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INTRODUCTION: Opioids used to manage severe pain in acute pancreatitis (AP) might exacerbate the disease through effects on gastrointestinal and immune functions. Methylnaltrexone, a peripherally acting µ-opioid receptor antagonist, may counteract these effects without changing analgesia. METHODS: This double-blind, randomized, placebo-controlled trial included adult patients with AP and systemic inflammatory response syndrome at 4 Danish centers. Patients were randomized to receive 5 days of continuous intravenous methylnaltrexone (0.15 mg/kg/d) or placebo added to the standard of care. The primary end point was the Pancreatitis Activity Scoring System score after 48 hours of treatment. Main secondary outcomes included pain scores, opioid use, disease severity, and mortality. RESULTS: In total, 105 patients (54% men) were randomized to methylnaltrexone (n = 51) or placebo (n = 54). After 48 hours, the Pancreatitis Activity Scoring System score was 134.3 points in the methylnaltrexone group and 130.5 points in the placebo group (difference 3.8, 95% confidence interval [CI] -40.1 to 47.6; P = 0.87). At 48 hours, we found no differences between the groups in pain severity (0.0, 95% CI -0.8 to 0.9; P = 0.94), pain interference (-0.3, 95% CI -1.4 to 0.8; P = 0.55), and morphine equivalent doses (6.5 mg, 95% CI -2.1 to 15.2; P = 0.14). Methylnaltrexone also did not affect the risk of severe disease (8%, 95% CI -11 to 28; P = 0.38) and mortality (6%, 95% CI -1 to 12; P = 0.11). The medication was well tolerated. DISCUSSION: Methylnaltrexone treatment did not achieve superiority over placebo for reducing the severity of AP.

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INTRODUCTION: Inter-hospital variation in the management of small bowel obstruction (SBO) has been described in other countries, but the extent to which similar variations exist in Denmark remains unknown. This study aimed to compare the management of SBO between hospitals in Denmark and identify potential areas for improvement METHODS. This was a multicentre prospective study performed at six emergency hospitals. Patients aged ≥ 18 years with a diagnosis of SBO were eligible for inclusion. The primary study endpoints were the proportion of patients undergoing operative versus non-operative management, laparoscopic surgery versus open surgery and the success rate of non-operative management. RESULTS: A total of 316 patients were included. No differences were noted in diagnostic pathways or operative versus non-operative management. However, variations were noted in compliance with peri-operative care bundles, ranging from 63.2% to 95.8%. The surgical approach also varied, with the use of laparoscopic surgery ranging from 20.7% to 71.0% (p less-than 0.001). Variations were also noted in duration of surgery (63-124 minutes, p less-than 0.001), time to re-introduction of normal diet and length of hospital stay (3-8.5 days, p less-than 0.001). No differences were observed in 30-day or 90-day mortality rates. CONCLUSION: The management of SBO in Denmark is relatively standardised. Future efforts should focus on improving adherence to multidisciplinary peri-operative protocols, optimising patient selection for laparoscopic surgery and standardising nutritional therapy. FUNDING: None. TRIAL REGISTRATION: NCT04750811.

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BACKGROUND: Moderate to severe acute pancreatitis (AP) is associated with a high rate of complications and increased mortality, yet no targeted pharmacologic treatment currently exists. As pain is a dominant symptom in AP, patients are exposed to excess levels of both endo- and exogenous opioids, which may have harmful effects on the course of AP. This trial investigates the effects of the peripherally acting µ-opioid receptor antagonist (PAMORA) methylnaltrexone on disease severity and clinical outcomes in patients with moderate to severe AP. METHODS: PAMORA-AP is a multicentre, investigator-initiated, double-blind, randomised, placebo-controlled, interventional trial, which will be conducted at four referral centres for acute pancreatitis in Denmark. Ninety patients with early-onset AP (pain onset within 48 h) as well as predicted moderate to severe disease (two or more systemic inflammatory response syndrome criteria upon admission) will be prospectively included. Subsequently, participants will be randomised (1:1) to intravenous treatment with either methylnaltrexone or matching placebo (Ringer's lactate) during 5 days of admission. The primary endpoint will be the group difference in disease severity as defined and measured by the Pancreatitis Activity Scoring System (PASS) score 48 h after randomisation. Secondary endpoints include daily PASS scores; disease severity according to the Atlanta classification; quantification of need for analgesics, nutritional support, intravenous fluid resuscitation and antibiotics; duration of hospital admissions, readmission rates and mortality. Pain intensity and gut function will be self-reported using validated questionnaires. Exploratory endpoints include circulating levels of pro-and anti-inflammatory markers, polyethylene glycol recovery from the urine, circulating levels of blood markers of intestinal permeability, the prevalence of pancreatic complications on computed tomography (CT) scans, and colon transit time assessed using a CT-based radiopaque marker method. DISCUSSION: This trial aims to evaluate the PAMORA methylnaltrexone as a novel targeted pharmacotherapy in patients with moderate to severe AP with the potential benefit of improved patient outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04743570 . Registered on 28 January 2021. EudraCT 2020-002313-18.

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Objectives: Two-stage treatment of common bile duct stones by Endoscopic Retrograde Cholangio-Pancreatography and subsequent laparoscopic cholecystectomy is well established. In many cases multiple procedures are needed before clearance of the common bile duct is obtained. This study aimed to describe the clinical course from common bile duct stone diagnosis to successful clearance. Materials and Methods: A prospective observational study from 2011 to 2014 of consecutive patients diagnosed with common bile duct stones undergoing Endoscopic Retrograde Cholangio-Pancreatography at a public university hospital. Results: In this study 297 patients with common bile duct stones were identified. More than one Endoscopic Retrograde Cholangio-Pancreatography was performed in 174 (59%) patients and more than two in 51(17%) before clearance. A sphincterotomy was performed in 269 (91%) patients and 189 (64%) had a stent inserted. Bleeding occurred in 17 (6%) requiring injection treatment and post procedure complications occurred in 38 (13%). Subsequent laparoscopic cholecystectomy was performed in 180 (61%) patients. Overall, the patients were hospitalized for 11 (8.5) days and the length of treatment from diagnose to stone clearance was 49 (84.5) days. Overweight, pancreatitis at admission, universal anesthesia, and expert level endoscopist inversely determined common bile duct clearance failure. Conclusions: Common bile duct clearance by Endoscopic Retrograde Cholangio-Pancreatography requires multiple procedures and complications are frequent leading to prolonged treatment and hospitalization suggesting a limited efficacy.

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INTRODUCTION: Laparoscopy is well established in the majority of elective procedures in abdominal surgery. In contrast, it is primarily used in minor surgery such as appendectomy or cholecystectomy in the emergent setting. This study aimed to analyze the safety and effectiveness of a laparoscopic approach in a large cohort of major abdominal emergencies. METHODS: A population-based cohort from the Region of Copenhagen, Denmark, including n = 1,139 patients undergoing major abdominal emergency surgery in 2012. RESULTS: A total of 313 patients were operated with an initial laparoscopic approach; 37% were laparoscopically completed and 63% of the operations were converted to a laparotomy. Most conversions (40%) were for performing a bowel resection, 35% were due to inadequate exposure, 2% were converted due to accidental bleeding and 7% due to iatrogenic injuries. The reoperation rate was 17% in the laparoscopically completed group versus 19% in the group converted to laparoscopy and 20% in the open group. Major complications occurred after 31.6% of the laparoscopically completed operations, after 46.4% of the converted operations and after 49.5% of the open operations. The median length of stay was eight days in the laparoscopic group, 12 days in the converted group and 11 days in the group of open operations. CONCLUSIONS: In a large, unselected group of major abdominal emergencies, we report a low rate of complications for operations conducted by an initial laparoscopic approach, and a high rate of conversion to open surgery, with 10% of the entire study population obtaining the benefits of a laparoscopic approach. FUNDING: none. TRIAL REGISTRATION: not relevant.

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Amyloidosis is a disease characterized by abnormal extracellular deposits of protein. The disease may affect the stomach, however, symptoms are rare in this case. Furthermore, the rare symptoms are diffuse and unspecific and the diagnosis relies on biopsy. We report the case of a 79-year-old female presenting with melaena and no history of amyloidosis. Gastroscopy raised suspicion of a malignant process in the stomach, but biopsy revealed gastric amyloidosis. The treatment of gastric involvement is primarily symptomatic, and causal treatment is reserved for the few.

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BACKGROUND: The number of Danish inhabitants older than 65 years is increasing, and cholecystectomy is one of the most common surgical procedures performed for this age group. This study aimed to analyze the role of age as an independent predictor of outcome for elderly cholecystectomy patients. METHODS: Data from the Danish Cholecystectomy Database (2006-2010) were used. The outcomes of interest were conversion rate for laparoscopic cholecystectomy, outpatient rate, postoperative hospital length of stay, readmission rate, and frequency of additional procedures and death within 30 days postoperatively. RESULTS: In this study, 697 patients 80 years of age or older and 4,915 patients ages 65-70 years were compared with 8,805 patients ages 50-64 years. Significantly more patients age 80 years or older underwent surgery for acute cholecystitis, and the conversion rate from laparoscopic to open surgery was significantly higher in the oldest group. The older patients had longer postoperative hospital stays, but nearly 30 % of the patients age 80 years or older were admitted for only 0-1 day and not readmitted, and nearly half of the patients were admitted for only 0-3 days without readmission. Also, the mortality rate and the number of patients who underwent additional procedures within 30 days were higher in the oldest group (6 vs 0.1 and 28 vs 15 %, respectively). A subanalysis of the patients age 80 years or older classified as American Society of Anesthesiology 1 and 2 without acute cholecystitis showed that 44 % left the hospital within 1 day and 63 % within 3 days without readmission and that the 30-day mortality rate was only 2 %. CONCLUSIONS: Age is an independent predictor for worse outcome after cholecystectomy. However, among otherwise healthy patients age 80 years or older who underwent surgery before acute inflammatory complications occurred, 63 % had a fast and uncomplicated course. Thus, it seems fair to recommend elective laparoscopic cholecystectomy when repeated gallstone symptoms have occurred also for the older patient, particularly before the patient experiences acute cholecystitis.

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