Biliary stone extraction, a procedure that currently attracts patients in many hospitals, for its correctness, begs to differ, a procedure abandoned decades ago, re-emerging in the form of ‘new minimally invasive’, ‘the promotion of the method may not be in line with medical principles, the objective evaluation of a therapeutic measure requires practice plus time The repeated testing of the method, and the hidden worry of misleading the public has gone far beyond the medical activity itself!’
1. Questions about the concept of treatment
It is the general principle for human beings to deal with various diseases by identifying the cause, clarifying the pathogenesis, recognizing the pathophysiological changes related to the disease, and adopting reasonable and effective methods to fundamentally eliminate the cause and restore the normal functional status, and achieving satisfactory results through non-invasive means is the ultimate goal of clinical treatment. However, under today’s conditions, the treatment of many diseases, especially surgical diseases, has not yet reached such an ideal level.
In the case of gallbladder stones, although a lot of progress has been made in the study of the causes of gallbladder stones, the real aspects and specific processes of gallbladder stone formation, whether stones of different morphology, texture, color and size have the same stone formation conditions, genetic predisposition, specific gene function status, objective factors influencing fat metabolism, immune function status, liver function and gastrointestinal tract function status, gallbladder and The specific effects of the structure and function of the bile ducts and the biliopancreatic-intestinal junction on stone formation or the role of each in the stone formation process have not been clearly described.
The complexity of the causes of gallstones can be seen in a particular case in which the gallbladder contained three different colors, shapes and sizes of stones. Although the causes of gallbladder stones remain to be studied in depth, the pathophysiological changes and the actual risks associated with gallbladder stones are well known. Numerous clinicopathological tests have repeatedly confirmed the presence of inflammation and varying degrees of mucosal epithelial hyperplasia in gallbladders containing stones, and at least no completely normal gallbladder containing stones has been reported.
Cholecystitis and gallbladder stones have been described as causal, but the exact relationship between the two is not really clear. It is indisputable that cholecystitis and gallbladder stones often coexist and that cholecystitis leads to structural and functional changes in the gallbladder, and it is unknown under what circumstances and conditions these changes are terminated or reversed simply by the removal of stones.
In addition, chronic inflammation of the gallbladder causes fibrous tissue hyperplasia, thickening and atrophy of the gallbladder wall, and a series of changes in the mucosal epithelium ranging from simple hyperplasia, atypical hyperplasia, to carcinoma in situ and invasive carcinoma, and it is not known whether this process is altered by the simple removal of stones. It has been mentioned that in some cases, the thickening of the gallbladder wall improves significantly after stone removal, but this only suggests that the acute inflammation may have subsided, and does not prove at the histopathological level that the chronic inflammation and its subsequent progression have been fundamentally reversed or no longer recur.
”Preserving the normal function of the gallbladder” is the cornerstone of advocating gallbladder preservation and lithotripsy, but there is no sensitive method or uniform standard for detecting and objectively evaluating the function of the gallbladder, and how to judge the function of the gallbladder with obvious inflammatory changes is even more controversial. I cannot help but ask, is there still a “normal function” of the gallbladder in those with larger stones of 2 cm or more, or tens or even hundreds of smaller stones? How and by whom is their functional status determined? How many cases and how long have we monitored the function of the gallbladder in patients treated with biliary lithotripsy?
In summary, the treatment of gallbladder stones, a common and common disease, is still at a relatively early stage, and there is a lack of effective methods to treat both the symptoms and the root cause. The fact that the gallbladder not only contains stones, but also grows stones, as described by Langenbuch more than 100 years ago, still exists and has not changed slightly due to the changes in the available treatments. Needless to say, cholecystectomy is by no means a perfect and irreplaceable treatment for gallbladder stones, but it is a definitive procedure with proven efficacy that has been tested for more than 100 years.
How to ensure the safety of the procedure is a separate issue and should not be confused with whether the procedure itself should be chosen. On the contrary, the “new minimally invasive biliary preservation” method is still a simple surgical way to “remove” the existing gallbladder stones, but it does not have a verifiable impact on many aspects of stone formation, and the possible impact on the chronic inflammatory process of the gallbladder and gallbladder function is also The possible effects on the chronic inflammatory process of the gallbladder and gallbladder function have yet to be objectively demonstrated.
Since the target organ of gallbladder stone formation is preserved without changing other relevant environmental factors, the risk of recurrence of stones and the persistence and progression of chronic inflammation of the gallbladder, leading to or combining with other serious conditions, continues to increase over time, which is clearly contrary to the basic philosophy of treatment of benign diseases.
The risk of anesthesia and surgical trauma is also experienced, but the target of the problem is not completely solved, but leaves the potential for more serious clinical problems in old age (the serious complications of cholecystitis and gallbladder stones do not need to be mentioned), so can such an approach, which is suspected of “complicating a simple problem”, really overturn more than 100 years of clinical practice? Can such a method, which is suspected of “complicating a simple problem”, really overturn over 100 years of clinical practice?
Is it really more reasonable and effective than cholecystectomy to simply remove the stone as a result and claim that the problem has been properly solved? Unfortunately, the available articles on biliary preservation have confirmed that there is a certain percentage of stone recurrences in the corresponding time period, but whether there are other serious cases among those treated with biliary preservation has not been described, and we hope to see objective reports on this in the future.
2. Questions about technical details
Biliary lithotripsy is not a new clinical treatment technique, as it has been tried on a large scale in many hospitals in China and abroad many years ago, but it was abandoned because it failed to achieve the expected treatment goals. Nowadays, there is a resurgence of “new minimally invasive biliary preservation” methods in China, which only replace the previous laparoscopic or rigid lithotripsy with fiberoptic choledochoscopy, and make some changes in the lithotripsy instruments and the standards of stone removal.
Both the old and newer biliary stone retrieval methods require incision of the gallbladder wall, and the removal of stones may also require dilation of the gallbladder wall incision, which in itself is a mechanical injury to the gallbladder structure and can initiate the process of tissue inflammation and repair, and eventually scar healing. In addition, can mesh basket extraction guarantee no mechanical damage to the mucosa of the gallbladder? Will there be any exudate or bleeding from the damaged gallbladder mucosa and the gallbladder incision suture? Will these exudates become the core of new stones?
Will the tiny stone particles and debris from the lithotripsy process enter the common bile duct and cause other problems during lithotripsy? It is also possible that new factors may be added to the many lithogenic aspects of gallbladder stones and the inflammatory changes in the gallbladder, and that new pathologies such as secondary common bile duct stones and associated mechanical damage to the sphincter of Oddi may result. conditions.
Until these basic questions are answered objectively, it is not logical to represent “new minimally invasive biliary preservation” as having essential and ****ing changes, at least in terms of logic.
3. Questions about potential risks
The objective recurrence rate of stones is already mentioned. Although the 10-year recurrence rate of stones is only 2%-7% as mentioned in the article on gallbladder preservation, it does not address the factors associated with stone recurrence and the specific countermeasures taken for recurring stones. As far as objective gallbladder stones are concerned, the pathophysiological changes and disease progression patterns are the same or similar for both pre-existing and recurrent stones, and there is no essential difference in the chances of leading to serious comorbid conditions.
It is well known that cholecystitis gallbladder stones are closely related to gallbladder cancer, and the latter is precisely one of the most serious and fatal comorbidities that often occur when cholecystitis gallbladder stones are not treated promptly and properly. Every week, I receive new cases of gallbladder cancer related to cholecystitis gallbladder stones, and many patients have not been treated in time for gallbladder stones or misled by improper information, which eventually led to the development of the disease.
The helplessness of patients, the regret of family members, and the helplessness of physicians are all intertwined into a huge psychological impact and a series of big, invisible question marks: Why? Why didn’t we deal with the relatively simple and benign disease in a timely and reasonable manner that could have achieved satisfactory results? Why wait until the disease has progressed to a point where it cannot be effectively treated before thinking of definitive treatment?
Why do some physicians ignore the risk of gallbladder cancer from cholecystitis and gallbladder stones? This is common knowledge that many gallbladder stone patients have known for a long time, but do these physicians really lack the knowledge, or are there other factors? Of course, there is no accurate data on what percentage of patients with untreated gallbladder infections and gallbladder stones will eventually develop gallbladder cancer, but for the individual, once gallbladder cancer occurs, it is 100% a serious problem.
The overall poor outcome of gallbladder cancer is not the focus of this article, but the lack of effective methods for early diagnosis is a real problem for both doctors and patients. Extensive education on the consequences of cholecystitis and gallbladder stones in high-risk groups, as well as increased alertness to the possibility of gallbladder cancer in both doctors and patients, may be an effective way to prevent, detect, and manage gallbladder cancer in a timely manner under present-day conditions. Although the existence of gallbladder carcinoma in patients treated with cholelithiasis is not documented, there is an objective risk of later combined gallbladder carcinoma in those with recurrent stones.
The greater potential risk of gallstone treatment is that patients and family members who lack expertise in the field will completely relax their vigilance about the possibility of gallbladder cancer after treatment, and will the original treating physician make an objective analysis and judgment in case of recurrence or new progress? Will the original treating physician make an objective analysis and judgment when the disease recurs or develops new progress? Will he or she promptly communicate with the patient and suggest another surgery to remove the gallbladder? What kind of follow-up treatment is given to patients with stones or recurrence in current biliary conservation practice? Do patients or their families ever question the rationale for initial biliary stone removal?
How many people are willing to accept a split procedure for a benign condition that could be properly managed with a single procedure, and are willing to take the risk of a more serious condition? Have practitioners of bile preservation seriously analyzed the drawbacks and risks of this method? The author believes that there are still many questions about the rationality of biliary stone extraction, and its potential risks and hazards should be taken seriously and must be studied in depth before a definitive conclusion can be made.
4. Questions about evidence-based medicine
Evidence-based medicine has gradually become a standard way to judge whether clinical treatment methods are reasonable and effective. However, it is difficult to see data and conclusions of randomized controlled studies in the literature related to “new minimally invasive biliary preservation”, and no items related to biliary stone extraction can be found in the RCT registry of research. Some conclusive statements in the classical biliary preservation literature are quite abrupt, such as “the recurrence rate after old biliary preservation is actually mostly due to intraoperative residuals, which should be the residual rate” and “the true incidence of gallbladder cancer is 2 per 100,000;
Cancer should not be used as an excuse to kill! Is it reasonable to kill 100,000 cases of benign gallbladder in order to prevent the occurrence of 2 cases of gallbladder cancer! The incidence of choledocholithiasis increases after cholecystectomy”, etc., and there are several instances of quoting the master surgeon’s words and using slogan-like language to emphasize the correctness, reasonableness, and leadership of his views, which are obviously not in line with the basic principles of evidence-based medicine. Where is the evidence that “the recurrence rate after old biliary surgery should be the residual rate”? Do we have accurate data on the standardized incidence rate of gallbladder cancer in China? Do the 100,000 people who are the base of the standardized incidence rate all have gallbladder disease and need to be removed?
Which physicians at which hospitals have removed the normal gallbladder to prevent gallbladder cancer? Which study concluded that there is an increased incidence of common bile duct stones after cholecystectomy? Is the formation of gallbladder stones really a sudden event? Can this academic thinking be the basis for drawing conclusions? The author does not intend to play a big game of words, but only to show that it is necessary to have an objective basis to support the academic viewpoint, otherwise it will be both unscientific and make a common sense mistake.
In fact, after understanding the core viewpoint and specific practice of biliary lithotripsy, the author believes that its starting point of focusing on the structural and functional protection of the gallbladder is consistent with the basic principles of medical activities and has its reasonable components under the present-day environment and requirements.
However, in the absence of evidence-based medical evidence, it is obvious that it is easy to question and controversial to compare the recent advantages shown by the treatment of a few thousand cases of biliary stone extraction with the accumulated problems of tens of millions of cholecystectomies practiced for more than a hundred years and then conclude that biliary stone extraction is superior to cholecystectomy and can replace cholecystectomy as the new standard of treatment for gallbladder stones.
Changes in medical principles have a guiding effect, not only on the treatment and survival of a large number of patients, but also on the training and growth of young physicians. As for the application of biliary lithotripsy, it may still be appropriate to carry out experimental treatment for research purposes only in a relatively small area, and to evaluate and conclude fully after appropriate evidence-based medical evidence is obtained.
It may not be consistent with medical principles to promote the method in its current form, because after all, objective evaluation of a therapeutic measure requires practice plus repeated testing over time, and the potential for misleading the public goes far beyond the scope of the medical activity itself.