Therapy of Asymptomatic Cholecystolithiasis
After diagnosing asymptomatic cholecystolithiasis, the risk of developing symptoms is 2-4% per year in the first 5 years and then halves. The risk of biliary complications is only 0.1-0.3% per year [1]. Prophylactic cholecystectomy does not increase life expectancy in asymptomatic stone carriers, as the surgical risk outweighs the likelihood of developing biliary complications [2]. Various guidelines agree that asymptomatic cholecystolithiasis generally does not constitute an indication for surgery [3, 4, 5].
A special case involves asymptomatic stone carriers with gallbladder stones > 3 cm. According to the German S3 guideline 2017, cholecystectomy should be considered in these cases, as the risk of developing gallbladder carcinoma is up to ten times higher [6].
Recommendation for Asymptomatic Stone Carriers in the Context of Obesity Surgery
The German S3 guideline 2017 recommends performing cholecystectomy only in symptomatic stone carriers in the context of obesity surgery [4]. The EASL guidelines 2016 agree with the S3 guideline in this regard, although at a very low evidence level [5]. This is reflected in the S3 guideline in a second statement on this topic, according to which simultaneous cholecystectomy can be performed in larger malabsorptive procedures on the small intestine in asymptomatic patients.
Compared to sleeve resection and gastric banding, laparoscopic Roux-en-Y reconstruction has the highest risk for postoperative gallstone formation [7]. The recommendation that simultaneous cholecystectomy should only be performed in symptomatic stone carriers is reflected in a registry study and a meta-analysis [8, 9]. The likelihood of secondary cholecystectomy was low at 6.8% after laparoscopic Roux-en-Y reconstruction, and in 5.3% of cases, it was due to symptomatic cholecystolithiasis. Secondary cholecystectomy was almost always (95.5%) performed laparoscopically with very low morbidity (1.8%).
Therapy of Symptomatic Cholecystolithiasis
There is a consensus among all professional societies regarding the therapy of symptomatic cholecystolithiasis. The German S3 guideline 2017 recommends cholecystectomy for uncomplicated cholecystolithiasis with typical biliary pain [4].
The goal of cholecystectomy is to prevent recurrent biliary symptoms and later complications, as well as to prevent gallbladder carcinoma. Untreated patients develop colic again in about 70% of cases within the next 2 years, and 4% require acute cholecystectomy [10]. The risk of biliary complications is 1-3% per year. If the patient is symptom-free for 5 years, they are considered an asymptomatic stone carrier again and do not need cholecystectomy [11]. For gallbladder sludge, the German S3 guideline recommends the same approach as for symptomatic cholecystolithiasis [4]. Conservative-medical therapy or lithotripsy is now obsolete [3].
Antibiotic Prophylaxis in Elective Cholecystectomy
All the aforementioned guidelines agree that prophylactic antibiotic administration is not necessary during elective cholecystectomy in low-risk patients. There is no prospective, randomized study with sufficiently large patient numbers to clarify the question, but several meta-analyses, registry data from Germany and Sweden, and a Cochrane review exist [12, 13].
The SAGES guidelines make the same statement for low-risk patients and elaborate further [14]:
- In high-risk patients (age > 60 years, diabetics, gallstone colic within the last 30 days before surgery, jaundice, cholangitis, or acute cholecystitis), antibiotic administration can reduce the rate of wound infections.
- If antibiotic prophylaxis is administered, it should be given 1 hour before skin incision.
- In open cholecystectomy or conversion from laparoscopic to open procedure, the wound infection rate can be reduced from 15% to 6% [13].
Recommendation for Porcelain Gallbladder
The risk of developing gallbladder carcinoma in calcified gallbladders was previously stated to be up to 62%. Recent studies suggest this figure is too high [15, 16]. Nevertheless, prophylactic cholecystectomy is recommended for asymptomatic patients with porcelain gallbladder [4, 5, 14].
Recommendation for the Treatment of Gallbladder Polyps
The incidence of gallbladder polyps in Germany is about 6% [17]. The frequency of adenomas in these patients is about 5%. Adenomas > 1 cm in size contain carcinoma in up to 50% of cases, so these patients should be prophylactically cholecystectomized [18]. In even larger adenomas (1.8-2 cm), the incidence of carcinoma increases further, so from an oncological perspective, primary open cholecystectomy should be performed [19].
Gallbladder polyps < 1 cm in size have a significantly lower risk of malignancy, so immediate cholecystectomy is not necessary, but patients must be regularly monitored sonographically [19]. If patients develop biliary symptoms or additional risk factors (age > 50 years, solitary polyps, gallstones, rapidly growing polyps), surgery is indicated [18, 20].
Endosonography is superior to transcutaneous sonography for diagnosing gallbladder polyps (87–97% versus 52–76%) [21].
The SAGES guidelines from 2010 recommend laparoscopic cholecystectomy for treating gallbladder polyps in patients with large, solitary polyps or accompanying symptoms. A "wait-and-watch strategy" is recommended for patients with small polyps (< 5 mm) [14].
The EASL guidelines from 2016 elaborate further [5]:
- Cholecystectomy in patients with gallbladder polyps > 1 cm regardless of symptoms and independent of the presence of gallstones
- Cholecystectomy in patients with primary sclerosing cholangitis and gallbladder polyps
- No cholecystectomy for asymptomatic cholecystolithiasis and small polyps (< 5 mm)
The German S3 guideline recommends cholecystectomy only in patients with cholecystolithiasis and gallbladder polyps ≥ 1 cm regardless of symptoms [4].
Recommendation for Laparoscopy in Liver Cirrhosis Child-Pugh A and B
Patients with liver cirrhosis are predisposed to developing cholecystolithiasis. For laparoscopic cholecystectomy in Child-Pugh A and B patients, studies have shown acceptable morbidity (9.5-23%) and mortality (0-6.3%). A prospective randomized study demonstrated the superiority of the laparoscopic technique over the open one [22]. Laparoscopic cholecystectomy is not recommended for Child-Pugh C patients.
The aforementioned guidelines agree on this with varying levels of evidence and recommendation grades.
Recommendations for the Treatment of Acute Cholecystitis
The most common complication of cholecystolithiasis is acute cholecystitis, which in > 90% of cases is caused by a transient or permanent obstruction by stones in the cystic duct. Standardly, laparoscopic cholecystectomy is performed in these cases.
The recommendations of various guidelines for the optimal timing of cholecystectomy after diagnosing acute cholecystitis are as follows:
- German S3 guideline [4]
Acute cholecystitis is an indication for early laparoscopic cholecystectomy. This should be performed within 24 hours of hospital admission.
- EASL [5]
Early cholecystectomy (preferably within 72 hours of admission) should be performed by an experienced surgeon.
- SAGES [14]
Early cholecystectomy (within 24–72 hours of diagnosis) can be performed without an increased conversion rate to open surgery and without increased complication risk, and can reduce hospital costs and length of stay.
- Tokyo [23]
Determination of the treatment strategy after assessing the severity of acute cholecystitis. For both Grade I (mild) and II (moderate), laparoscopic cholecystectomy should ideally be performed soon after symptom onset if the patient can tolerate surgery. In cases of severe inflammation (Grade III), initial stabilization of organ function should be aimed for.
The Tokyo Guidelines from 2013 have been criticized by many professional societies as too conservative and outdated [24,25]. Based on current literature, immediate cholecystectomy within 24–48 hours is associated with clear patient benefits, which is withheld from Grade II patients according to the Tokyo Guidelines 2013 treatment recommendations.
Recommendation for Gallbladder Carcinoma, Carcinoma in situ (Tis), and Mucosal Carcinoma (T1a)
Incidental gallbladder carcinomas are found in less than 1% of cholecystectomy specimens. The T-stage is crucial for further therapy, which is why the German S3 guideline, in agreement with the SAGES guidelines, states that removal of the gallbladder is sufficient for carcinoma in situ (Tis) or mucosal carcinoma (T1a) [5, 14].
In the aforementioned early tumor stages, there is neither lymphatic nor perineural spread [26]. Therefore, liver resection or lymphadenectomy is not indicated. For all tumor stages ≥ T1b, oncological re-resection should be performed with a curative approach (wedge resection with 2-3 cm liver margin resection). Achieving an R0 status yields very good results after 4 years [26].
Recommendation for Laparoscopic Cholecystectomy in Pregnancy
Gallstones and sludge form in about 5% of all pregnant women, with about 1% experiencing gallstone-associated complications during pregnancy [27]. If managed conservatively, 92% of patients experience recurrent symptoms in the first trimester, 64% in the second trimester, and 44% in the third trimester. Fetal mortality due to biliary complications is 12-60%, significantly higher than due to indicated laparoscopic cholecystectomy (1.2%). Current studies show no significant differences in fetal mortality or preterm birth rates between open or laparoscopic cholecystectomy (5% vs. 4%) [28].
The German S3 guideline recommends that laparoscopic cholecystectomy during pregnancy can be performed in any trimester if urgently indicated. Furthermore, patients who become symptomatic in the first trimester should be operated on early electively due to the significant risk of recurrence later in pregnancy [5].
This statement is confirmed by the SAGES guidelines on the diagnosis, treatment, and use of laparoscopy during pregnancy:
- For acute abdominal processes, diagnostic laparoscopy is a safe and effective option even during pregnancy.
- Laparoscopic cholecystectomy is the treatment of choice for pregnant patients with gallstone diseases regardless of trimester.
- The same indications for laparoscopic treatment of acute abdominal diseases apply to pregnant patients as to non-pregnant patients.
- Laparoscopy can be safely performed in any trimester.
Recommendation for Access Techniques in Laparoscopic Cholecystectomy
Laparoscopic surgery is generally the standard procedure for cholecystectomy. Both the German S3 guideline and the EASL and SAGES guidelines make recommendations for the type of laparoscopic access. While the SAGES guideline makes rather vague statements, the S3 and EASL guidelines are specific, stating that laparoscopic cholecystectomy should be performed using a 4-trocar technique [4, 5, 14].
Currently, there are no large, randomized studies demonstrating an advantage for single-incision (SILS) or natural orifice transluminal endoscopic surgery (NOTES), so these techniques cannot currently be recommended as standard. Operating time and complication rates depend heavily on the surgeon's experience, and postoperative pain is not significantly reduced by either the SILS technique or the NOTES procedure [29, 30].