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

Ahmed, Irfan; Hudson, Jemma; Innes, Karen; Hernández, Rodolfo; Gillies, Katie; Bruce, Rebecca; Bell, Victoria; Avenell, Alison; Blazeby, Jane; Brazzelli, Miriam; Cotton, Seonaidh; Croal, Bernard; Forrest, Mark; MacLennan, Graeme; Murchie, Peter; Wileman, Samantha; Ramsay, Craig

doi:10.1136/bmj-2023-075383

Cited by 9 publications

(1 citation statement)

References 41 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Despite previous findings, the surgical treatment of symptomatic gallstone remains controversial[ 6 , 18 ]. A young age is the main reason most pediatricians choose conservative treatment.…”

Section: Discussionmentioning

confidence: 99%

Follow-up study of gallbladder stones in 44 children

Yu,

Jiang,

Cai

et al. 2024

World J Clin Cases

View full text Add to dashboard Cite

BACKGROUND Cholesterol stones affect a certain subpopulation of children. Concerns have been raised on the impact of gallbladder surgery on the growth of children and adolescents. AIM To study the population characteristics, clinical features, treatment, and prognosis of gallstones in children. METHODS The clinical data of 44 children with gallstones admitted to The First Affiliated Hospital of Naval Medical University from August 2009 to August 2021 were collected, the children were followed up by telephone to monitor their prognoses. The follow-up ended in August 2023. The shortest follow-up time was 2 years and 6 months, whereas the longest was 13 years and 11 months. The population characteristics, general clinical characteristics, and treatments were retrospectively analyzed. The children were divided according to whether they underwent surgical gallbladder removal into an operation group (n = 28) and a non-operation group (n = 16), The effects of surgical gallbladder resection on the growth and development of children were analyzed. RESULTS The male–female ratio in the population was 6:5 and 84.09% of the children had onset in adolescence. Furthermore, 29.55% of the children were overweight or obese. The study identified 26 cases with metabolic abnormalities, 9 with hemolytic anemia, and 4 with choledochal cyst. Of the population, 68.18% had recurrent symptomatic cholecystolithiasis. Surgical treatment accounted for 63.64%, with laparoscopic cholecystectomy accounting for 71.43% of surgical treatment. No significant differences were observed in symptoms and complications between the surgery and non-surgery groups. Furthermore, no significant differences were found between the two groups in the attainment of genetic height target and the rightward shift of height curve during follow-up. CONCLUSION The sex characteristics of gallstones in children were not observed. Most gallstones occurred in adolescents and rarely in young children. A considerable proportion of children have inborn causes, which are often concurrent with metabolic abnormalities and hemolytic anemia. Most children had recurrent symptomatic gallstones. Surgical treatment, especially laparoscopic cholecystectomy, is still the main treatment for gallstones in children. Surgical treatment did not affect the growth and development of children who underwent gallstone removal.

show abstract

Section: Discussionmentioning

confidence: 99%

Follow-up study of gallbladder stones in 44 children

Yu,

Jiang,

Cai

et al. 2024

World J Clin Cases

View full text Add to dashboard Cite

show abstract

Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones

Comes,

Wennmacker,

Latenstein

et al. 2024

JAMA Surg

View full text Add to dashboard Cite

ImportanceThe 1-year results of the SECURE trial, a randomized trial comparing a restrictive strategy vs usual care for select patients with symptomatic cholelithiasis for cholecystectomy, resulted in a significantly lower operation rate after restrictive strategy. However, a restrictive strategy did not result in more pain-free patients at 1 year.ObjectiveTo gauge pain level and determine the proportion of pain-free patients, operation rate, and biliary and surgical complications at the 5-year follow-up.Design, Setting, and ParticipantsThis randomized clinical trial was a multicenter, parallel-arm, noninferiority, prospective study. Between February 2014 and April 2017, patients from 24 hospitals with symptomatic, uncomplicated cholelithiasis were included. Uncomplicated cholelithiasis was defined as gallstone disease without signs of complicated cholelithiasis, ie, biliary pancreatitis, cholangitis, common bile duct stones, or cholecystitis. Follow-up data for this analysis were collected by telephone from July 11, 2019, to September 23, 2023.InterventionsPatients were randomized (1:1) to receive usual care or a restrictive strategy with stepwise selection for cholecystectomy.Main Outcomes and MeasuresThe primary, noninferiority end point was proportion of patients who were pain free as evaluated by Izbicki pain score at the 5-year follow-up. A 5% noninferiority margin was chosen. The secondary end points included cholecystectomy rates, biliary and surgical complications, and patient satisfaction.ResultsAmong 1067 patients, the median (IQR) age was 49.0 years (38.0-59.0 years); 786 (73.7%) were female, and 281 (26.3%) were male. At the 5-year follow-up, 228 of 363 patients (62.8%) were pain free in the usual care group, compared with 216 of 353 patients (61.2%) in restrictive strategy group (difference, 1.6%; 1-sided 95% lower confidence limit, −7.6%; noninferiority P = .18). After cholecystectomy, 187 of 294 patients (63.6%) in the usual care group and 160 of 254 patients (63.0%) in the restrictive strategy group were pain free, respectively (P = .88). The restrictive care strategy was associated with 387 of 529 cholecystectomies (73.2%) compared with 437 of 536 in the usual care group (81.5%; 8.3% difference; P = .001). No differences between groups were observed in biliary and surgical complications or in patient satisfaction.Conclusions and RelevanceIn the long-term, a restrictive strategy results in a significant but small reduction in operation rate compared with usual care and is not associated with increased biliary and surgical complications. However, regardless of the strategy, only two-third of patients were pain free. Further criteria for selecting patients with uncomplicated cholelithiasis for cholecystectomy and rethinking laparoscopic cholecystectomy as treatment is needed to improve patient-reported outcomes.Trial RegistrationCCMO Identifier: NTR4022

show abstract

Not Time to Abandon Cholecystectomy for Symptomatic Cholelithiasis—Reply

Comes,

de Reuver

2024

JAMA Surg

View full text Add to dashboard Cite

COMMENT & RESPONSEIn Reply We thank Wehrle and colleagues for their comments and advocacy that routine cholecystectomy for gallstone disease should remain the standard of care, with nonoperative management being the exception. The conclusion from the long-term follow-up of the SECURE trial was that the restrictive strategy is as disappointing as usual care in achieving a pain-free state after cholecystectomy. 1 Additionally, treatment satisfaction and the rate of biliary and surgical complications between usual care and the restrictive strategy showed no significant difference. These results should not be interpreted as a reason to abandon cholecystectomy for symptomatic cholelithiasis, but rather as an opportunity to reconsider the indication when the a priori likelihood of achieving a pain-free state is low, surgical capacity is limited, and the burden of surgery is substantial. While the majority of surgically treated patients were operated on within 6 weeks, 26.3% of patients in the restrictive arm required no surgical treatment over a period of 5 years. 1 We agree that cholecystectomy is the definitive surgical solution for complicated cholecystolithiasis, but we argue that it is not the solution for all patients with abdominal pain in the presence of gallstones. The C-GALL trial reinforces that symptomatic cholecystolithiasis is not exclusively a surgical disease. 2 After 2 years of follow-up, only 25% of patients in the conservative arm required surgery. Importantly, at the end of followup, outcomes related to quality of life, abdominal pain, and biliary or surgical complications were similar between both groups. 2 Two recent randomized clinical trials clearly show that a restrictive strategy or even conservative management is safe and feasible, demonstrating that not all patients with symptomatic cholecystolithiasis require surgery. Irritable bowel syndrome and dyspepsia are common causes of persistent pain and should be excluded prior to surgery. 3 Second, the relationship between gallstones and metabolic syndrome highlights a broader, systemic issue that calls for a more holistic approach. Simply performing a cholecystectomy without addressing the underlying metabolic factors or functional disorders is short-sighted and can lead to suboptimal long-term outcomes. A more comprehensive management strategy, which considers lifestyle, dietary factors, and metabolic health, may be more effective in treating the root causes of symptomatic cholecystolithiasis and preventing other sequelae of metabolic syndrome.We acknowledge that it could be debated whether the Izbicki pain score, originally developed for pancreatitis, is the right instrument to evaluate persistent pain after surgery. However,

show abstract

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

Cited by 9 publications

References 41 publications

Follow-up study of gallbladder stones in 44 children

Follow-up study of gallbladder stones in 44 children

Restrictive Strategy vs Usual Care for Cholecystectomy in Patients With Abdominal Pain and Gallstones

Not Time to Abandon Cholecystectomy for Symptomatic Cholelithiasis—Reply

Contact Info

Product

Resources

About