Uncomplicated Symptomatic Gallstones Research Articles

Laparoscopic cholecystectomy versus conservative management for adults with uncomplicated symptomatic gallstones: the C-GALL RCT.

Gallstone disease is a common gastrointestinal disorder in industrialised societies. The prevalence of gallstones in the adult population is estimated to be approximately 10-15%, and around 80% remain asymptomatic. At present, cholecystectomy is the default option for people with symptomatic gallstone disease. To assess the clinical and cost-effectiveness of observation/conservative management compared with laparoscopic cholecystectomy for preventing recurrent symptoms and complications in adults presenting with uncomplicated symptomatic gallstones in secondary care. Parallel group, multicentre patient randomised superiority pragmatic trial with up to 24 months follow-up and embedded qualitative research. Within-trial cost-utility and 10-year Markov model analyses. Development of a core outcome set for uncomplicated symptomatic gallstone disease. Secondary care elective settings. Adults with symptomatic uncomplicated gallstone disease referred to a secondary care setting were considered for inclusion. Participants were randomised 1: 1 at clinic to receive either laparoscopic cholecystectomy or observation/conservative management. The primary outcome was quality of life measured by area under the curve over 18 months using the Short Form-36 bodily pain domain. Secondary outcomes included the Otago gallstones' condition-specific questionnaire, Short Form-36 domains (excluding bodily pain), area under the curve over 24 months for Short Form-36 bodily pain domain, persistent symptoms, complications and need for further treatment. No outcomes were blinded to allocation. Between August 2016 and November 2019, 434 participants were randomised (217 in each group) from 20 United Kingdom centres. By 24 months, 64 (29.5%) in the observation/conservative management group and 153 (70.5%) in the laparoscopic cholecystectomy group had received surgery, median time to surgery of 9.0 months (interquartile range, 5.6-15.0) and 4.7 months (interquartile range 2.6-7.9), respectively. At 18 months, the mean Short Form-36 norm-based bodily pain score was 49.4 (standard deviation 11.7) in the observation/conservative management group and 50.4 (standard deviation 11.6) in the laparoscopic cholecystectomy group. The mean area under the curve over 18 months was 46.8 for both groups with no difference: mean difference -0.0, 95% confidence interval (-1.7 to 1.7); p-value 0.996; n = 203 observation/conservative, n = 205 cholecystectomy. There was no evidence of differences in quality of life, complications or need for further treatment at up to 24 months follow-up. Condition-specific quality of life at 24 months favoured cholecystectomy: mean difference 9.0, 95% confidence interval (4.1 to 14.0), p < 0.001 with a similar pattern for the persistent symptoms score. Within-trial cost-utility analysis found observation/conservative management over 24 months was less costly than cholecystectomy (mean difference -£1033). A non-significant quality-adjusted life-year difference of -0.019 favouring cholecystectomy resulted in an incremental cost-effectiveness ratio of £55,235. The Markov model continued to favour observation/conservative management, but some scenarios reversed the findings due to uncertainties in longer-term quality of life. The core outcome set included 11 critically important outcomes from both patients and healthcare professionals. The results suggested that in the short term (up to 24 months) observation/conservative management may be a cost-effective use of National Health Service resources in selected patients, but subsequent surgeries in the randomised groups and differences in quality of life beyond 24 months could reverse this finding. Future research should focus on longer-term follow-up data and identification of the cohort of patients that should be routinely offered surgery. This trial is registered as ISRCTN55215960. This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: 14/192/71) and is published in full in Health Technology Assessment; Vol. 28, No. 26. See the NIHR Funding and Awards website for further award information.

Effectiveness of conservative management versus laparoscopic cholecystectomy in the prevention of recurrent symptoms and complications in adults with uncomplicated symptomatic gallstone disease (C-GALL trial): pragmatic, multicentre randomised controlled trial

ObjectiveTo assess the clinical and cost effectiveness of conservative management compared with laparoscopic cholecystectomy for the prevention of symptoms and complications in adults with uncomplicated symptomatic gallstone disease.DesignParallel group, pragmatic...

Medical Management of Uncomplicated Symptomatic Small Gallstones in Elderly

Medical Management of Uncomplicated Symptomatic Small Gallstones in Elderly

A mixed-methods study to define Textbook Outcome for the treatment of patients with uncomplicated symptomatic gallstone disease with hospital variation analyses in Dutch trial data

BackgroundInternational consensus on the ideal outcome for treatment of uncomplicated symptomatic gallstone disease is absent. This mixed-method study defined a Textbook Outcome (TO) for this large group of patients. MethodsFirst, expert meetings were organised with stakeholders to design the survey and identify possible outcomes. To reach consensus, results from expert meetings were converted in a survey for clinicians and for patients. During the final expert meeting, clinicians and patients discussed survey outcomes and a definitive TO was formulated. Subsequently, TO-rate and hospital variation were analysed in Dutch hospital data from patients with uncomplicated gallstone disease. ResultsFirst expert meetings returned 32 outcomes. Outcomes were distributed in a survey among 830 clinicians from 81 countries and 645 Dutch patients. Consensus-based TO was defined as no more biliary colic, no biliary and surgical complications, and the absence or reduction of abdominal pain. Analysis of individual patient data showed that TO was achieved in 64.2% (1002/1561). Adjusted-TO rates showed modest variation between hospitals (56.6-74.9%). ConclusionTO for treatment of uncomplicated gallstone disease was defined as no more biliary colic, no biliary and surgical complications, and absence or reduction of abdominal pain.TO may optimise consistent outcome reporting in care and guidelines for treating uncomplicated gallstone disease.

Cost-effectiveness of cholecystectomy compared to conservative management in people presenting with uncomplicated symptomatic gallstones or cholecystitis in India

Objectives Gallstone diseases impose a significant economic burden on the health care system; thus, determining cost-effective management for gallstones is essential. We aim to estimate the cost-effectiveness of cholecystectomy compared with conservative management in individuals with uncomplicated symptomatic gallstones or cholecystitis in India. Methods A decision-analytic Markov model was used to compare the costs and QALY of Early laparoscopic cholecystectomy (ELC), Delayed laparoscopic cholecystectomy (DLC) and Conservative Management (CM) in patients with symptomatic uncomplicated gallstone/cholecystitis from a Indian health system perspective. Incremental cost-effectiveness ratio (ICER) was calculated. One-way and probabilistic sensitivity analyses were performed to test parameter uncertainties. Results ELC and DLC, compared to CM, incurred an incremental cost of -₹10,948 ($146) and ₹1,054 ($14) for the 0.032 QALYs gained. The ICER was -₹3,42,758 ($4577) for ELC vs. CM, and ₹33,183 ($443) for DLC vs. CM, suggesting ELC and DLC is cost-effective. ELC saved ₹12,001 ($160) for 0.0002 QALYs gained compared to DLC, resulting in an ICER of -₹6,43,89,441 ($8,59,733). Results were robust to changes in the input parameters in sensitivity analyses. Conclusion ELC is dominant compared to both DLC and CM, and DLC is more cost-effective than CM. Thus, ELC may be preferable to other gallstone disease managements.

Cholecystectomy vs Conservative Management to Prevent Recurrent Symptoms/Complications in Adults with Uncomplicated Symptomatic Gallstones (C-GALL): A Multicentre RCT

Cholecystectomy vs Conservative Management to Prevent Recurrent Symptoms/Complications in Adults with Uncomplicated Symptomatic Gallstones (C-GALL): A Multicentre RCT

A Mixed-methods Study to Define Textbook Outcome for the Treatment of Patients with Uncomplicated Symptomatic Gallstone Disease with Dutch Hospital Variation Analyses

A Mixed-methods Study to Define Textbook Outcome for the Treatment of Patients with Uncomplicated Symptomatic Gallstone Disease with Dutch Hospital Variation Analyses

National clinical practice guidelines for the treatment of symptomatic gallstone disease: 2021 recommendations from the Danish Surgical Society.

Gallstones are highly prevalent, and more than 9000 cholecystectomies are performed annually in Denmark. The aim of this guideline was to improve the clinical course of patients with gallstone disease including a subgroup of high-risk patients. Outcomes included reduction of complications, readmissions, and need for additional interventions in patients with uncomplicated gallstone disease, acute cholecystitis, and common bile duct stones (CBDS). An interdisciplinary group of clinicians developed the guideline according to the GRADE methodology. Randomized controlled trials (RCTs) were primarily included. Non-RCTs were included if RCTs could not answer the clinical questions. Recommendations were strong or weak depending on effect estimates, quality of evidence, and patient preferences. For patients with acute cholecystitis, acute laparoscopic cholecystectomy is recommended (16 RCTs, strong recommendation). Gallbladder drainage may be used as an interval procedure before a delayed laparoscopic cholecystectomy in patients with temporary contraindications to surgery and severe acute cholecystitis (1 RCT and 1 non-RCT, weak recommendation). High-risk patients are suggested to undergo acute laparoscopic cholecystectomy instead of drainage (1 RCT and 1 non-RCT, weak recommendation). For patients with CBDS, a one-step procedure with simultaneous laparoscopic cholecystectomy and CBDS removal by laparoscopy or endoscopy is recommended (22 RCTs, strong recommendation). In high-risk patients with CBDS, laparoscopic cholecystectomy is suggested to be included in the treatment (6 RCTs, weak recommendation). For diagnosis of CBDS, the use of magnetic resonance imaging or endoscopic ultrasound prior to surgical treatment is recommended (8 RCTs, strong recommendation). For patients with uncomplicated symptomatic gallstone disease, observation is suggested as an alternative to laparoscopic cholecystectomy (2 RCTs, weak recommendation). Seven recommendations, four weak and three strong, for treating patients with symptomatic gallstone disease were developed. Studies for treatment of high-risk patients are few and more are needed. The Danish Surgical Society.

Core outcome set for symptomatic uncomplicated gallstone disease.

Heterogeneity of outcomes is a problem for assessing intervention effectiveness when considering treatments for uncomplicated symptomatic gallstone disease. The value to all stakeholders of outcomes that have been measured and reported to date is also unclear. The aim of this study was to develop a core outcome set for symptomatic uncomplicated gallstone disease. An in person-meeting was held with patients to prioritize potentially important outcomes from a previously developed longlist of outcomes. This was followed by an online three-round Delphi survey that was conducted with healthcare professionals. The results of each consensus process were compared and combined to produce the final core outcome set. A total of 82 participants enrolled in round 1 of the Delphi survey, with a final sample of 40 participants contributing to round 3. Five patients contributed to the in-person group meeting. Following the consensus processes, 11 outcomes were considered to be core by patients and healthcare professionals, and included in the core outcome set. These were: quality of life; overall health state; overall satisfaction; overall pain; common bile duct injury; biliary leak; haemorrhage; need for endoscopic retrograde cholangiopancreatography; intra-abdominal collections; admission/readmission for problems; and reoperation. A core outcome set for symptomatic uncomplicated gallstone disease has been developed with patients and healthcare professionals. Eleven outcomes across four key domains have been identified. These represent the minimum set of outcomes that should be reported in trials evaluating interventions for gallstone disease.

Identification and categorisation of relevant outcomes for symptomatic uncomplicated gallstone disease: in-depth analysis to inform the development of a core outcome set

BackgroundMany completed trials of interventions for uncomplicated gallstone disease are not as helpful as they could be due to lack of standardisation across studies, outcome definition, collection and reporting. This...

Indications of cholecystectomy in gallstone disease.

Recent studies showed new insights in the indication and timing of cholecystectomy in gallstone disease. This review will provide an overview. 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. 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.

Review of imaging in post-laparoscopy cholecystectomy complications.

Laparoscopic cholecystectomy is now considered the procedure of choice for uncomplicated symptomatic gallstone disease worldwide. Various biliary, vascular, gastrointestinal, neurological and local complications may be seen on imaging post surgery. Knowledge of these entities and imaging appearances is indispensable for the radiologist in today's era. We emphasize on the list of potential complications and imaging appearances of this surgical procedure.

Are routine preoperative liver function tests in patients with uncomplicated symptomatic gallstone disease necessary?

Background: The aim of this study was to evaluate the value of preoperative liver function tests (LFTs) in patients with uncomplicated gallstone disease and scheduled for laparoscopic cholecystectomy.Methods: All 1112 patients who underwent a laparoscopic cholecystectomy for symptomatic gallstone disease during a 6-year cohort were retrospectively reviewed. Only patients who presented with uncomplicated disease were selected. Preoperative LFTs, pre-, and postoperative endoscopic retrograde cholangio pancreaticographies (ERCPs) and postoperative complications were collected.Results: A total of 697 patients were included. There were 629 (90.2%) patients with (group I) and 68 (9.8%) patients without (group II) preoperative LFTs. The incidence of ERCPs, ERCPs positive for bile duct stones, and postoperative complications were not significantly different between groups. Second, Group I patients were divided into four groups: 360 patients with normal LFTs (I-A1), 269 patients with at least one LFT > normal value (I-A2), 531 patients with all LFTs <2× normal (I-B1), and 98 patients with at least one LFT >2× normal (I-B2). More ERCPs were performed in group I-A2 (10%) than in group I-A1 (2.2%) and more in group I-B2 (18.4%) than I-B1 (3.2%), as a consequence of significantly more ERCPs performed preoperatively. No differences were detected between groups regarding ERCPs positive for bile duct stones or postoperative complications.Conclusions: Preoperative LFTs do not influence the occurrence of postoperative complications nor the total rate of ERCPs in patients undergoing cholecystectomy for uncomplicated gallstone disease. Preoperative determination of LFTs seems to cause a slight shift from post- to preoperative ERCPs without further clinical consequences.

Systematic review of the clinical and cost effectiveness of cholecystectomy versus observation/conservative management for uncomplicated symptomatic gallstones or cholecystitis.

Gallstone disease is a common gastrointestinal disorder in industrialised countries. Although symptoms can be severe, some people can be symptom free for many years after the original attack. Surgery is the current treatment of choice, but evidence suggests that observation is also feasible and safe. We reviewed the evidence on cholecystectomy versus observation for uncomplicated symptomatic gallstones and conducted a cost-effectiveness analysis. We searched six electronic databases (last search April 2014). We included randomised controlled trials (RCTs) or non-randomised comparative studies where adults received either cholecystectomy or observation/conservative management for the first episode of symptomatic gallstone disease (biliary pain or cholecystitis) being considered for surgery in secondary care. Meta-analysis was used to combine results. A de novo Markov model was developed to assess the cost effectiveness of the interventions. Two RCTs (201 participants) were included. Eighty-eight percent of people randomised to surgery and 45 % of people randomised to observation underwent cholecystectomy during the 14-year follow-up period. Participants randomised to observation were significantly more likely to experience gallstone-related complications (RR = 6.69, 95 % CI = 1.57-28.51, p = 0.01), in particular acute cholecystitis (RR = 9.55, 95 % CI = 1.25-73.27, p = 0.03), and less likely to undergo surgery (RR = 0.50, 95 % CI = 0.34-0.73, p = 0.0004) or experience surgery-related complications (RR = 0.36, 95 % CI = 0.16-0.81, p = 0.01) than those randomised to surgery. Fifty-five percent of people randomised to observation did not require surgery, and 12 % of people randomised to cholecystectomy did not undergo surgery. On average, surgery costs £1,236 more per patient than conservative management, but was more effective. Cholecystectomy is the preferred treatment for symptomatic gallstones. However, approximately half the observation group did not require surgery or suffer complications indicating that it may be a valid alternative to surgery. A multicentre trial is needed to establish the effects, safety and cost effectiveness of observation/conservative management relative to cholecystectomy.

Minilaparotomy cholecystectomy with ultrasonic dissection versus conventional laparoscopic cholecystectomy: a randomized multicenter study

Objective. Cholecystectomy by minilaparotomy (MC) or by laparoscopy (LC) has been shown to have equal results of both early and late recovery. Although, the ultrasonic dissection (UsD) technique has seen used in LC, the technique is rarely used in MC. Material and methods. Initially, 88 patients with uncomplicated symptomatic gallstones were randomized into MC with UsD (n = 44) or conventional LC (n = 44) over a 2-year period (2010–2012). The two groups were similar in terms of age and American Society of Anesthesiologists (ASA) physical status score. Results. Both groups were similar in terms of the operative time and the time in the operation theatre, the success of day-surgery and satisfaction with the procedure. The MC group had significantly less postoperative pain than the LC group, p = 0.002, and the MC group used less analgesics doses during the first 24 h: 2.8 (1.2) doses vs. 3.8 (1.4) doses, p = 0.003. The convalescence needed was 3 days shorter in the MC group, 7 (3) days, than that in the LC-group, 10 (8) days, p = 0.024. In the MC group 4 patients and in the LC group 11 (p = 0.046) required more than 14 days of sick leave. In the MC group there was one and in the LC group two conversions to open surgery. Conclusion.The patients in the MC group had less early postoperative pain and had a shorter convalescence than the patients in the LC group.

Ten-year outcome after minilaparotomy versus laparoscopic cholecystectomy: a prospective randomised trial

Laparoscopic cholecystectomy (LC) and minilaparotomy cholecystectomy (MC) are the two most commonly performed mini-invasive surgical techniques for the treatment of symptomatic gallstone disease, but the long-term outcome after these two procedures has not been compared in prospective clinical trials. We therefore investigated the outcome after LC and MC in 127 patients operated at Kuopio University Hospital. Initially 157 patients with uncomplicated symptomatic gallstones were randomised to MC (n = 85) or LC (n = 72) over a 5-year period (1998-2004), and 127 of them (81 %), 69/85 with MC and 58/72 with LC, were reached for a follow-up interview 10.5 (7.3-13.6) years after the surgery. Baseline and surgical parameters were similar in the two groups; 3/69 MCs and 2/58 LCs were converted to open laparotomy. The prevalence of chronic post-surgical pain 10 years after procedure was similar in the two groups: 5/69 (7 %) in the MC group and 1/58 (2 %) in the LC group (p = 0.14). Residual abdominal symptoms were common, but less frequent in the MC group (14/69; 20 %) than in the LC group (21/58 patients; 36 %) (p = 0.039). In the MC group 63/69 (91 %) and 57/58 (98 %) in the LC group (p = 0.059) were satisfied with the cosmetic outcome. Our results suggest a relatively similar long-term outcome after MC and LC.

Ambulatory laparoscopic cholecystectomy: Is it safe and cost effective?

BACKGROUND:Laparoscopic cholecystectomy (LC) is the most commonly performed minimal invasive surgery. However, practice of its use as an ambulatory surgery in our hospital settings is uncommon.OBJECTIVE:To evaluate safety and cost effectiveness of LC as an ambulatory day care surgery.STUDY DESIGN:Quasiexperimental.SETTING:Department of surgery, Aga Khan University Hospital, Karachi, Pakistan.MATERIALS AND METHODS:Patients with uncomplicated symptomatic gallstones were selected for Ambulatory LC. They were admitted electively on the same day and operated on in the morning hours and discharged after a check by the surgeon 6–8 hrs later.RESULTS:Of fifty (n = 50) patients selected for ambulatory LC, 92% were discharged successfully after 6–8 hrs observation. No significant perioperative complications were noted. Unplanned admission and readmission rate was 8 and 2%, respectively. Cost saving for the daycare surgery was Rs. 6,200, Rs. 13,300, and Rs.22,800 per patient as compared to in patient general, semiprivate, and private ward package, respectively.CONCLUSION:Practice ambulatory LC is safe and cost-effective in selected patients with uncomplicated symptomatic gallstones.

Is Complicated Gallstone Disease Preceded by Biliary Colic?

IntroductionCholecystectomy in cases of “warning” episodes of biliary colic may prevent biliary pancreatitis. We aimed to determine which proportion of patients with biliary pancreatitis, compared to other complicated and uncomplicated symptomatic gallstone disease, experienced “warning” episodes of colic and why these episodes did not lead to early cholecystectomy. Patients and methodsOne hundred seventy-five patients with complicated gallstone disease [pancreatitis (n = 53), symptomatic common bile duct (CBD) stones (n = 64), and acute cholecystitis (n = 58)] and 175 patients with symptomatic uncomplicated gallstones were interviewed at admission. ResultsFifty-seven percent (100 of 175) of patients with complicated disease (95% confidence interval = 50–65%) experienced “warning” episodes of biliary colic (pancreatitis 58%, CBD stones 67%, cholecystitis 45%) vs 96% (164 of 175) in uncomplicated disease. Eighty-seven percent of patients with “warning” episodes and complicated disease experienced patient’s and general practitioner’s delays. General practitioner’s delay was more frequent if pain was located in the epigastric region compared to the right upper quadrant (51% vs 38%, P = 0.03). ConclusionsHalf of patients with biliary pancreatitis experience “warning” episodes of biliary colic, similar to other gallstone complications. In symptomatic patients, complications are often not prevented because of significant delays in diagnosis and treatment.

Association between gallstone-evoked pain, inflammation and proliferation of nerves in the gallbladder: A possible explanation for clinical differences

Objective. To investigate whether enhanced neuroproliferation could be involved in the pathogenesis of gallstone pain. Material and methods. Gallbladders from 117 patients with gallstones and 43 controls were examined. The gallbladder samples were immunostained against the pan-neuronal marker PGP 9.5 and the number of nerves and nerve area per tissue area estimated. Results. More nerves and an increased nerve area per tissue area were found in uncomplicated symptomatic gallstone disease. In comparison, acute cholecystitis displayed a significantly (p=0.01) decreased number of nerves and nerve area per tissue area. In both categories, the gallbladder neck contained more nerves (p=0.06 and 0.04, respectively) and an increased nerve area per tissue area (p=0.034 and 0.008, respectively) than the body. Conclusions. Uncomplicated disease showed enhanced neuroproliferation, significantly more in the gallbladder neck, whereas significantly fewer nerves were observed in acute cholecystitis. Nerve growth alteration may play a role in uncomplicated gallstone pain but the pathology may be different in inflammation.

Abdominal spilled stones: ultrasound findings

Laparoscopic cholecystectomy (LC) is the treatment of choice for uncomplicated symptomatic gallstones. Spillage of stones due to gallbladder rupture has been reported in up to 33% of all LCs, but clinical sequelae caused by dropped gallstones are uncommon. We recently observed two patients with retained stones after LC. Correct diagnosis was made by abdominal ultrasonography (US) in both cases. In the first patient, who presented with fever, malaise, and weight loss 18 months after LC, abdominal US revealed hypoechoic focal lesions containing hyperechoic images with posterior shadowing of the liver and spleen. US-guided aspiration biopsies of these lesions yielded purulent material, and the injection and aspiration of saline solution provoked rolling movements of the hyperechoic images. Laparotomy confirmed the diagnosis of abscess-containing spilled gallstones. In the second patient, multiple hyperechoic images with posterior shadowing were observed in the Morison pouch during a routine US examination. The diagnosis of retained stones was consistent with the history of gallstone spillage during LC performed 2 months previously and was confirmed by computed tomographic findings of hyperdense images in the Morison pouch. The patient was asymptomatic, and treatment was thus deferred. Our experience suggests that US can be very useful in the detection of gallstones spilled during LC.