Laparoscopic cholecystectomy versus antibiotic therapy for acute cholecystitis in patients over 75 years: Randomized clinical trial and retrospective cohort study.

BACKGROUND AND OBJECTIVE: The prevalence of acute cholecystitis among elderly patients is increasing. The aim of this study was to compare laparoscopic cholecystectomy (LC) to antibiotics in elderly patients with acute cholecystitis. METHODS: A randomized multicenter clinical trial including patients over 75 years with acute calculous cholecystitis was conducted in four hospitals in Finland between January 2017 and December 2019. Patients were randomized to undergo LC or antibiotic therapy. Due to patient enrollment challenges, the trial was prematurely terminated in December 2019. To assess all eligible patients, we performed a retrospective cohort study including all patients over 75 years with acute cholecystitis during the study period. The primary outcome was morbidity. Predefined secondary outcomes included mortality, readmission rate, and length of hospital stay. RESULTS: Among 42 randomized patients (LC n = 24, antibiotics n = 18, mean age 82 years, 43% women), the complication rate was 17% (n = 4/24) after cholecystectomy and 33% (n = 6/18, 5/6 patients underwent cholecystectomy due to antibiotic treatment failure) after antibiotics (p = 0.209). In the retrospective cohort (n = 630, mean age 83 years, 49% women), 37% (236/630) of the patients were treated with cholecystectomy and 63% (394/630) with antibiotics. Readmissions were less common after surgical treatment compared with antibiotics in both randomized and retrospective cohort patients (8% vs 44%, p < 0.001% and 11 vs 32%, p < 0.001, respectively). There was no 30-day mortality within the randomized trial. In the retrospective patient cohort, overall mortality was 6% (35/630). CONCLUSIONS: LC may be superior to antibiotic therapy for acute cholecystitis in the selected group of elderly patients with acute cholecystitis.

One-year functional outcomes of patients aged 80 years or more undergoing colonic cancer surgery: prospective, multicentre observational study.

BACKGROUND: Older patients are at high risk of experiencing delayed functional recovery after surgical treatment. This study aimed to identify factors that predict changes in the level of support for activities of daily living and mobility 1 year after colonic cancer surgery. METHODS: This was a multicentre, observational study conforming to STROBE guidelines. The prospective data included pre-and postoperative mobility and need for support in daily activities, co-morbidities, onco-geriatric screening tool (G8), clinical frailty scale (CFS), operative data, and postoperative surgical outcomes. RESULTS: A total of 167 patients aged 80 years or more with colonic cancer were recruited. After surgery, 30 per cent and 22 per cent of all patients had increased need for support and decreased motility. Multivariableanalysis with all patients demonstrated that preoperative support in daily activities outside the home (OR 3.23, 95 per cent c.i. 1.06 to 9.80, P = 0.039) was associated with an increased support at follow-up. A history of cognitive impairment (3.15, 1.06 to 9.34, P = 0.038) haemoglobin less than 120 g/l (7.48, 1.97 to 28.4, P = 0.003) and discharge to other medical facilities (4.72, 1.39 to 16.0, P = 0.013) were independently associated with declined mobility. With functionally independent patients, haemoglobin less than 120 g/l (8.31, 1.76 to 39.2, P = 0.008) and discharge to other medical facilities (4.38, 1.20 to 16.0, P = 0.026) were associated with declined mobility. CONCLUSION: Increased need for support before surgery, cognitive impairment, preoperative anaemia, and discharge to other medical facilities predicts an increased need for support or declined mobility 1 year after colonic cancer surgery. Preoperative assessment and optimization should focus on anaemia correction, nutritional status, and mobility with detailed rehabilitation plan.

The Clinical Frailty Scale is a useful tool for predicting postoperative complications following elective colon cancer surgery at the age of 80 years and above: A prospective, multicentre observational study.

AIM: Identification of the risks of postoperative complications may be challenging in older patients with heterogeneous physical and cognitive status. The aim of this multicentre, observational study was to identify variables that affect the outcomes of colon cancer surgery and, especially, to find tools to quantify the risks related to surgery. METHOD: Patients aged ≥80 years with electively operated Stage I-III colon cancer were recruited. The prospectively collected data included comorbidities, results of the onco-geriatric screening tool (G8), Clinical Frailty Scale (CFS), Charlson Comorbidity Index (CCI) and Mini Nutritional Assessment-Short Form (MNA-SF), and operative and postoperative outcomes. RESULTS: A total of 161 patients (mean 84.5 years, range 80-97, 60% female) were included. History of cerebral stroke (64% vs. 37%, p = 0.02), albumin level 31-34 g/l compared with ≥35 g/l (57% vs. 32%, p = 0.007), CFS 3-4 and 5-9 compared with CFS 1-2 (49% and 47% vs. 16%, respectively) and American Society of Anesthesiologists score >3 (77% vs. 28%, P = 0.006) were related to a higher risk of complications. In multivariate logistic regression analysis CFS ≥3 (OR 6.06, 95% CI 1.88-19.5, p = 0.003) and albumin level 31-34 g/l (OR 3.88, 1.61-9.38, p = 0.003) were significantly associated with postoperative complications. Severe complications were more common in patients with chronic obstructive pulmonary disease (43% vs. 13%, p = 0.047), renal failure (25% vs. 12%, p = 0.021), albumin level 31-34 g/l (26% vs. 8%, p = 0.014) and CCI >6 (23% vs. 10%, p = 0.034). CONCLUSION: Surgery on physically and cognitively fit aged colon cancer patients with CFS 1-2 can lead to excellent operative outcomes similar to those of younger patients. The CFS could be a useful screening tool for predicting postoperative complications.

Perioperative EOX treatment in operable locally advanced gastroesophageal adenocarcinoma: Prediction of tumor response by FDG -PET and histopathology.

PURPOSE: The aim of this retrospective single-center analysis was to evaluate the feasibility of fluorine-18 fluorodeoxyglucose (FDG)-PET imaging in evaluating metabolic response of preoperative chemotherapy in the treatment of locally advanced operable gastroesophageal adenocarcinoma and to investigate the association between histopathologic and FDG-PET response and overall survival. METHODS: Patients with locally advanced adenocarcinoma of distal esophagus, gastroesophageal junction or stomach were assessed for the study during 2008-2012. After evaluation with endoscopy, computed tomography and FDG-PET, patients with clinical stage II or III disease were assigned for perioperative EOX (epirubicin-oxaliplatin-capecitabine) treatment targeted at three cycles both pre- and postoperatively, if possible. Metabolic response was evaluated by repeated FDG-PET during or right after the second chemotherapy cycle. Becker tumor regression grade (TRG) was used to evaluate histopathologic response. For statistical purposes, the clinically significant cut-off for tumor maximum standardized uptake value (SUVmax) change (SUVδ%) was set at -35%. RESULTS: 54 patients were included in the study. 53 PET images were obtained before chemotherapy, 11 (21%) of those were PET negative. A major metabolic response was detected in 19 patients and major histopathologic response in 14 patients. No statistically significant association was observed between SUVδ% and histopathological responses. Median overall survival (OS) time of the patients was 49.9 months. No association between OS and PET response was found in our study. The administration of all six cycles of perioperative EOX was associated with improved OS. CONCLUSIONS: Follow-up PET during or right after second preoperative chemotherapy cycle did not assist in identifying patients with favorable histopathological response or OS.

Antireflux Versus Conventional Plastic Stent in Malignant Biliary Obstruction: A Prospective Randomized Study.

OBJECTIVE: Endoscopic stents are used to relieve obstructive jaundice. The purpose of this prospective randomized study was to compare the patency of antireflux and conventional plastic biliary stent in relieving distal malignant biliary obstruction. MATERIALS AND METHODS: All jaundiced patients admitted to hospital with suspected unresectable malignant distal biliary stricture between October 2009 and September 2010 were evaluated for the study. Eligible patients were randomized either to antireflux or conventional plastic stent arms. The primary endpoint was stent patency and the follow-up was continued either until the stent was occluded or until 6 months after the stent placement. RESULTS: At an interim analysis, antireflux stents (ARSs; n = 6) had a significantly shorter median patency of 34 (8-49) days compared with the conventional stent (n = 7) patency of 167 (38-214) days (P = .0003). Based on these results, the study was terminated due to ethical concerns. CONCLUSION: According to these results, the use of this ARS is not recommended.

Angled- or straight-tipped hydrophilic guidewire in biliary cannulation: a prospective, randomized, controlled trial.

BACKGROUND: Deep biliary cannulation is the key for successful endoscopic retrograde cholangiopancreatography (ERCP) procedures. Guidewire-assisted cannulation is associated both with a higher success rate and a reduced risk of post-ERCP pancreatitis compared with standard catheter cannulation. However, to our knowledge there are no prospective, randomized studies comparing the use of different guidewires in biliary cannulation. The goal of this study was to compare the performance of an angled-tipped guidewire (AGW) with a straight-tipped guidewire (SGW) in achieving successful deep biliary cannulation. METHODS: Patients with intended biliary cannulation of an intact papilla were prospectively randomized to angled- or straight-tipped hydrophilic guidewire arms in a tertiary, referral, university hospital setting. Randomized cannulation method was applied either until successful cannulation of the bile duct or until 2 min had passed. Crossover was not included in the study protocol. The main outcome measurements were the cannulation success rate and duration of cannulation. RESULTS: Of the 239 consecutive patients, 155 patients were randomized: in the final analysis 70 patients were included in the AGW arm and 83 patients in the SGW arm. Cannulation time [median; seconds (s)] was shorter with the AGW compared with the SGW (20 vs. 63 s, p = 0.01). There was no difference in the cannulation success rate or the complication rate between the two study groups. CONCLUSIONS: AGW may facilitate biliary cannulation in ERCP.

Feasibility of the novel 3-step protocol for biliary cannulation--a prospective analysis.

Traditionally, a 2-step protocol has been used for deep biliary cannulation. The purpose of the present prospective study was to find out the feasibility and safety of the novel sequential 3-step protocol (traditional cannula with guidewire, double-guidewire, and needle-knife techniques) for deep biliary cannulation. All consecutive patients admitted for endoscopic retrograde cholangiopancreatography (ERCP) to a single, very experienced ERCP endoscopist during the year 2009 with intended biliary cannulation and with unhindered access to a native papilla (n=105) were included in the present study. The overall success rate for deep biliary cannulation was 99% (104/105). Cannulation with cannula and guidewire was attempted in all patients and proved successful in 80% (84/105) of the attempts, the double-guidewire technique was applied in 19% (20/105) and was successful in 65% (13/20) of the cases, and the needle-knife technique was applied in 7% (7/105) with success in all cases. The median cannulation time was 1 minute (range, 0 to 27 min). The rate of post-ERCP pancreatitis was 3% (3/105) and post-ERCP cholangitis 2% (2/105). We conclude that in experienced hands, the novel sequential 3-step protocol for biliary cannulation tested herein proved to be an effective cannulation protocol with the overall success rate of 99%. The complication rate of these ERCP procedures (5%) was within acceptable limits.

Female gender and post-ERCP pancreatitis: is the association caused by difficult cannulation?

OBJECTIVE: Female gender is a well-known risk factor for the development of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis, but the underlying mechanism for this increased risk has remained unknown. We hypothesize that cannulation difficulty might play a part in this association. The aim of the current study was to determine whether the female papilla is more difficult to cannulate than the male papilla. MATERIAL AND METHODS: Prospective data collection with emphasis on cannulation was conducted in 364 consecutive biliary ERCP procedures performed by very experienced ERCP endoscopists through native papilla in a tertiary referral university hospital. RESULTS: Although the cannulation times seemed to be longer and alternative cannulation techniques seemed to be needed more frequently for successful cannulation in female than male patients, no statistically significant differences (p = 0.061 and 0.054, respectively) in the cannulation process could be found between the genders. CONCLUSIONS: The study was not able to confirm that the cannulation of the female papilla is more troublesome than the cannulation of the male papilla.

Double-guidewire-assisted biliary cannulation: experiences from a single tertiary referral center.

BACKGROUND: Even in experienced hands, a common problem with endoscopic retrograde cholangiopancreatography (ERCP) is difficulty reaching a deep biliary cannulation. The most recent alternative method for difficult biliary cannulation is the double-guidewire technique. The current prospective study aimed to clarify the feasibility and safety of the double-guidewire-assisted biliary cannulation at the authors' institution. METHODS: All consecutive patients (n=284) admitted for biliary ERCP during 2009 who had unhindered access to a native papilla were included in the study. The application and success rates of the double-guidewire method for deep biliary cannulation and the complications of ERCP procedures using the double-guidewire technique were determined. The overall success rate for biliary cannulation in these cases also was determined, and the times from the first touch to the papilla to deep biliary cannulation and for the entire ERCP procedure were recorded. RESULTS: The double-guidewire-assisted cannulation technique was applied in 18% (50/284) of ERCPs with a success rate of 66% (33/50). In these 50 cases, the overall success rate for biliary cannulation was 98% (49/50). The median cannulation time was 8 min, and the median duration of the entire ERCP procedure was 20 min. The rate of post-ERCP pancreatitis was 2% (1/50). CONCLUSIONS: The double-guidewire technique is a feasible and safe method for difficult biliary cannulation with low rate of post-ERCP pancreatitis. However, it seems important to proceed to alternative cannulation techniques if the double-guidewire technique appears troublesome.