Evidence based medicine in complicated and uncomplicated gallstone disease van Dijk, A.H.

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1 UvA-DARE (Digital Academic Repository) Evidence based medicine in complicated and uncomplicated gallstone disease van Dijk, A.H. Link to publication Citation for published version (APA): van Dijk, A. H. (2018). Evidence based medicine in complicated and uncomplicated gallstone disease General rights It is not permitted to download or to forward/distribute the text or part of it without the consent of the author(s) and/or copyright holder(s), other than for strictly personal, individual use, unless the work is under an open content license (like Creative Commons). Disclaimer/Complaints regulations If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library: or a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible. UvA-DARE is a service provided by the library of the University of Amsterdam ( Download date: 31 Dec 2018

2 Evidence based medicine in complicated and uncomplicated gallstone disease Aafke van Dijk

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4 Evidence based medicine in complicated and uncomplicated gallstone disease Aafke van Dijk

5 COLOFON Evidence Based Medicine In Complicated And Uncomplicated Gallstone Disease Thesis, University van Amsterdam, The Netherlands Cover design and layout: Paula Berkemeyer (PBVerbeelding.nl) Printed by: Off Page ISBN: A.H. van Dijk, Amsterdam, The Netherlands, 2018 The copyright of the published and accepted articles has been transferred to the respective publishers. No part of this thesis may be reproduced, stored or transmitted, in any form or by any means, without prior permission of the author. The printing of this thesis was financially supported by: Wetenschappelijk fonds Chirurgie AMC, Academisch Medisch Centrum en ABNAMRO

6 Evidence Based Medicine In Complicated And Uncomplicated Gallstone Disease ACADEMISCH PROEFSCHRIFT ter verkrijging van de graad van doctor aan de Universiteit van Amsterdam op gezag van de Rector Magnificus prof. dr. ir. K.I.J. Maex ten overstaan van een door het College voor Promoties ingestelde commissie in het openbaar te verdedigen in de Agnietenkapel op vrijdag 21 december 2018, te uur door Aafke Henrieke van Dijk geboren te Rotterdam

7 Promotiecommissie Promotores Prof. dr. M.A. Boermeester AMC-UvA Prof. dr. M.G.W. Dijkgraaf AMC-UvA Copromotor Dr. P.R. de Reuver Radboud Universiteit Nijmegen Overige leden Prof. dr. W.A. Bemelman Prof. dr. J.J.G.H.M. Bergman Prof. dr. J.F. Lange Prof. dr. M.G.H. Besselink Prof. dr. S.E. Geerlings Dr. J.B. Reitsma AMC-UvA AMC-UvA Erasmus Universiteit Rotterdam AMC-UvA AMC-UvA Universiteit Utrecht Faculteit der Geneeskunde

8 TABLE OF CONTENTS General introduction and outline of the thesis 7 Part 1 Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Part 2 Chapter 7 Chapter 8 Complicated gallstone disease Assessment of available evidence in the management of gallbladder and bile duct stones: a systematic review of international guidelines. Preoperative clinical diagnosis, liver function tests and abdominal ultrasound as predictors of common bile duct stones during laparoscopic cholecystectomy. Short- and long-term outcomes after a reconstituting and fenestrating subtotal cholecystectomy. A systematic review of cystic duct closure techniques in relation to prevention of bile duct leakage after laparoscopic cholecystectomy. Effectiveness of antibiotics after spillage of bile and gallstones during laparoscopic cholecystectomy. Systematic review of antibiotic treatment for acute calculous cholecystitis. Uncomplicated gallstone disease A randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy in patients with symptomatic gallstones (SECURE trial protocol). Statistical analysis plan of a randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy (SECURE trial)

9 Chapter 9 A randomized controlled trial to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy in patients with symptomatic gallstones (SECURE trial). 195 Appendices Summary and future perspectives 221 Nederlandse samenvatting 227 Phd portfolio 235 List of publications 239 Dankwoord 243 About the author 247

10 General introduction and outline of the thesis Adapted from: Laparoscopy in cholecysto-choledocholithiasis. Van Dijk AH, Lamberts M, van Laarhoven CJHM, Drenth JPH, Boermeester MA, de Reuver PR. Best Pract Res Clin Gastroenterol Feb

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12 General introduction GENERAL INTRODUCTION Gallstone disease (cholelithiasis) is one of the most common gastroenterological disorders, associated with significant morbidity and increasing costs. Estimated prevalence is 10 20% in Europe and America [1]. Gallstones are the result from a disbalance in the physical-chemical composition of bile. Most patients with gallstones remain asymptomatic. When patients develop symptoms of biliary colic or complicated gallstone disease, such as cholecystitis, cholangitis and biliary pancreatitis, there is an indication for treatment [2]. 9 Diagnostics in cholelithiasis The typical presentation of a patient with uncomplicated cholecystolithiasis is a biliary colic. The definition of a biliary colic is described by the Rome criteria and define a biliary colic as a steady pain, usually located in epigastrium and/or in the right upper quadrant, lasting 30 minutes or longer [3]. International guidelines on the treatment of symptomatic gallstones all advocate surgery based on these mainly expert opinion-based criteria composed in Secondly, in routine clinical care patients often present with less typical abdominal symptoms that can be attributed to coexistent gallstones or to other abdominal diseases [4]. In a prospective cohort study by Berger et al neither biliary colic nor any other gastrointestinal symptom was directly related to gallstone disease [5]. Therefore, the diagnosis of symptomatic cholecystolithiasis cannot be based solely on the presence of biliary colic and additional workup or imaging might be needed is some patients. It would be of great clinical value to be able to preoperatively identify patients who benefit from cholecystectomy. The diagnostic tool of choice for cholelithiasis is abdominal ultrasound, with a sensitivity of 0.81 (CI ) and a specificity of 0.83 (CI ) [6]. Other diagnostic modalities, such as endoscopy or computed tomography (CT), can help differentiate between uncomplicated gallstone disease and other causes of abdominal symptoms in patients, but should be used only when absolutely necessary [7]. Cholecystectomy and postoperative outcomes Cholecystectomy is generally accepted as the treatment of choice for symptomatic gallstone disease and is one of the most frequently performed surgical procedures in the Western world. At the end of the 1980s laparoscopy was introduced and Mühe performed the first laparoscopic cholecystectomy (LC) in Germany in September 1985 [8]. Within 5 years time, LC was declared to be the gold standard instead of open cholecystectomy. Numerous studies, assembled in a Cochrane Systematic Review, have reported that LC results in a shorter hospital stay, speedier recovery, reduction of postoperative pain and better cosmetic results compared with open surgery [9]. A standardized work-up and indication for surgery in cholecystolithiasis is lacking in international guidelines, which results in a variety of indications for cholecystectomy in general, among surgeons and between countries [10]. Since the indication for gallbladder removal is not evidence based, additional research is necessary to optimize the indication for LC in cho-

13 10 lecystolithiasis. In a patient with complicated cholelithiasis (i.e. choledocholithiasis, acute cholecystitis, biliary pancreatitis or cholangitis) the indication for LC is clear, since morbidity and mortality are reduced by cholecystectomy. The main purpose of cholecystectomy in this group is symptom relief. A review aimed to assess the effectiveness of elective cholecystectomy on persistent symptoms. The most often reported persistent symptoms are diarrhea and constipation; upper abdominal pain persists in up to 30 % of the patients [11]. This is extremely high for a mostly elective surgery, especially since a standardized workup is lacking and indication for surgery is not based on evidence. Prophylactic antibiotics in elective LC are not advocated since meta-analyses show there is no evidence for reduction of infectious outcomes [12]. However, the evidence for administering intra-operative prophylactic antibiotics in patients following spill of bile and/or gallstones or postoperative antibiotic in patients diagnosed with acute cholecystitis is lacking. Subtotal cholecystectomy is a possible bail out procedure in a difficult cholecystectomy, to prevent postoperative complications, especially bile duct injuries. It is most often used if identification of the common bile duct and other anatomical structures is problematic due to adhesions/fibrosis or severe inflammation [13]. There are several operative techniques how to perform a subtotal cholecystectomy as safe as possible. The most frequent complications reported were bile leakage (most often from a not closed or not adequately closed cystic duct) and the formation of new gallstones or the residual of gallstones in the remnant of the gallbladder [14]. Overall LC is associated with 0-0.2% overall mortality and % morbidity versus open cholecystectomy with a mortality rate of 0-0.5% and a morbidity rate of 4%-17.8% [4,15]. Postoperative complications associated with LC include intraoperative spill of bile and/or stones, bile leakage and bile duct injury, intraabdominal infection and wound infections. Choledocholithiasis Symptomatic choledocholithiasis is defined as the presence of gallstones in the common bile duct with associated symptoms [16]. These symptoms include dark urine, acholic stools, and jaundice. Of all patients with stones in the gallbladder, 5-20% have concomitant common bile duct stones [17]. The indication for further investigation of common bile duct stones is based on a combination of both clinical, laboratory and radiological outcomes. The sensitivity and specificity of clinical, laboratory and radiological outcomes vary in research and it is unclear if they can preoperatively be used to correctly predict the presence of common bile duct stones [18]. Aim of the thesis In summary, most management in complicated and uncomplicated gallstone disease is not based on evidence, but seems to be mostly expert opinion. The first part of this thesis focuses on complicated gallstones disease and starts with exploring where evidence is lacking in the management of gallstone disease by reviewing international guidelines. The role of laboratory tests in the diagnosis of common bile duct stones is also assessed. Furthermore, the

14 General introduction outcomes of subtotal cholecystectomy as an alternative in difficult cholecystectomy and methods of closing the cystic duct during laparoscopic cholecystectomy are evaluated. The first part of this thesis concludes with the use of antibiotics in acute cholecystitis and the effectiveness of antibiotics following spill of bile and/or stones during cholecystectomy. The second part of this thesis focuses on uncomplicated gallstone disease and consists of the SECURE trial, a randomized multicenter trial comparing a restrictive strategy to usual care for the effectiveness of cholecystectomy in symptomatic patients with uncomplicated gallstone disease. 11 OUTLINE OF THE THESIS This thesis focuses on the evidence-based management of uncomplicated and complicated gallstone disease. The thesis is divided into two parts. The first part of this thesis deals with patients with complicated gallstone disease. In Chapter 1 we assessed the available evidence in the management of cholelithiasis and common bile duct stones, by reviewing all available international guidelines on the management of gallstone disease. In Chapter 2 the role of clinical diagnosis, abdominal ultrasound and preoperative liver function tests in the prediction of common bile duct stones are evaluated with a prospective study. Chapter 3 describes the outcomes of the subtotal cholecystectomy as an alternative in difficult cholecystectomy. To evaluate if there is a preferable technique of closing the cystic duct during cholecystectomy to prevent cystic duct leakage, we systematically reviewed available evidence in Chapter 4. The effectiveness of antibiotics after spillage of bile and/or gallstones is discussed in Chapter 5. As it is unclear if acute cholecystitis should be treated with antibiotics, we present the results of a systematic review on that subject in Chapter 6. The second part of this thesis focuses on uncomplicated gallstone disease and especially on the indication for cholecystectomy in patients with abdominal pain and gallstones. Chapter 7 includes the study protocol of the SECURE trial. Cholecystectomy is standard treatment in patients with symptomatic gallstones. Up to 40% of patients describe persistent abdominal pain following cholecystectomy, so cholecystectomy is not always effective. In addition to persistent pain, multiple studies report differences in indication and variation in practice in cholecystectomy for patients with symptomatic gallstones. The SECURE trial was designed to compare a restrictive strategy to usual care for the effectiveness of cholecystectomy in symptomatic patients with uncomplicated gallstone disease. The statistical analysis plan of the SECURE trial is displayed in Chapter 8. The clinical results of the SECURE trial are reported in Chapter 9.

15 REFERENCES Everhart JE, Khare M, Hill M, Maurer KR. Prevalence and ethnic differences in gallbladder disease in the United States. Gastroenterology Sep;117(3): Stokes CS, Krawczyk M, Lammert F. Gallstones: environment, lifestyle and genes. Dig Dis Jan;29(2): The Rome Group for Epidemiology and Prevention of Cholelithiasis (GREPCO). The epidemiology of gallstone disease in Rome, Italy. Part II. Factors associated with the disease. Hepatology. 1988;8(4): Keus F, Broeders IAMJ, van Laarhoven CJHM. Gallstone disease: Surgical aspects of symptomatic cholecystolithiasis and acute cholecystitis. Best Pract Res Clin Gastroenterol Jan;20(6): Berger MY, Olde Hartman TC, van der Velden JJIM, Bohnen AM. Is biliary pain exclusively related to gallbladder stones? A controlled prospective study. Br J Gen Pract Aug;54(505): Kiewiet JJS, Leeuwenburgh MMN, Bipat S, Bossuyt PMM, Stoker J, Boermeester MA. A systematic review and meta-analysis of diagnostic performance of imaging in acute cholecystitis. Radiology Sep;264(3): Duncan CB, Riall TS. Evidence-Based Current Surgical Practice: Calculous Gallbladder Disease. J Gastrointest Surg Sep 18;16(11): Reynolds W. The first laparoscopic cholecystectomy. JSLS. 2001;5(1): Keus F, de Jong JAF, Gooszen HG, van Laarhoven CJHM. Laparoscopic versus open cholecystectomy for patients with symptomatic cholecystolithiasis. Cochrane Database Syst Rev Jan;(4):CD Harrison EM, O Neill S, Meurs TS, Wong PL, Duxbury M, Paterson-Brown S, et al. Hospital volume and patient outcomes after cholecystectomy in Scotland: retrospective, national population based study. BMJ Jan 23;344(may23_1):e Lamberts MP, Lugtenberg M, Rovers MM, Roukema AJ, Drenth JPH, Westert GP, et al. Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness. Surg Endosc Mar;27(3): Sanabria A, Dominguez LC, Valdivieso E, Gomez G. Antibiotic prophylaxis for patients undergoing elective laparoscopic cholecystectomy. In: Sanabria A, editor. Cochrane Database Syst Rev. Chichester, UK: John Wiley & Sons, Ltd; p. CD Michalowski K, Bornman PC, Krige JE, Gallagher PJ, Terblanche J. Laparoscopic subtotal cholecystectomy in patients with complicated acute cholecystitis or fibrosis. Br J Surg Jul;85(7): Henneman D, da Costa DW, Vrouenraets BC, van Wagensveld BA, Lagarde SM. Laparoscopic partial cholecystectomy for the difficult gallbladder: a systematic review. Surg Endosc Feb;27(2):351 8.

16 General introduction 15. Ingraham AM, Cohen ME, Ko CY, Hall BL. A current profile and assessment of north american cholecystectomy: results from the american college of surgeons national surgical quality improvement program. J Am Coll Surg Aug;211(2): Boerma D, Schwartz MP. Gallstone disease. Management of common bile-duct stones and associated gallbladder stones: Surgical aspects. Best Pract Res Clin Gastroenterol Jan;20(6): Tazuma S. Epidemiology, pathogenesis, and classification of biliary stones (common bile duct and intrahepatic). Best Pract Res Clin Gastroenterol Jan;20(6): Gurusamy KS, Giljaca V, Takwoingi Y, Higgie D, Poropat G, Štimac D, et al. Ultrasound versus liver function tests for diagnosis of common bile duct stones. In: Gurusamy KS, editor. Cochrane Database Syst Rev. Chichester, UK: John Wiley & Sons, Ltd;