Surgical treatment of gallbladder stones – bile cutting or bile preservation?

  The idea of writing an article on “Surgical treatment of gallbladder stones – bile cutting or bile preservation?” The idea of writing an article has been around for a long time. On the one hand, more and more gallbladder stone patients are coming to the clinic for gallbladder preservation surgery, and on the other hand, more and more patients who had previously undergone gallbladder preservation surgery are coming to the clinic with recurring stones and suffering from pain. Last year, an article “Surgical Treatment of Gallbladder Stones – Evidence-based Medical Considerations on Gallbladder Removal and Biliary Stone Retrieval”, which I co-authored with Associate Professor Wu Gang of our hospital, was published in Shanghai Medicine. The article describes “Surgical treatment of gallbladder stones – gallbladder excision or bile preservation?” The article provides an objective description of “Surgical treatment of gallbladder stones – bile cutting or bile preservation? Since the article was published in a professional journal, the main arguments of the article are summarized as follows to facilitate the understanding of patients; the original article is also attached for further understanding of patients.  The main arguments: 1. Biliary stone extraction for gallbladder stones has not been included in any treatment guidelines and routines for gallbladder stones. At present, less than 5000 cases are reported nationwide, and 2/3 of the cases are concentrated in small and medium-sized hospitals at non-provincial level, while gallbladder stone extraction for gallbladder stones is not routinely carried out in Europe and the United States, where medicine is relatively advanced.  2. About 20-40% of gallbladder stone patients may be asymptomatic for life or have only very mild symptoms, often without special treatment. In China, most of the indications for gallbladder stone extraction mainly cover this group of patients, therefore, for most of these patients, either gallbladder removal or gallbladder stone extraction has the risk of over-treatment.  3. In patients after biliary lithotripsy, the recurrence rate of stones is very high, and the long-term use of cholestatic drugs after surgery is detrimental to liver function. Cases of gallbladder cancer have been reported after biliary preservation.  4. If patients strongly request biliary preservation, they must fully understand the disadvantages of biliary preservation and meet the rather strict conditions before it is worth trying, in order to provide a basis for in-depth research on the actual clinical use of biliary lithotripsy.  Gallbladder stones are a common disease at home and abroad, and a survey of 6844 permanent residents aged 20-79 years at Ruijin Hospital of Shanghai Jiaotong University Medical College found that 2.49% had undergone cholecystectomy and 9.06% had not yet undergone surgery, with a combined rate of 11.55%. The high number of patients with gallbladder stones is both a medical and a socioeconomic problem. Since 1882 Langenbuch has treated gallbladder stones by open cholecystectomy for more than 100 years, it has become the standard of care for gallbladder stones because of its proven efficacy. However, oral lithotripsy, perfusion lithotripsy, extracorporeal shock wave lithotripsy, and combined Chinese and Western medicine have all been abandoned due to their limited efficacy and high recurrence rate. With the development of laparoscopic technology, laparoscopic cholecystectomy (LC) is now the “gold standard” for the treatment of gallbladder stones.  In the past 20 years, some scholars in China have challenged the traditional cholecystectomy treatment for gallbladder stones and considered that endoscopic cholecystectomy for patients with good gallbladder function is expected to be one of the alternative treatments to cholecystectomy. Although biliary stone extraction has been performed for nearly 20 years, it is currently performed in only 29 hospitals nationwide, with less than 5000 cases reported, and 2/3 of the cases are concentrated in small and medium-sized hospitals at non-provincial levels, and 2/3 of the papers report less than 100 cases, which is a world away from the widespread development of LC [5]. Although surgical removal of the gallbladder avoids the recurrence of gallbladder stones, it also brings a series of problems caused by the loss of the gallbladder to the patient. The loss of the gallbladder’s function of concentrating, storing, and discharging bile after gallbladder removal causes a significant increase in the incidence of dyspepsia, bloating, and diarrhea, as well as an increased incidence of common bile duct stones.  Evidence Based Medicine (EBM) is clinical medicine that follows scientific evidence. It advocates combining the clinician’s personal clinical practice and experience with objective scientific research evidence to bring the most correct diagnosis, the safest and most effective treatment, and the most accurate prognosis estimate to each specific patient. The core idea of evidence-based medicine is that “any health care program or decision should be determined by the best evidence generated by objective clinical scientific research”, so that scientific preventive measures and measures can be developed to prevent disease, promote health and improve the quality of life. The best clinical evidence, skilled clinical experience and patient’s specific situation are the three main elements that are organically combined, and the clinical evidence mainly comes from large samples of randomized controlled trial (RCT) and systematic review or meta-analysis. We will analyze and consider the potential clinical application of biliary stone extraction for gallbladder stones from the viewpoint of evidence-based medicine.  The relative surgical indications for cholecystectomy for gallbladder stones are well known, but there are no recognized indications for cholecystectomy for gallbladder stones, and it has not been included in the treatment guidelines and routines for gallbladder stones. The indications vary widely from domestic and international literature, with asymptomatic or mildly symptomatic gallbladder stones with good gallbladder function predominating in China, and sporadic reports in foreign literature, with high-risk patients with acute cholecystitis who cannot tolerate anesthesia and major surgery as the main pairs.  In the newly published technical specifications for minimally invasive endoscopic cholecystectomy for stone (polyp) extraction by the Chinese Physicians Association Endoscopist Branch industry, the indications for the procedure include: 1) diagnosis of gallbladder stones by ultrasound or other imaging examinations; 2) Tc99 ECT or oral cholecystography with visualization of the gallbladder and good function; 3) although Tc99 ECT or or oral cholecystography is not visualized, the stones can be removed intraoperatively Those with confirmed bile duct patency. 5) no more than 3 single or multiple stones with a diameter of <1 cm; 6) exclusion of embedded stones, gallbladder mutations, malignant gallbladder lesions, etc.; 7) most of the literature takes the patient's requirement for biliary preservation as an important indication. The study by Wong and Sugiyama et al. focused on percutaneous cholecystolith extraction in elderly patients with acute cholecystitis combined with significant organ insufficiency.  About 20-40% of patients with gallbladder stones are asymptomatic, the so-called "silent stone", and most of these patients do not have complications related to gallbladder stones and often do not require special treatment. Most of these patients do not have any complications related to gallbladder stones. In China, most of the indications for cholecystectomy mainly cover this group of patients, and it is controversial to perform cholecystectomy in these patients. Therefore, for most of these patients, either cholecystectomy or cholecystectomy is a risk of overtreatment and can cause waste of medical resources.  The gallbladder has extremely complex and important functions, and is an indispensable and important digestive and immune organ. Cholecystectomy not only removes the stones, but also eradicates the "breeding ground" for stones to grow. However, cholecystectomy is costly for patients: 1) dyspepsia, bloating, diarrhea; 2) reflux gastritis and esophagitis; 3) increased chance of common bile duct stones; 4) cholecystectomy is an invasive operation, which causes medically induced injuries that cannot and cannot be completely avoided; 5) changes in intestinal and hepatic circulation and lipid metabolism after cholecystectomy cannot be fully compensated for. The above-mentioned adverse effects of cholecystectomy are the theoretical basis for gallbladder stone extraction.  Lithotripsy, instillation drug lithotripsy, extracorporeal shock wave lithotripsy, percutaneous cholecystolithotripsy lithotripsy and gallbladder closure are not effective and have been abandoned [3,4]. The gallbladder provides a storage and stagnation condition for stone formation, and the pathophysiological abnormalities of the gallbladder itself, together with hypercholesterolemia and lithogenic bile, are the main causes of gallbladder stones, while the bile comes from the liver and originates from pathological cholesterol metabolism and other abnormalities. Therefore, for some patients, stones are the "symptoms", while the liver and lithogenic bile are the "root", and only by treating both symptoms and root can gallbladder stones be treated at the root. Since lithogenic bile comes from the liver, if there is a breakthrough in the study of the cause of stones, if the abnormal metabolism of lithogenic bile can be corrected, and if the treatment is supplemented with the prevention of stone recurrence after the extraction and preservation of bile, then it may be more reasonable to preserve bile than to remove the functional gallbladder. In a meta-analysis by Gu Hao et al, a total of 15 articles with 1733 cases were collected before November 2008. retrospective clinical analysis, and all were graded as level 4 evidence according to the quality of evidence in evidence-based medicine. Conclusion For cases meeting the indications, with few complications and low recurrence rate of newer biliary stone extraction, this author concluded that biliary stone extraction is an ideal new treatment option for patients with gallbladder stones. The debate on the necessity and feasibility of biliary stone extraction focuses on four aspects: 1) whether the presence of the gallbladder is a breeding ground for gallbladder stone recurrence, which is the cornerstone of the theoretical validity of biliary stone extraction; 2) the indications for biliary stone extraction, i.e., whether all gallbladder stones need or can be biliary stone extracted; 3) what is the immediate and long-term recurrence rate after surgery; and 4) whether the original pathological changes in the gallbladder can be reversed [3].  The current studies on the causes of gallbladder stones include disturbances in the thermodynamic balance of the cholesterol dissolution system, abnormal biliary motility dynamics, imbalances in the balance of nucleating/anti-nucleating factors in bile, genes associated with gallstone formation, and bacterial stone formation. The lack of reliable treatment to prevent stone recurrence after biliary lithotripsy makes the high recurrence rate of gallbladder stones after biliary lithotripsy a major concern. 10-year follow-up data with a recurrence rate of 41.6% [13]. In contrast, a study by Tudyka et al. concluded that gallbladder stone lysis treatment with ursodeoxycholic acid, aspirin and dietary control reduced the recurrence rate of stones. Zhongshan Hospital of Fudan University followed up 792 patients whose stones had disappeared under conservative treatment and the results were 11.6%, 22.3%, 24.5%, 36.4%, 39.3% and 39.6% recurrence rates of gallstones at 1, 2, 3, 4, 5 and more than 5 years, respectively [5]. Liu Jingshan et al. reported 760 cases of fiberoptic choledochoscopic cholecystotomy for stone extraction with oral ursodeoxycholic acid after surgery, and the effective follow-up data were analyzed for survival and the postoperative recurrence rates were calculated using the life table method, and the recurrence rates of gallbladder stones at 1, 2, 3, 4, 5, 7, 9 and 10-15 years were 0.49%, 4.39%, 5.83%, 6.60%, 6.60 6.60%, 7.21%, 8.38% and 10.11%, respectively. According to standard case selection and surgical specifications, the recurrence rate was 5% in the intermediate stage and 10% in the distant stage, mostly within 1 to 2 years [5]. Wang Huiqun et al. analyzed the domestic literature on 16 cases of 4507 bile-preserving lithotripsy patients, with a recurrence rate of 0.8% (2/256) to 26.5% (31/117) at a follow-up of 1 month to 10 years.  4. Prospects for biliary stone extraction There is no evidence-based evidence of prospective, large-sample, multicenter randomized controlled studies on biliary stone extraction for gallbladder stones. Since the introduction of laparoscopic cholecystectomy by Mouret, a French physician, in 1987, LC has gradually replaced OC as the "gold standard" for the treatment of gallbladder stones [15]. We believe that laparoscopic cholecystectomy is a revolution in minimally invasive techniques, but there is no breakthrough in the principles and philosophy of gallbladder stone treatment. In contrast, endoscopic cholecystectomy is a technical improvement in the context of high-tech development, and there is a lack of evidence-based medical evidence to prove that it is an innovation. The indications for gallbladder stone extraction in patients with gallbladder stones have not yet been included in the routine treatment of gallbladder stones, and the implementation of gallbladder stone extraction in patients with gallbladder stones should be performed with extreme caution.  In the choice of gallbladder stone treatment strategy, the indications for cholecystectomy are clear in most patients with gallbladder stones, and retrospective studies cannot be used to prove the superiority of biliary stone extraction. We oppose both the blind removal of a functioning gallbladder without clinical signs and overtreatment, and the blind biliary stone extraction. Our current predictable treatment options for gallbladder stones include: 1) strengthening experimental studies on the causes of stones to prevent the formation of gallbladder stones; 2) in the early stage of gallbladder stone formation, when the gallbladder is still functioning well, some patients with indications can be treated with cholecystectomy, combined with postoperative prophylactic treatment to reduce the rate of stone regeneration and recurrence; 3) gallbladder stone patients with clear indications for cholecystectomy are treated with cholecyst (3) gallbladder resection for patients with clear indications for gallbladder stone surgery.  According to the requirements of evidence-based medicine, the practical value of a new technology needs to be evaluated in five aspects, namely feasibility, efficacy, effectiveness, efficiency, and whether it can become the gold standard procedure, which requires a prospective, large sample, multicenter randomized controlled study to clinically evaluate biliary stone extraction. Therefore, it is too early to confirm or reject the use of biliary lithotripsy for gallbladder stones, and it is difficult to assess the actual clinical value of biliary lithotripsy, so further in-depth studies are needed.