Endoscopic submucosal dissection for removal of large colorectal neoplasias in an outpatient setting: a single-center series of 660 procedures in Sweden.

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is a technique developed in Japan for the removal of large lesions in the GI tract. Because of the complexity of the technique, implementation in Western health care has been slow. An ESD procedure is usually followed by hospital admission. Our aim was to investigate if ESD of colorectal lesions can be performed in an outpatient setting. METHODS: Six hundred sixty colorectal ESD procedures between 2014 and 2020 were evaluated retrospectively. All patients referred to the unit with an early colorectal neoplasm >20 mm without signs of deep invasion were considered eligible for an ESD procedure. RESULTS: Of 660 lesions, 323 (48.9%) were localized in the proximal colon, 102 (15.5%) in the distal colon, and 235 (35.6%) in the rectum. Median lesion size was 38 mm (interquartile range, 30-50) and median procedure duration 70 minutes (interquartile range, 45-115). En-bloc resection was achieved in 620 cases (93.9%). R0 resection was achieved in 492 en-bloc resections (79.4%), whereas the number of Rx and R1 resections was 124 (20.0%) and 4 (.6%), respectively. Low-grade dysplasia was found in 473 cases (71.7%), high-grade dysplasia in 144 (21.8%), and adenocarcinoma in 34 (5.1%). Six hundred twelve procedures (92.7%) were scheduled as outpatient, and 33 of these underwent unplanned admission. Forty-eight cases (7.3%) were planned as inpatient procedures. The rate of full wall perforation was 38 (5.8%), in which 35 (92.1%) were managed endoscopically and 3 patients (7.9%) required emergency surgery. Forty-six patients (7.0%) sought medical attention within 30 days because of bleeding (21 [3.2%]), abdominal tenderness (16 [2.4%]), and other reasons (9 [1.4%]). Twenty-four of these patients were admitted for observation for a median of 2 days (range, 1-7). Ten of these patients were treated with antibiotics, and 6 patients required blood transfusion. None required additional surgery. CONCLUSIONS: ESD of colorectal lesions can be safely performed in an outpatient setting in a well-selected patient.

Pattern of care for cancer of the oesophagus in a western population.

BACKGROUND: Most oesophageal outcome research focuses on surgical treatment, despite most patients not undergoing surgery as they are unfit or have metastatic disease. Few studies have evaluated the patterns of care for all patients presenting with oesophageal cancer. METHODS: All patients with oesophageal cancer, and high-grade dysplasia (HGD), presented at the South Australian state-wide upper gastrointestinal cancer multidisciplinary team from 2012 to 2015 were reviewed to determine the patterns of presentation and treatment. RESULTS: A total of 375 patients were included. Diagnosis was adenocarcinoma in 69.6%, squamous cell carcinoma in 24.8% and HGD in 5.6%. The majority of patients presented with stages II and III disease (56.8%). A total of 51.5% were treated with curative intent, with 28.8% undergoing surgery and/or neoadjuvant therapy. Treatment was palliative in 48.5%, with chemoradiotherapy utilized in 20.8%. Disease stage and age impacted treatment intent. All patients with HGD received curative treatment versus 89.7%/63.8%/1% of patients with stage I/II and III/IV disease, respectively. A total of 56.9% of patients <80 years received curative treatment versus 25% of those >80 years old. CONCLUSION: Whilst approximately half of patients underwent treatment with curative intent, only a minority underwent surgery. Future efforts to improve survival outcomes for oesophageal cancer should address patients who are unfit for surgery and those presenting with metastatic disease.

Preferences for Surveillance of Barrett's Oesophagus: a Discrete Choice Experiment.

PURPOSE: Endoscopic surveillance for Barrett's oesophagus is undertaken to detect dysplasia and early cancer, and to facilitate early intervention. Evidence supporting current practice is of low quality and often influenced by opinion. This study investigated the preferences of patients for surveillance of Barrett's oesophagus in an Australian cohort. METHODS: Four Barrett's oesophagus surveillance characteristics/attributes were evaluated within a discrete choice experiment based on literature and expert opinion: (1) surveillance method (endoscopy vs a blood test vs a novel breath test), (2) risk of missing a cancer over a 10-year period, (3) screening interval, and (4) out-of-pocket cost. The data from the discrete choice experiment was analysed within the framework of random utility theory using a mixed logit regression model. RESULTS: The study sample comprised patients (n = 71) undergoing endoscopic surveillance for Barrett's oesophagus of whom n = 65 completed the discrete choice experiment. The sample was predominantly male (77%) with average age of 65 years. All attributes except surveillance method significantly influenced respondents' preference for Barrett's oesophagus surveillance. Policy analyses suggested that compared to the reference case (i.e. endoscopy provided annually at no upfront cost and with a 4% risk of missing cancer), increasing test sensitivity to 0.5% risk of missing cancer would increase participation by up to 50%; surveillance every 5 years would lead to 26% reduction, while every 3 to 3.5 years would result in 7% increase in participation. Respondents were highly averse to paying A$500 for the test, resulting in 48% reduction in participation. None of the other surveillance methods was preferred to endoscopy, both resulting in 11% reduction in participation. CONCLUSION: Test sensitivity, test frequency and out-of-pocket cost were the key factors influencing surveillance uptake. Patients prefer a test with the highest sensitivity, offered frequently, that incurs no upfront costs.

Proposed standards for reporting outcomes of treating biliary injuries.

BACKGROUND: There is no standard nor widely accepted way of reporting outcomes of treatment of biliary injuries. This hinders comparison of results among approaches and among centers. This paper presents a proposal to standardize terminology and reporting of results of treating biliary injuries. METHODS: The proposal was developed by an international group of surgeons, biliary endoscopists and interventional radiologists. The method is based on the concept of "patency" and is similar to the approach used to create reporting standards for arteriovenous hemodialysis access. RESULTS: The group considered definitions and gradings under the following headings: Definition of Patency, Definition of Index Treatment Periods, Grading of Severity of Biliary Injury, Grading of Patency, Metrics, Comparison of Surgical to Non Surgical Treatments and Presentation of Case Series. CONCLUSIONS: A standard procedure for reporting outcomes of treating biliary injuries has been produced. It is applicable to presenting results of treatment by surgery, endoscopy, and interventional radiology.

The impact of prophylactic pancreatic stenting on post-ERCP pancreatitis: A nationwide, register-based study.

BACKGROUND AND OBJECTIVES: The role of prophylactic pancreatic stenting (PS) in preventing post-endoscopic retrograde cholangio-pancreatography (ERCP) pancreatitis (PEP) has yet to be determined. Most previous studies show beneficial effects in reducing PEP when prophylactic pancreatic stents are used, especially in high-risk ERCP procedures. The present study aimed to address the use of PS in a nationwide register-based study in which the primary outcome was the prophylactic effect of PS in reducing PEP. METHODS: All ERCP-procedures registered in the nationwide Swedish Registry for Gallstone Surgery and ERCP (GallRiks) between 2006 and 2014 were studied. The primary outcome was PEP but we also studied other peri- and postoperative complication rates. RESULTS: Data from 43,595 ERCP procedures were analyzed. In the subgroup of patients who received PS with a total diameter ≤ 5 Fr, the risk of PEP increased nearly four times compared to those who received PS with a total diameter of >5 Fr (OR 3.58; 95% CI 1.40-11.07). Furthermore, patients who received PS of >5 Fr and >5 cm had a significantly lower pancreatitis frequency compared to those with shorter stents of the same diameter (1.39% vs 15.79%; p = 0.0033). CONCLUSIONS: PS with a diameter of >5 Fr and a length of >5 cm seems to have a better protective effect against PEP, compared to shorter and thinner stents. However, in the present version of GallRiks it is not possible to differentiate the exact type of pancreatic stent (apart from material, length and diameter) that has been introduced, so our conclusion must be interpreted with caution.

The H.O.U.S.E. classification: a novel endoscopic retrograde cholangiopancreatography (ERCP) complexity grading scale.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) is a technically challenging endoscopic procedure, harboring a wide range of complexities within every single investigation. Classifications of the complexity of ERCP have been presented, but do not include modern endoscopic treatment modalities. In order to be able to target resources and compare the results of different endoscopic centers, a new complexity grading system for ERCP is warranted. This study launches a new complexity grading scale for ERCP-the H.O.U.S.E.-classification. METHODS: The medical record of every patient undergoing ERCP 2009-2011 at the Karolinska University Hospital was reviewed, regarding the complexity of the procedure, and categorized into one out of three-grades in the HOUSE classification system, and concomitantly graded according to the Cotton grading system. All ERCP-procedures were also registered in the Swedish registry for gallstone surgery and ERCP (GallRiks) and correlations between the grading systems and procedure related variables as well as outcomes were made. RESULTS: Between 2009 and 2011, 2185 ERCPs were performed at the Karolinska University Hospital, Huddinge. One thousand nine hundred fifty-four of those were index-ERCPs. Another 23 patients were excluded due to lack of postoperative complication registrations, leaving 1931 ERCP procedures to be analyzed. The procedure times were 40 ± 0.7, 65 ± 1.5 and 106 ± 3.2 min, respectively (HOUSE 1-3). The corresponding pancreatitis rates were 3.4, 7.0 and 6.8% and the postoperative complication rates 11.1, 15.7 and 12.8%, respectively. CONCLUSIONS: The HOUSE-classification is a novel grading scale for ERCP-complexity. The system can be implemented in clinical practice to allocate resources and allow the comparisons of results between different endoscopic centers. Further studies are warranted to further sharpen this instruments validitity and general clinical relevance.

Severity of Acute Cholecystitis and Risk of Iatrogenic Bile Duct Injury During Cholecystectomy, a Population-Based Case-Control Study.

BACKGROUND: Acute cholecystitis is a common complication to gallstone disease. The relation between the severity of acute cholecystitis and risk of bile duct injury during cholecystectomy has not yet been addressed and is the main focus of this study. METHODS: All cases with iatrogenic bile duct injury during cholecystectomy, within the Lake Mälaren region, Sweden, were identified through ICD procedure codes for biliary reconstruction within the Swedish Inpatient Register and matched to non-injured cholecystectomized controls. Information regarding perioperative variables was collected through medical record review. RESULTS: After review, 158 cases and 623 controls remained for analyses. Adjusted risk of bile duct injury was doubled among patients with acute cholecystitis (OR 1.97 95 % CI 1.05-3.72), whereas a mild acute cholecystitis (Tokyo grade I) did not affect the risk of bile duct injury (OR 0.96 95 % CI 0.41-2.25), a moderate (Tokyo grade II) more than doubled the risk (OR 2.41 95 % CI 1.21-4.80). Severe cholecystitis (Tokyo grade III) had a close to significant eightfold increase in risk (OR 8.43 95 % CI 0.97-72.9). The intention to use intraoperative cholangiography reduced injury risk by 52 % (OR 0.48, 95 % CI 0.29-0.81). CONCLUSIONS: Patients with on-going acute cholecystitis had twice the risk of sustaining a biliary lesion compared to patients without acute cholecystitis. There was a relation between the Tokyo guidelines severity grading of acute cholecystitis and injury risk and the intention to use intraoperative cholangiography halved the risk of reconstructed bile duct injury during cholecystectomy.

Best practice in placement of percutaneous endoscopic gastrostomy with jejunal extension tube for continuous infusion of levodopa carbidopa intestinal gel in the treatment of selected patients with Parkinson's disease in the Nordic region.

OBJECTIVE: Continuous infusion of levodopa carbidopa intestinal gel (LCIG) is associated with a significant improvement in the symptoms and quality of life of selected patients with advanced Parkinson's disease. Percutaneous endoscopic gastrostomy with jejunal extension (PEG/J) was first described in 1998 and has become the most common and standard technique for fixing the tubing in place for LCIG infusion. MATERIAL AND METHODS: A workshop was held in Stockholm, Sweden, to discuss the PEG/J placement for the delivery of LCIG in Parkinson's disease patients with the primary goal of providing guidance on best practice for the Nordic countries. RESULTS: Suggested procedures for preparation of patients for PEG/J placement, aftercare, troubleshooting and redo-procedures for use in the Nordic region are described and discussed. CONCLUSIONS: LCIG treatment administered through PEG/J-tubes gives a significant increase in quality of life for selected patients with advanced Parkinson's disease. Although minor complications are common, serious complications are infrequent, and the tube insertion procedures have a good safety record. Further development of delivery systems and evaluation of approaches designed to reduce the demand for redo endoscopy are required.

ERCP-guided cholangioscopy using a single-use system: nationwide register-based study of its use in clinical practice.

BACKGROUND AND STUDY AIMS: Single-operator peroral cholangioscopy enables direct visualization of duct lesions, biopsy, and therapeutic interventions in the biliary and pancreatic ductal systems. The aim of this study was to address the use and outcome of this technology in wider clinical practice. PATIENTS AND METHODS: A nationwide study of endoscopic retrograde cholangiopancreatography (ERCP) procedures, with or without cholangioscopy, was conducted. Procedures that were registered in the Swedish Registry for Gallstone Surgery and ERCP (GallRiks), between 2007 and 2012 were included. The primary outcome was ERCP-specific adverse events. RESULTS: Data from 36 352 ERCP procedures were analyzed, including 408 cholangioscopy procedures. Postprocedural adverse events were more prevalent when cholangioscopy was used (19.1 % vs. 14.0 %). Pancreatitis (7.4 % vs. 3.9 %) and cholangitis (4.4 % vs. 2.7 %) were ERCP-specific adverse events that were elevated in the cholangioscopy group. However, in multivariate analysis, the risks of intraprocedural and postprocedural adverse events were significantly increased in the cholangioscopy group whereas the risks of pancreatitis and cholangitis, when adjusted for confounders, were not. CONCLUSION: The single-operator peroral cholangioscopy technique is an advanced technique for intraluminal visual inspection, and for therapeutic intervention of the biliary and pancreatic ducts. However, there is a significantly increased risk of intra- and postprocedural adverse events. Thus, this method should preferably be performed at tertiary referral centers in carefully selected patients.

The role of antibiotic prophylaxis in routine endoscopic retrograde cholangiopancreatography investigations as assessed prospectively in a nationwide study cohort.

OBJECTIVE: Risk factors for complications after endoscopic retrograde cholangiopancreatography (ERCP) with emphasis on the potential advantage of the use of prophylactic antibiotics were studied in a national population-based study cohort. MATERIALS AND METHODS: All ERCP procedures registered in the Swedish Registry of Gallstone Surgery and ERCP (GallRiks) between May 2005 and June 2013 were analyzed. Patients with ongoing antibiotic treatment, incomplete registration or those who had not undergone an index ERCP were excluded. Risk factors for adverse events were analyzed. RESULTS: Data from 47,950 ERCPs were collected, but after applying the exclusion criteria, 31,188 examinations were analyzed. In the group receiving prophylactic antibiotics, the postoperative adverse event rate was 11.6% compared with 14.2% in the group without antibiotics. The odds ratio (OR) for the risk of postoperative adverse events in patients receiving prophylactic antibiotics was 0.74 (95% confidence interval [CI]: 0.69-0.79). When analyzing a subgroup of 21,893 ERCPs for the three most common indications (common bile duct stones, malignancy, and obstructive jaundice), the beneficial effect of prophylactic antibiotics on adverse events remained (OR = 0.76; 95% CI: 0.70-0.82). Further, in the subgroup of patients with obstructive jaundice, the administration of prophylactic antibiotics had a beneficial effect on septic complications (OR = 0.76; 95% CI: 0.58-0.97). CONCLUSION: The risk of adverse events after ERCP is reduced 26% if antibiotics are given prophylactically during ERCP investigations, as suggested by data gained from this national population-based study. However, in absolute terms, the reduction in adverse events by prophylactic antibiotics is modest (2.6%).

Effect of intended intraoperative cholangiography and early detection of bile duct injury on survival after cholecystectomy: population based cohort study.

OBJECTIVES: To determine whether the routine use of intraoperative cholangiography can improve survival from complications related to bile duct injuries. DESIGN: Population based cohort study. SETTING: Prospectively collected data from the Swedish national registry of gallstone surgery and endoscopic retrograde cholangiopancreatography, GallRiks. Multivariate analysis done by Cox regression. POPULATION: All cholecystectomies recorded in GallRiks between 1 May 2005 and 31 December 2010. MAIN OUTCOME MEASURES: Evidence of bile duct injury, rate of intended use of intraoperative cholangiography, and rate of survival after cholecytectomy. RESULTS: During the study, 51,041 cholecystectomies were registered in GallRiks and 747 (1.5%) iatrogenic bile duct injuries identified. Patients with bile duct injuries had an impaired survival compared with those without injury (mortality at one year 3.9% v 1.1%). Kaplan-Meier analysis showed that early detection of a bile duct injury, during the primary operation, improved survival. The intention to use intraoperative cholangiography reduced the risk of death after cholecystectomy by 62% (hazard ratio 0.38 (95% confidence interval 0.31 to 0.46)). CONCLUSIONS: The high incidence of bile duct injury recorded is probably from GallRiks' ability to detect the entire range of injury severities, from minor ductal lesions to complete transections of major ducts. Patients with bile duct injury during cholecystectomy had impaired survival, and early detection of the injury improved survival. The intention to perform an intraoperative cholangiography reduced the risk of death after cholecystectomy.

Long-term effects of iatrogenic bile duct injury during cholecystectomy.

BACKGROUND & AIMS: The aim of this study was to study survival, factors influencing survival, and causes of death after iatrogenic reconstructed bile duct injury in a large population-based Swedish cohort. METHODS: Patients who underwent cholecystectomy in the period from 1965 to 2005 were identified from the Swedish Inpatient Register. The bile duct injury cohort consisted of patients with procedure codes indicating reconstructive biliary surgery within 1 year of the cholecystectomy, excluding patients with reconstruction owing to other causes than bile duct injury. RESULTS: Of 374,042 cholecystectomy patients, 1386 were classified as afflicted by bile duct injury requiring reconstructive surgery. Survival was significantly lower in the injured cohort compared with the noninjured cohort, with a hazard ratio of 3.73 (95% confidence interval, 3.30-4.22) at 1 year that gradually evened out thereafter. The risk of dying from liver diseases was increased 4-fold in the bile duct injury cohort compared with the general population. Older age and comorbidity increased the risk of dying, whereas the use of intraoperative cholangiogram improved survival. CONCLUSIONS: Patients with iatrogenic reconstructed bile duct injury have a decreased survival rate compared with noninjured cholecystectomy patients. Patients' younger age, absence of other diseases, and routine use of intraoperative cholangiogram seem to be positive prognostic survival factors. These patients also may be at increased risk of dying from liver diseases, although this issue requires further study.