Transabdominal ultrasound and endoscopic ultrasound for diagnosis of gallbladder polyps.

BACKGROUND: Approximately 0.6% to 4% of cholecystectomies are performed because of gallbladder polyps. The decision to perform cholecystectomy is based on presence of gallbladder polyp(s) on transabdominal ultrasound (TAUS) or endoscopic ultrasound (EUS), or both. These polyps are currently considered for surgery if they grow more than 1 cm. However, non-neoplastic polyps (pseudo polyps) do not need surgery, even when they are larger than 1 cm. True polyps are neoplastic, either benign (adenomas) or (pre)malignant (dysplastic polyps/carcinomas). True polyps need surgery, especially if they are premalignant or malignant. There has been no systematic review and meta-analysis on the accuracy of TAUS and EUS in the diagnosis of gallbladder polyps, true gallbladder polyps, and (pre)malignant polyps. OBJECTIVES: To summarise and compare the accuracy of transabdominal ultrasound (TAUS) and endoscopic ultrasound (EUS) for the detection of gallbladder polyps, for differentiating between true and pseudo gallbladder polyps, and for differentiating between dysplastic polyps/carcinomas and adenomas/pseudo polyps of the gallbladder in adults. SEARCH METHODS: We searched the Cochrane Library, MEDLINE, Embase, Science Citation Index Expanded, and trial registrations (last date of search 09 July 2018). We had no restrictions regarding language, publication status, or prospective or retrospective nature of the studies. SELECTION CRITERIA: Studies reporting on the diagnostic accuracy data (true positive, false positive, false negative and true negative) of the index test (TAUS or EUS or both) for detection of gallbladder polyps, differentiation between true and pseudo polyps, or differentiation between dysplastic polyps/carcinomas and adenomas/pseudo polyps. We only accepted histopathology after cholecystectomy as the reference standard, except for studies on diagnosis of gallbladder polyp. For the latter studies, we also accepted repeated imaging up to six months by TAUS or EUS as the reference standard. DATA COLLECTION AND ANALYSIS: Two authors independently screened abstracts, selected studies for inclusion, and collected data from each study. The quality of the studies was evaluated using the QUADAS-2 tool. The bivariate random-effects model was used to obtain summary estimates of sensitivity and specificity, to compare diagnostic performance of the index tests, and to assess heterogeneity. MAIN RESULTS: A total of 16 studies were included. All studies reported on TAUS and EUS as separate tests and not as a combination of tests. All studies were at high or unclear risk of bias, ten studies had high applicability concerns in participant selection (because of inappropriate participant exclusions) or reference standards (because of lack of follow-up for non-operated polyps), and three studies had unclear applicability concerns in participant selection (because of high prevalence of gallbladder polyps) or index tests (because of lack of details on ultrasound equipment and performance). A meta-analysis directly comparing results of TAUS and EUS in the same population could not be performed because only limited studies executed both tests in the same participants. Therefore, the results below were obtained only from indirect test comparisons. There was significant heterogeneity amongst all comparisons (target conditions) on TAUS and amongst studies on EUS for differentiating true and pseudo polyps.Detection of gallbladder polyps: Six studies (16,260 participants) used TAUS. We found no studies on EUS. The summary sensitivity and specificity of TAUS for the detection of gallbladder polyps was 0.84 (95% CI 0.59 to 0.95) and 0.96 (95% CI 0.92 to 0.98), respectively. In a cohort of 1000 people, with a 6.4% prevalence of gallbladder polyps, this would result in 37 overdiagnosed and seven missed gallbladder polyps.Differentiation between true polyp and pseudo gallbladder polyp: Six studies (1078 participants) used TAUS; the summary sensitivity was 0.68 (95% CI 0.44 to 0.85) and the summary specificity was 0.79 (95% CI 0.57 to 0.91). Three studies (209 participants) used EUS; the summary sensitivity was 0.85 (95% CI 0.46 to 0.97) and the summary specificity was 0.90 (95% CI 0.78 to 0.96). In a cohort of 1000 participants with gallbladder polyps, with 10% having true polyps, this would result in 189 overdiagnosed and 32 missed true polyps by TAUS, and 90 overdiagnosed and 15 missed true polyps by EUS. There was no evidence of a difference between the diagnostic accuracy of TAUS and EUS (relative sensitivity 1.06, P = 0.70, relative specificity 1.15, P = 0.12).Differentiation between dysplastic polyps/carcinomas and adenomas/pseudo polyps of the gallbladder: Four studies (1,009 participants) used TAUS; the summary sensitivity was 0.79 (95% CI 0.62 to 0.90) and the summary specificity was 0.89 (95% CI 0.68 to 0.97). Three studies (351 participants) used EUS; the summary sensitivity was 0.86 (95% CI 0.76 to 0.92) and the summary specificity was 0.92 (95% CI 0.85 to 0.95). In a cohort of 1000 participants with gallbladder polyps, with 5% having a dysplastic polyp/carcinoma, this would result in 105 overdiagnosed and 11 missed dysplastic polyps/carcinomas by TAUS and 76 overdiagnosed and seven missed dysplastic polyps/carcinomas by EUS. There was no evidence of a difference between the diagnostic accuracy of TAUS and EUS (log likelihood test P = 0.74). AUTHORS' CONCLUSIONS: Although TAUS seems quite good at discriminating between gallbladder polyps and no polyps, it is less accurate in detecting whether the polyp is a true or pseudo polyp and dysplastic polyp/carcinoma or adenoma/pseudo polyp. In practice, this would lead to both unnecessary surgeries for pseudo polyps and missed cases of true polyps, dysplastic polyps, and carcinomas. There was insufficient evidence that EUS is better compared to TAUS in differentiating between true and pseudo polyps and between dysplastic polyps/carcinomas and adenomas/pseudo polyps. The conclusions are based on heterogeneous studies with unclear criteria for diagnosis of the target conditions and studies at high or unclear risk of bias. Therefore, results should be interpreted with caution. Further studies of high methodological quality, with clearly stated criteria for diagnosis of gallbladder polyps, true polyps, and dysplastic polyps/carcinomas are needed to accurately determine diagnostic accuracy of EUS and TAUS.

Indications of cholecystectomy in gallstone disease.

PURPOSE OF REVIEW: Recent studies showed new insights in the indication and timing of cholecystectomy in gallstone disease. This review will provide an overview. RECENT FINDINGS: Considerable variations in indication for gallbladder surgery have been noticed leading to a significant number of unnecessary cholecystectomies. As a consequence, up to 33% of patients with uncomplicated symptomatic gallstone disease have persistent abdominal pain after cholecystectomy. On the other hand, studies showed that certain patients with acute cholecystitis, common bile duct stones and biliary pancreatitis benefit from same admission instead of delayed cholecystectomy. SUMMARY: A critical view on indications for cholecystectomy in patients with uncomplicated symptomatic gallstone disease prevents unnecessary cholecystectomies. In patients with mild-to-moderate complicated symptomatic gallstone disease, same-admission cholecystectomy reduces the risk of recurrent complications.

Cost-effectiveness of a new strategy to identify uncomplicated gallstone disease patients that will benefit from a cholecystectomy.

BACKGROUND: The aim of this study was to determine the cost-effectiveness of a new strategy for the preoperative detection of patients that will likely benefit from a cholecystectomy, using simple criteria that can be applied by surgeons. Criteria for a cholecystectomy indication are: (1) having episodic pain; (2) onset of pain 1 year or less before the outpatient clinic visit. METHODS: The cost-effectiveness of the new strategy was evaluated against current practice using a decision analytic model. The incremental cost-effectiveness of applying criteria for a cholecystectomy for a patient with abdominal pain and gallstones was compared to applying no criteria. The incremental cost-effectiveness ratio (ICER) was expressed as extra costs to be invested to gain one more patient with absence of pain. Scenarios were analyzed to assess the influence of applying different criteria. RESULTS: The new strategy of applying one out of two criteria resulted in a 4 % higher mean proportion of patients with absence of pain compared to current practice with similar costs. The 95 % upper limit of the ICER was €4114 ($4633) per extra patient with relief of upper abdominal pain. Application of two out of two criteria resulted in a 3 % lower mean proportion of patients with absence of pain with lower costs. CONCLUSION: The new strategy of using one out of two strict selection criteria may be an effective but also a cost-effective method to reduce the proportion of patients with pain after cholecystectomy.

Episodic Abdominal Pain Characteristics Are Not Associated with Clinically Relevant Improvement of Health Status After Cholecystectomy.

BACKGROUND: Cholecystectomy is the therapy of first choice in patients with uncomplicated symptomatic cholecystolithiasis, but it remains unclear which patients truly benefit in terms of health status improvement. Patients generally present with episodic abdominal pain of varying frequency, duration, and intensity. We assessed whether characteristics of abdominal pain episodes are determinants of clinically relevant improvement of health status after cholecystectomy. METHODS: In a post hoc analysis of a prospective multicenter cohort study, patients of ≥18 years of age with uncomplicated symptomatic cholecystolithiasis subjected to cholecystectomy were included. Preoperatively, patients received a structured interview and a questionnaire consisting of the visual analogue scale (VAS; range 0-100) and gastrointestinal quality of life index (GIQLI). At 12 weeks after cholecystectomy, the GIQLI was again administered. Logistic regression analyses were performed to determine significant associations. RESULTS: Questionnaires were sent to 261 and returned by 166 (63.6 %) patients (128 females, mean age at surgery 49.5 ± 13.8). A total of 131 (78.9 %) patients reported a clinically relevant improvement of health status. The median (interquartile range) frequency, duration, and intensity of abdominal pain episodes were 0.38 (0.18-0.75) a week, 4.00 (2.00-8.00) hours, and 92 (77-99), respectively. None of the characteristics was associated with a clinically relevant improvement of health status at 12 weeks after cholecystectomy. CONCLUSIONS: Characteristics of abdominal pain episodes cannot be used to inform patients with symptomatic cholecystolithiasis who are skeptic about the timing of cholecystectomy for optimal benefit. Timing of cholecystectomy should therefore be based on other characteristics and preferences.

Value of EGD in patients referred for cholecystectomy: a systematic review and meta-analysis.

BACKGROUND: As many as 33% of patients with symptomatic cholelithiasis report persisting abdominal pain after cholecystectomy, suggesting alternative causes of these symptoms. EGD may serve as a tool to identify additional symptomatic abdominal disorders beforehand to avoid unnecessary gallbladder surgery. There is controversy as to whether routine EGD before cholecystectomy is appropriate. OBJECTIVE: To perform a systematic review and meta-analysis to assess the value of EGD before cholecystectomy. DESIGN: A systematic literature search was conducted to identify studies that reported the proportion of patients who were referred for cholecystectomy, but in whom initial surgery could be avoided after treatment of abnormalities detected with EGD. Pooled estimates with 95% confidence intervals (CIs) were calculated by using random-effects models. SETTING: Meta-analysis of 12 cohort studies. PATIENTS: A total of 6317 patients with cholelithiasis underwent EGD. RESULTS: The pooled estimate of abnormalities detected with EGD was 36.3% (95% CI, 28.0-45.0). In a total of 3.8% (95% CI, 1.4-7.6) of patients referred for cholecystectomy who underwent previous EGD, gallbladder surgery was avoided. LIMITATIONS: Lack of information regarding characteristics of patients referred for cholecystectomy, criteria for performing EGD, algorithms for the treatment of identified pathologies, and response criteria for the decision to avoid cholecystectomy in included studies. CONCLUSIONS: Our study indicates that, despite the high diagnostic yield of EGD, its value as a tool to prevent gallbladder surgery is limited. EGD should only be considered selectively in patients with cholelithiasis referred for cholecystectomy.

Patient-reported outcomes of symptomatic cholelithiasis patients following cholecystectomy after at least 5 years of follow-up: a long-term prospective cohort study.

BACKGROUND: Up to 41% of patients report pain after cholecystectomy and in most studies follow-up for these symptoms did not exceed 5 years. The episodic nature of abdominal pain associated with symptomatic cholelithiasis warrants long-term follow-up studies. We assessed which patient and surgical factors were associated with absence of pain and patient-reported success of surgery after ≥ 5 years of follow-up. METHODS: Patients of ≥ 18 years of age with symptomatic cholelithiasis, classified as ASA I or II, who had previously returned a preoperative questionnaire were sent a questionnaire consisting of the gastrointestinal quality of life index (GIQLI) and patient ratings of current versus presurgical abdominal symptoms and of surgery result. Logistic regression analysis was performed to determine associations. RESULTS: Questionnaires were sent to 197 patients and returned by 126 (64.0%) patients (73.8 % female, mean age at surgery 47.5 ± 12.2 years) at a mean of 10.0 ± 1.0 years after cholecystectomy. Absence of abdominal pain was reported by 60.3% of the patients. Patients classified as ASA II as opposed to ASA I were less likely to report absence of pain (OR 0.41, 95% CI 0.17-0.99). A positive rating of long-term postsurgical versus presurgical abdominal symptoms was given by 89.7% of the patients and 90.5% considered the cholecystectomy result to be good. No variables were significantly associated with these latter two outcome measures. CONCLUSIONS: We found a high patient-reported surgery success rate after >5 years of follow-up after cholecystectomy despite residual abdominal pain in some of these patients. None of the patient and surgery-related characteristics were consistently associated with all three outcome measures. This discrepancy between patient' outcomes highlights the need for realistic expectations prior to cholecystectomy.

[Outcome of treatment reported by patients: instrument to reduce variations in clinical practice]. / Uitkomst van behandeling volgens patiënten.

The frequency of certain medical procedures and their results vary strongly between countries, and also between regions within one country. These variations in clinical practice mean the quality of healthcare is suboptimal, result in unnecessary expense and patients are at risk of complications caused by unnecessary interventions. Patient Reported Outcome Measures (PROMs) are an instrument to clarify if a patient has benefited from a certain treatment. Systematic measurement of PROMs is necessary to show relevant differences in the effect of a therapy. If data of differences in results are combined with those of regional variations in clinical practice, it will become clear where too much or too less is treated. We expect that the systematic measurement of PROMs will make a valuable contribution to improving the quality of Dutch healthcare.

Persistent and de novo symptoms after cholecystectomy: a systematic review of cholecystectomy effectiveness.

BACKGROUND: Cholecystectomy is the preferred treatment option for symptomatic gallstones, but the exact relationship between cholecystectomies and symptoms still is unclear. This study aimed to assess the effectiveness of elective cholecystectomy for patients with cholecystolithiasis in terms of both persistent and de novo symptoms. METHODS: A systematic literature search was conducted in Pubmed and Embase. The search included studies comprising patients 18 years of age or older undergoing elective cholecystectomy for symptomatic cholecystolithiasis. The proportions of symptoms after cholecystectomy were calculated and then subdivided into persistent and de novo symptoms. RESULTS: A total of 38 studies reported the presence of postcholecystectomy symptoms. The results showed that upper abdominal pain, the main indication for cholecystectomy in the majority of the patients, mostly disappeared after surgery. However, it persisted in up to 33 % of the patients and arose de novo in up to 14 %. Diarrhea (85 %) and constipation (76 %) were the persistent symptoms most often reported, whereas upper abdominal pain and vomiting were the least often reported. Flatulence (62 %) was the most often reported new symptom. However, large variations in symptoms were found between studies. CONCLUSIONS: The review indicates that cholecystectomy often is ineffective with regard to persistent and de novo symptoms. The finding that the types and proportions of persistent symptoms differ from those that arise de novo suggests that this distinction may be useful in predicting which patients would and which would not benefit from a cholecystectomy.

Polymorphisms in gene encoding TRPV1-receptor involved in pain perception are unrelated to chronic pancreatitis.

BACKGROUND: The major clinical feature in chronic pancreatitis is pain, but the genetic basis of pancreatic pain in chronic pancreatitis is poorly understood. The transient receptor potential vanilloid receptor 1 (TRPV1) gene has been associated with pain perception, and genetic variations in TRPV1 may modify the presence and phenotype of chronic pancreatitis. The aim of our study was to investigate the genetic variation of TRPV1 in Dutch patients with chronic pancreatitis and healthy controls. METHODS: We genotyped 4 SNPs (rs222749, rs222747, rs224534 and rs8065080) in 228 chronic pancreatitis-patients and 207 healthy controls by PCR, followed by restriction-fragment-length-polymorphism analysis and DNA sequencing. We generated 27 diplotypes and compared prevalence between patients and controls. RESULTS: There was no significant difference in allele frequency of the 4 TRPV1 gene SNPs in patients with chronic pancreatitis and healthy controls. Distribution of diplotypes was not statistically significantly different between patients and controls. CONCLUSION: TRPV1 diplotypes are not associated with chronic pancreatitis.