliary injury during laparoscopic cholecystectomy? An evidence-based approach. J Visc Surg 2013;150:321-4.
- Sajid MS, Leaver C, Haider Z, Worthington T, Karanjia N, Singh KK. Routine on-table cholangiography during cholecystectomy: a systematic review. Ann R Coll Surg. Engl 2012;94:375-80.
- Wysocki AP. Population-based studies should not be used to justify a policy of routine cholangiography to prevent major bile duct injury during laparoscopic cholecystectomy. World J Surg 2017;41:82-9.
- Buanes T, Waage A, Mjaland O, Solheim K. Bile leak after cholecystectomy significance and treatment:results from the National Norwegian Cholecystectomy Registry. Int Surgery 1996;81:276-9.
- Metcalfe MS, Ong T, Bruening MH, Iswariah H, Wemyss-Holden SA, Maddern GJ. Is laparoscopic intraoperative cholangiogram a matter of routine? Am J Surg 2004;187:475-81.