Gallstone Disease: Common Questions and Answers.

In the United States, 10% to 15% of adults are affected by gallstones, and cholesterol gallstones are the most prevalent subtype. Risk factors for developing gallstone disease include female sex; older age; certain medications; and having type 2 diabetes mellitus, nonalcoholic fatty liver disease, obesity, rapid weight loss, or hemolytic anemia. Nearly 80% of gallstones are found incidentally and remain asymptomatic. When symptomatic, gallstone disease usually presents as sudden onset right upper quadrant or epigastric abdominal pain. Common complications of gallstones include cholecystitis, choledocholithiasis, gallstone pancreatitis, and ascending cholangitis. The Murphy sign is a specific physical examination finding for acute cholecystitis. Ultrasonography is the initial imaging choice for detecting gallstones and acute cholecystitis. A hepatobiliary iminodiacetic acid (HIDA) scan can be used to evaluate for cholecystitis in patients with negative or equivocal ultrasound findings. Magnetic resonance cholangiopancreatography (MRCP) is an accurate, noninvasive diagnostic test to identify choledocholithiasis, certain malignancies, and biliary obstruction. Nonsteroidal anti-inflammatory drugs are safe and effective in treating pain from acute cholecystitis and biliary colic. Laparoscopic cholecystectomy is the treatment of choice for most patients with biliary colic or acute cholecystitis. Ursodeoxycholic acid and chenodeoxycholic acid should not routinely be used to treat gallstone disease, but they can be used as a nonsurgical alternative for certain patients. Postcholecystectomy syndrome is a potential postoperative complication that presents with abdominal pain, bloating, and diarrhea. (Am Fam Physician. 2024;109(6):518-524.

Acute pancreatitis: A narrative review.

Acute pancreatitis is a common cause of acute abdominal pain and can range from mild oedema to severe necrosis of the pancreas. It has a significant impact on morbidity, mortality and financial burden. The global prevalence of pancreatitis is substantial, with the highest rates observed in central and eastern Europe. Diagnosing acute pancreatitis involves considering clinical symptoms, elevated serum amylase and/or lipase levels, and characteristic imaging findings. The causes of acute pancreatitis include obstructive disorders, such as gallstones and biliary sludge, alcohol consumption, smoking, drug-induced pancreatitis, metabolic disorders, trauma, medical procedures, infections, vascular diseases and autoimmune pancreatitis. Appropriate management of acute pancreatitis involves determining the severity of the condition, providing supportive care, addressing the underlying cause, and preventing complications. Advances in classifying the severity of acute pancreatitis and implementing goal-directed therapy have contributed to a decrease in mortality rates. Understanding its prevalence, aetiology and management principles is crucial for clinicians to appropriately diagnose and manage patients with acute pancreatitis.

Multi-institutional Retrospective Study of Percutaneous Cholangioscopy-Assisted Lithotripsy for Inoperable Calculous Cholecystitis.

PURPOSE: This study aimed to assess the safety and efficacy of percutaneous lithotripsy for gallstone eradication in patients with calculous cholecystitis with stones >1 cm. MATERIALS AND METHODS: Multi-institutional institutional review board approved retrospective review of patients who presented with calculous cholecystitis and were not determined to be surgical candidates. All patients underwent percutaneous cholecystostomy tube placement for acute infection, which was later exchanged for a large sheath for ShockPulse (Olympus, Tokyo, Japan) lithotripsy and stone destruction. Review parameters included procedural technical and clinical data, including clinical presentation, mean length of hospital stay, and postintervention symptom reduction. RESULTS: Twelve patients (mean age, 74.6 years; range, 52-94 years; 6 men and 6 women) underwent large-bore sheath (24-30 F) cholangioscopy-assisted gallstone destruction via rigid lithotripsy. The size of the gallstones ranged from 1.2 to 4.0 cm. All patients had prior cholecystostomy access for a mean of 25 weeks before gallstone extraction to ensure tract maturation via transhepatic or transperitoneal access. The technical success rate in single-session stone removal was 100%, with no major procedure-related adverse events. All patients were symptom- and pain-free after the procedure. The mean procedure time was 111.5 minutes, and the mean fluoroscopy time was 19.2 minutes. The median length of hospital stay was 1 day after the procedure. The mean time from percutaneous lithotripsy to biliary tube removal was 35 days (range, 17-45 days). CONCLUSIONS: Fluoroscopy-guided percutaneous rigid lithotripsy is a safe and effective procedure for gallstone destruction and extraction in patients who are poor surgical candidates with large lumen-occupying cholelithiasis.

Clinical characteristics, treatments, and outcomes of difficult biliary stones in a reference hospital in Colombia.

The local experience and the success rate of different available treatments for difficult biliary stones in Colombia are poorly described. We made an observational study reporting patients treated for difficult biliary stones, at Hospital Universitario San Ignacio in Bogotá, Colombia between January 2015, and November 2021. Clinical characteristics, endoscopic retrograde cholangiopancreatography (ERCP) findings, and outcomes are presented. Additionally, the success rates of Endoscopic Sphincterotomy Plus Large Balloon Dilation (ESLBD), Mechanical Lithotripsy (ML), temporary stenting (TS), cholangioscopy-guided laser lithotripsy (CGLL), and surgery are described. A total of 146 patients were included (median age 69 years, IQR 58.5-78.5, 33.8% men). The median stone diameter was 15 mm (IQR 10 - 18 mm). One stone was presented in 39.9%, two stones in 18.2%, and ≥3 stones in the remaining stone. A 67.6% disproportion rate was observed between the stone and distal common bile duct. Successful stone extraction was achieved in 56.2% in the first procedure, 22.6% in the second, 17.1% in the third, 3.4% in the fourth, and 0.7% in the fifth procedures. The successful extraction rates were 56.8% for ESLBD, 75% for ML, 23.4% for TS, 57.7% for CGLL, and 100% for surgery. Endoscopic management of difficult stones is usually successful, although it usually requires 2 or more ERCPs procedures. The surgical requirements were low. ESLBD is an effective technique unlike TS. Few patients required advanced techniques such as ML or CGLL. Endoscopic procedures are associated with a low rate of complications.

[Management of acute cholecystitis]. / Prise en charge de la cholécystite aiguë.

Acute cholecystitis is an inflammation of the gallbladder most often related to gallstones. The diagnostic and severity criteria are well described by the Tokyo criteria. Early laparoscopic cholecystectomy remains the treatment of choice. It can also be performed in elderly patients and in pregnant women during any trimester. For patients not eligible for surgery, percutaneous or echo-endoscopic gallbladder drainage (EUS-GBD) are effective treatment alternatives. The management of acute cholecystitis must therefore be adapted to each patient by carefully evaluating the risks and benefits associated with surgery.

La cholécystite aiguë est une inflammation de la vésicule biliaire le plus souvent liée à des calculs biliaires. Les critères diagnostiques et de sévérité sont bien décrits par les critères de Tokyo. La cholécystectomie laparoscopique précoce reste le traitement de choix. Elle peut être également réalisée chez les patients âgés et chez les femmes enceintes pendant n'importe quel trimestre. Pour les patients non éligibles à la chirurgie, les drainages de la vésicule biliaire par voie percutanée ou échoendoscopique (EUS-GBD) sont des alternatives thérapeutiques efficaces. La prise en charge de la cholécystite aiguë doit donc être adaptée à chaque patient en évaluant de façon attentive les risques et bénéfices associés à la chirurgie.

Acupoint Catgut Embedding as Adjunctive Therapy for Patients With Gallstones.

AIMS OF THIS STUDY: A randomized clinical trial was undertaken to investigate the efficacy of acupoint catgut embedding (ACE) as adjunctive therapy to tauroursodeoxycholic acid (TUDCA) therapy on gallbladder emptying and clinical symptoms in patients with gallstone disease. MATERIALS AND METHODS: Between August 2018 and January 2019, 70 patients with gallstones in our hospital were enrolled in this prospective clinical trial. All the patients were randomly divided into the ACE group (ACE+TUDCA treatment for 8 wk) and the Sham group (Sham ACE+TUDCA treatment for 8 wk). In the ACE group, all the patients were nightly given ACE every 2 weeks, and in 2 groups, every patient took TUDCA 500 mg at bedtime. The parameters about gallbladder emptying were detected by ultrasound before and after the treatment, and the clinical symptom scores were recorded at the same time points. RESULTS: A total of 63 patients with gallstone disease were included in our study, with 33 patients in the ACE group and 30 patients in the Sham group. In the ACE group, the empty volume (EV) and gallbladder ejection fraction (GBEF) were improved after treatment (P<0.05). Almost every symptom score (except symptom 7, P=0.15) and total score were decreased (P<0.05). In the Sham group, the symptom 1, 2, 4, 5 scores, and total score were significantly decreased (P<0.05). Moreover, the residual volume in the ACE group was significantly lower than in the Sham group (P=0.008). The EV and GBEF in the ACE group were higher than that in the Sham group (P<0.05). The score of symptom 6 in the ACE group was lower than that in the Sham group (P=0.008). CONCLUSION: ACE therapy could more effectively improve the gallbladder emptying with a shorter treatment course. Therefore, ACE+TUDCA therapy might be a time-saving treatment for gallstones.

A Preliminary Study on the Efficacy of Single-Operator Cholangioscopy with a New Basket for Residual Stone Retrieval After Mechanical Lithotripsy.

BACKGROUND AND AIM: The detection of residual or fragmented common bile duct (CBD) stones after lithotripsy can be improved by the high-resolution imaging quality of digital, single-operator cholangioscopy (SOC). However, therapeutic interventions for the removal of residual CBD stones are limited by the lack of appropriate tools. We retrospectively evaluated the role of SOC and the newly developed Dormia basket for the evaluation and removal of stones remaining after lithotripsy. METHODS: Thirty-four patients who had undergone lithotripsy for retained CBD stones with no evidence of filling defects in occluded balloon cholangiography from March 2017 to October 2018 were included in the study. After balloon cholangiography, the bile duct was evaluated by SOC for complete evacuation of the stones. The detected residual CBD stones were directly retrieved by inserting the newly developed Dormia basket into the working channel of the SOC. The incidence of residual stones detected by SOC and the success rate of residual stone retrieval by SOC were investigated. RESULTS: Digital SOC was successfully performed in all patients. Of these, 11 patients (32.4%) had residual CBD stones. The residual stones were successfully removed in 10 patients (90.9%) by SOC using the Dormia basket, except in one case of residual stones left in the hepatic duct. There were no adverse events associated with the SOC procedures or direct stone removal. CONCLUSIONS: Digital SOC combined with the newly developed Dormia basket was useful for the detection and extraction of residual CBD stones under direct visualization after lithotripsy.

Management of Difficult Choledocholithiasis.

Over 30% of all endoscopic retrograde cholangiography procedures in the US are associated with biliary stone extraction, and over 10-15% of these cases are noted to be complex or difficult. The aim of this review is to define the characteristics of difficult common bile duct stones and provide an algorithmic therapeutic approach to these difficult cases. We describe additional special clinical circumstances in which difficult biliary stones are identified and provide additional management strategies to aid endoscopic stone extraction efforts.

Percutaneous biliary stone clearance: is there still a need? A 10-year single-centre experience.

AIM: To evaluate the safety and efficacy of percutaneous biliary stone clearance in a single hepatopancreaticobiliary (HPB) centre. MATERIALS AND METHODS: All patients who underwent percutaneous biliary stone clearance between 2010 and 2020 at a HPB centre were identified from the radiology information system. Their demographic data, presentation, previous surgery, number/size of biliary calculi, success and complications were collected from patient records. Unpaired student's t-test was used to compare numerical variables and the Chi-square test was used to compare categorical data. RESULTS: Sixty-eight patients aged between 58.5-91.1 years underwent the procedure, and 42.6% (29/68) had the procedure due to surgically altered anatomy precluding endoscopic retrograde cholangiopancreatography (ERCP). The most common presentation was cholangitis (62%). The success rate of percutaneous stone clearance was 92.7%. The average number of calculi was two (range 1-12). Of the patients included, 4.4% developed pancreatitis, 4.4% developed cholangitis, and 1.5% had hepatic artery branch pseudoaneurysm successfully treated with transarterial embolisation. There was no significant difference in success or complication rates between the different access sites (right lobe, left lobe, roux-loop, T-tube, p=0.7767). CONCLUSION: Percutaneous biliary stone clearance is safe and effective and will continue to play an important role where ERCP fails or is impossible due surgically altered anatomy.

Fluoroscopy-guided percutaneous lithotripsy using FREDDY laser for giant gallstones: Preliminary experience.

OBJECTIVES: Percutaneous treatment of symptomatic cholelithiasis with large gallstones remains a challenge. We aimed to evaluate the efficacy and safety of a new method for the removal of giant gallstones with percutaneous lithotripsy using a frequency-doubled double-pulse neodymium: YAG (FREDDY) laser. MATERIALS AND METHODS: This study included 16 patients (7 males, 9 females; mean age, 63.4 ± 14.9 years) with giant gallstones who experienced the recurrence of cholecystitis and were not eligible for operation. The percutaneous transcystic approach was established using an 8-French sheath. A 6-French steerable sheath were inserted through the sheath. FREDDY laser lithotripsy was performed to break the stones into fragments. The stone fragments were extracted through the 6-French sheath or pushed into the duodenum using a balloon catheter. Cholecystography was performed before removing the catheter. Follow-up ultrasound or computed tomography examination were performed. RESULTS: Gallstone clearance was accomplished in 16 (100%) patients at the initial assessment. Eleven patients underwent one session, and five patients underwent two sessions. Residual stones were found in 3 (18.8%) patients during the follow-up period. Peritonitis was found in two (12.5%) patients and hemocholecyst was detected in one (6.3%) patient. No procedure-related deaths occurred. CONCLUSION: Percutaneous lithotripsy using a FREDDY laser may be an effective and safe alternative choice for treating giant gallstones, especially for patients who are not eligible for cholecystectomy.

[Diagnosis and treatment standardizations on percutaneous transhepatic papillary balloon dilation for common bile duct stones].

Common bile duct (CBD) stone is a prevalent disease. As a novel treatment for CBD stone in China, percutaneous transhepatic papillary balloon dilation (PTPBD) has shown some advantages compared with other modalities. However, many components of the procedure remains unclear, including indications, contraindications, patient preparation, bile duct puncture, papillary dilation, imaging interpretation, and complication management.In order to standardize the clinic practice of PTPBD, Chinese College of Interventionalists organized a committee, including interventional radiologists, digestive physicians and general surgeons, and commissioned this criterion.

Hypertriglyceridemia-Induced Pancreatitis and a Lipemic Blood Sample: A Case Report and Brief Clinical Review.

Hypertriglyceridemia is the third most common cause of acute pancreatitis after gallstones and long-term alcohol use. There are specific therapeutic options unique to hyperglyceridemia-induced pancreatitis, such as continuous insulin therapy and plasmapheresis, emphasizing the importance of identifying hypertriglyceridemia as the cause. Triglyceride levels > 1000 mg/dL may result in a visibly lipemic blood sample. Lipemic samples may interfere with laboratory equipment, resulting in erroneous levels or the inability to measure several serum blood tests. Consider hypertriglyceridemia as a cause for acute pancreatitis in the setting of a lipemic blood sample or when gallstones have been excluded.

Urgent endoscopic retrograde cholangiopancreatography with sphincterotomy versus conservative treatment in predicted severe acute gallstone pancreatitis (APEC): a multicentre randomised controlled trial.

BACKGROUND: It remains unclear whether urgent endoscopic retrograde cholangiopancreatography (ERCP) with biliary sphincterotomy improves the outcome of patients with gallstone pancreatitis without concomitant cholangitis. We did a randomised trial to compare urgent ERCP with sphincterotomy versus conservative treatment in patients with predicted severe acute gallstone pancreatitis. METHODS: In this multicentre, parallel-group, assessor-masked, randomised controlled superiority trial, patients with predicted severe (Acute Physiology and Chronic Health Evaluation II score ≥8, Imrie score ≥3, or C-reactive protein concentration >150 mg/L) gallstone pancreatitis without cholangitis were assessed for eligibility in 26 hospitals in the Netherlands. Patients were randomly assigned (1:1) by a web-based randomisation module with randomly varying block sizes to urgent ERCP with sphincterotomy (within 24 h after hospital presentation) or conservative treatment. The primary endpoint was a composite of mortality or major complications (new-onset persistent organ failure, cholangitis, bacteraemia, pneumonia, pancreatic necrosis, or pancreatic insufficiency) within 6 months of randomisation. Analysis was by intention to treat. This trial is registered with the ISRCTN registry, ISRCTN97372133. FINDINGS: Between Feb 28, 2013, and March 1, 2017, 232 patients were randomly assigned to urgent ERCP with sphincterotomy (n=118) or conservative treatment (n=114). One patient from each group was excluded from the final analysis because of cholangitis (urgent ERCP group) and chronic pancreatitis (conservative treatment group) at admission. The primary endpoint occurred in 45 (38%) of 117 patients in the urgent ERCP group and in 50 (44%) of 113 patients in the conservative treatment group (risk ratio [RR] 0·87, 95% CI 0·64-1·18; p=0·37). No relevant differences in the individual components of the primary endpoint were recorded between groups, apart from the occurrence of cholangitis (two [2%] of 117 in the urgent ERCP group vs 11 [10%] of 113 in the conservative treatment group; RR 0·18, 95% CI 0·04-0·78; p=0·010). Adverse events were reported in 87 (74%) of 118 patients in the urgent ERCP group versus 91 (80%) of 114 patients in the conservative treatment group. INTERPRETATION: In patients with predicted severe gallstone pancreatitis but without cholangitis, urgent ERCP with sphincterotomy did not reduce the composite endpoint of major complications or mortality, compared with conservative treatment. Our findings support a conservative strategy in patients with predicted severe acute gallstone pancreatitis with an ERCP indicated only in patients with cholangitis or persistent cholestasis. FUNDING: The Netherlands Organization for Health Research and Development, Fonds NutsOhra, and the Dutch Patient Organization for Pancreatic Diseases.

Efficacy and safety of peroral cholangioscopy with intraductal lithotripsy for difficult biliary stones: a systematic review and meta-analysis.

BACKGROUND : Peroral cholangioscopy with intraductal lithotripsy facilitates optically guided stone fragmentation of difficult biliary stones refractory to conventional endoscopic therapy. The aim of this study was to evaluate the efficacy and safety of peroral cholangioscopy with intraductal lithotripsy for difficult biliary stones. METHODS : Searches of PubMed, EMBASE, Web of Science, and Cochrane databases were performed in accordance with PRISMA and MOOSE guidelines. Measured outcomes included overall fragmentation success, single-session fragmentation and duct clearance, and rate of adverse events. Sensitivity and subgroup analyses were performed based upon cholangioscopy technique and type of lithotripsy (laser versus electrohydraulic). Heterogeneity was assessed with I 2 statistics. Publication bias was ascertained by funnel plot and Egger regression testing. RESULTS : 35 studies were included with 1762 participants (43.4 % men; mean age 61.5 [standard deviation (SD) 11.0]). Prior cholecystectomy had been performed in 37 % of patients, with a mean number of 1.6 (SD 0.5) ERCPs performed prior to lithotripsy. Mean stone size was 1.8 (SD 0.3) cm. Peroral cholangioscopy with intraductal lithotripsy achieved an overall stone fragmentation success of 91.2 % (95 %CI 88.1 % - 93.6 %; I 2 = 63.2 %) with an average of 1.3 [SD 0.6] lithotripsy sessions performed. Complete single-session fragmentation success was 76.9 % (95 %CI 71.6 % - 81.4 %; I 2 = 74.3 %). The adverse events rate was 8.9 % (95 %CI 6.5 % - 12.2 %; I 2 = 60.6 %). Mean procedure time for peroral cholangioscopy was 67.1 (SD 21.4) minutes. There was no difference in overall fragmentation rate or adverse events; however, laser lithotripsy was associated with a higher single-session fragmentation rate and shorter procedure time compared with electrohydraulic lithotripsy. CONCLUSIONS : Peroral cholangioscopy with intraductal lithotripsy appears to be a relatively safe and effective modality for difficult biliary stones.

Patients over 65 years with Acute Complicated Calculous Biliary Disease are Treated Differently-Results and Insights from the ESTES Snapshot Audit.

BACKGROUND: Accrued comorbidities are perceived to increase operative risk. Surgeons may offer operative treatments less often to their older patients with acute complicated calculous biliary disease (ACCBD). We set out to capture ACCBD incidence in older patients across Europe and the currently used treatment algorithms. METHODS: The European Society of Trauma and Emergency Surgery (ESTES) undertook a snapshot audit of patients undergoing emergency hospital admission for ACCBD between October 1 and 31 2018, comparing patients under and ≥ 65 years. Mortality, postoperative complications, time to operative intervention, post-acute disposition, and length of hospital stay (LOS) were compared between groups. Within the ≥ 65 cohort, comorbidity burden, mortality, LOS, and disposition outcomes were further compared between patients undergoing operative and non-operative management. RESULTS: The median age of the 338 admitted patients was 67 years; 185 patients (54.7%) of these were the age of 65 or over. Significantly fewer patients ≥ 65 underwent surgical treatment (37.8% vs. 64.7%, p < 0.001). Surgical complications were more frequent in the ≥ 65 cohort than younger patients, and the mean postoperative LOS was significantly longer. Postoperative mortality was seen in 2.2% of patients ≥ 65 (vs. 0.7%, p = 0.253). However, operated elderly patients did not differ from non-operated in terms of comorbidity burden, mortality, LOS, or post-discharge rehabilitation need. CONCLUSIONS: Few elderly patients receive surgical treatment for ACCBD. Expectedly, postoperative morbidity, LOS, and the requirement for post-discharge rehabilitation are higher in the elderly than younger patients but do not differ from elderly patients managed non-operatively. With multidisciplinary perioperative optimization, elderly patients may be safely offered optimal treatment. TRIAL REGISTRATION: ClinicalTrials.gov (Trial # NCT03610308).

Complications of common bile duct stones: A risk factors analysis.

BACKGROUND: The latest guidelines recommended that common bile duct stones (CBDSs) should be removed, preferably endoscopically, regardless of the presence of symptoms or complications. However, the removal of CBDSs may not be feasible in very old patients or those with co-morbidities. In these cases, it is important to understand the risk factors for the development of CBDSs-related complications to decide whether or not to treat high-risk patients. Herein, we aimed to identify the risk factors for the development of complications after the diagnosis of CBDSs. METHODS: The medical records of patients with CBDSs between October 2005 and September 2019 were retrospectively analyzed. All patients with radiologically-diagnosed CBDSs, including those who received treatment and those who did not, were analyzed. RESULTS: A total of 634 patients were included and 95 (15.0%) patients had CBDS-related complications during the mean follow-up period of 32.6 months. Forty-four (6.9%) high-risk patients remained asymptomatic and did not receive treatment during the follow-up period. In multivariate analyses, size of CBDSs ≥ 5 mm and no treatment within 30 days were independent risk factors for the development of complications. The spontaneous passage of CBDSs was proved radiologically in 9 out of 81 (11.1%) patients within 30 days. CONCLUSIONS: It is recommended treating CBDSs within 30 days from the diagnosis, even in high-risk patients, especially if the size is larger than 5 mm.

[Difficult or Complex Bile duct stones in ERCP: Large Balloon Dilation and other stone management methods. Accumulated experience in a referral Endoscopic Center 2009- 2018.] / Cálculos complejos o difíciles en la endoscopia de vía biliar (CPRE): dilatación con balones de gran diámetro y otros métodos de manejo. Experiencia acumulada en un centro endoscópico de referencia 2009-2018.

INTRODUCTION: Bile duct stones constitutes 20% of symptomatic gallbladder disease and difficult stones are one third of this. Endoscopic papillary large balloon dilation (EPLBD) with or without prior endoscopic sphincterotomy (EST) produces excellent outcomes for the treatment of complex or difficult common bile duct (CBD) stones, alone or combined with previous therapeutic options as mechanical lithotripsy (ML) and temporary or definitive stenting. OBJECTIVES: Show success rate, complications and adverse events. Show that higher success rates are obtained combining ERCP techniques with no increase in complications. MATERIALS AND METHODS: We evaluated the safety and therapeutic outcomes of EPLBD with vs. without EST and other combinations for the removal of difficult bile duct stones. We described our procedures for a decade and compare them with the previous decade without balloon dilation. Of 865 patients and procedures, 223 (25.78%) had difficult stones. Treatments where EPLBD with EST (n=183), EPLBD alone group (n=40). Additional modalities where required in 15.25% (n=34). These two groups were compared with respect to overall procedure-related adverse events, overall stone removal success rate, number of sessions required for complete stone removal, need for mechanical lithotripsy, temporal or definite stenting and total procedure time. Results Safety removal of stones was achieved in one session on 84.75% of cases with EPLBD. The incidence of adverse events was not significantly different between the groups (EPLBD alone vs. EPLBD with EST: overall adverse events 12.5% vs. 10.38% (including pain); pancreatitis 2.7% vs. 2.5%, p=0.62). Overall success similar, initial success similar, and the need for additional techniques were also similar between groups. Median total procedure time tended to be greater in the EPLBD alone group (20.5 minutes) than in the EPLBD with EST group. Conclusion DPBGD in ERCP allows bile duct stone extraction rates close to 99.65% (90% in previous decade) according to other reports of literature. Adverse events of EPLBD alone or with EST are similar between them and with classic ERCP without statistical difference and similar to other world series.

Restrictive strategy versus usual care for cholecystectomy in patients with gallstones and abdominal pain (SECURE): a multicentre, randomised, parallel-arm, non-inferiority trial.

BACKGROUND: International guidelines advise laparoscopic cholecystectomy to treat symptomatic, uncomplicated gallstones. Usual care regarding cholecystectomy is associated with practice variation and persistent post-cholecystectomy pain in 10-41% of patients. We aimed to compare the non-inferiority of a restrictive strategy with stepwise selection with usual care to assess (in)efficient use of cholecystectomy. METHODS: We did a multicentre, randomised, parallel-arm, non-inferiority study in 24 academic and non-academic hospitals in the Netherlands. We enrolled patients aged 18-95 years with abdominal pain and ultrasound-proven gallstones or sludge. Patients were randomly assigned (1:1) to either usual care in which selection for cholecystectomy was left to the discretion of the surgeon, or a restrictive strategy with stepwise selection for cholecystectomy. For the restrictive strategy, cholecystectomy was advised for patients who fulfilled all five pre-specified criteria of the triage instrument: 1) severe pain attacks, 2) pain lasting 15-30 min or longer, 3) pain located in epigastrium or right upper quadrant, 4) pain radiating to the back, and 5) a positive pain response to simple analgesics. Randomisation was done with an online program, implemented into a web-based application using blocks of variable sizes, and stratified for centre (academic versus non-academic and a high vs low number of patients), sex, and body-mass index. Physicians and patients were masked for study-arm allocation until after completion of the triage instrument. The primary, non-inferiority, patient-reported endpoint was the proportion of patients who were pain-free at 12 months' follow-up, analysed by intention to treat and per protocol. A 5% non-inferiority margin was chosen, based on the estimated clinically relevant difference. Safety analyses were also done in the intention-to treat population. This trial is registered at the Netherlands National Trial Register, number NTR4022. FINDINGS: Between Feb 5, 2014, and April 25, 2017, we included 1067 patients for analysis: 537 assigned to usual care and 530 to the restrictive strategy. At 12 months' follow-up 298 patients (56%; 95% CI, 52·0-60·4) were pain-free in the restrictive strategy group, compared with 321 patients (60%, 55·6-63·8) in usual care. Non-inferiority was not shown (difference 3·6%; one-sided 95% lower CI -8·6%; pnon-inferiority=0·316). According to a secondary endpoint analysis, the restrictive strategy resulted in significantly fewer cholecystectomies than usual care (358 [68%] of 529 vs 404 [75%] of 536; p=0·01). There were no between-group differences in trial-related gallstone complications (40 patients [8%] of 529 in usual care vs 38 [7%] of 536 in restrictive strategy; p=0·16) and surgical complications (74 [21%] of 358 vs 88 [22%] of 404, p=0·77), or in non-trial-related serious adverse events (27 [5%] of 529 vs 29 [5%] of 526). INTERPRETATION: Suboptimal pain reduction in patients with gallstones and abdominal pain was noted with both usual care and following a restrictive strategy for selection for cholecystectomy. However, the restrictive strategy was associated with fewer cholecystectomies. The findings should encourage physicians involved in the care of patients with gallstones to rethink cholecystectomy, and to be more careful in advising a surgical approach in patients with gallstones and abdominal symptoms. FUNDING: The Netherlands Organization for Health Research and Development, and CZ healthcare insurance.

Normalization of Serum Lipase Levels Versus Resolution of Abdominal Pain: A Comparison of Preoperative Management in Children With Biliary Pancreatitis.

BACKGROUND: Controversy exists over the timing of cholecystectomy for biliary pancreatitis in children. Some surgeons await normalization of serum lipase levels while others are guided by resolution of abdominal pain; however, there are minimal data to support either practice. We hypothesized that resolution of abdominal pain is equivalent in outcome to awaiting normalization of lipase levels in patients undergoing cholecystectomy for biliary pancreatitis. METHODS: After institutional review board (IRB) approval, the medical record was retrospectively queried for all cases of cholecystectomy for biliary pancreatitis at our institution from 2007 to 2017. Patients undergoing chemotherapy, admitted for another cause, or who had severe underlying comorbidities like ventilator dependence were excluded. Patients were stratified into two cohorts: those managed preoperatively by normalization of serum lipase levels versus resolution of abdominal pain. Demographics, serum lipase levels, postoperative complications, cost of stay, readmissions, and return to the emergency department were collected and analyzed using multivariate regression. RESULTS: Seventy-four patients met inclusion: 29 patients had lipase levels trended until normalization compared with 45 patients who had resolution of abdominal pain prior to cholecystectomy. Among the two cohorts there was no statistical difference in age, gender, race, ethnicity, or type of preoperative imaging used. Trended patients were found to have more serum lipase levels tested (8.5 ± 6.2 versus 3.4 ± 2.5, P < 0.0001). The trended lipase cohort was significantly more likely to require preoperative total parenteral nutrition (48% versus 11%, P = 0.007) and consequently a longer time before resuming a diet (10 ± 7.3 versus 4.6 ± 2.4 d, P < 0.0001). When comparing the two groups, we found no significant difference in the duration of surgery, postoperative complications, or readmissions. Lipase trended patients had a significantly longer length of stay compared with nontrended patients (11.5 ± 8.1 versus 4.2 ± 2.3 d, P < 0.0001) and had a higher total cost of stay ($38,094 ± 25,910 versus $20,205 ± 5918, P = 0.0007). CONCLUSIONS: Our data suggest that in children with biliary pancreatitis, proceeding with cholecystectomy after resolution of abdominal pain is equivalent in outcomes to trending serum lipase levels but is more cost-effective with a decreased length of stay and decreased need for preoperative total parenteral nutrition.

Cystic Duct Embolization with Chemical Gallbladder Ablation for the Treatment of Acute Calculous Cholecystitis in High-Risk Patients: A Prospective Single-Center Study.

PURPOSE: To demonstrate the feasibility of cystic duct embolization and chemical gallbladder ablation as an alternative to cholecystectomy in high-risk patients with calculous cholecystitis who were not candidates for surgery. MATERIALS AND METHODS: This prospective study included 10 patients with acute cholecystitis (7 males and 3 females) aged 70-91 years (average age, 81.6 years) between 2013 and 2019. A cholecystostomy catheter was inserted during the acute phase, followed by cystic duct coil embolization performed via the existing drainage tube tract. Once asymptomatic, 3% aethoxysklerol was injected into the gallbladder, and the drain was removed upon sonographic confirmation that the gallbladder remained contracted. Each phase of the procedure was performed with an interval of 2-3 weeks. Clinical, cholangiographic, and sonographic data were collected before and after drain removal at 1-month follow-up. RESULTS: Cystic duct embolization was technically successful in all patients, with no immediate post-procedure complications. Gallbladder ablation performed in 10 patients was technically successful in all of them (median follow-up, 11 months). One patient required repeat ablation at 14 months, and the prolonged biliary excretions of 1 other patient ceased only at 8 months. CONCLUSIONS: Cystic duct embolization with gallbladder ablation is a feasible procedure for patients in whom cholecystectomy is contraindicated.