Clinical features and distribution of the APC variant in duodenal and ampullary polyps in patients with familial adenomatous polyposis: a multicenter retrospective cohort study in Japan.

BACKGROUND: Management of duodenal or ampullary adenomas in patients with familial adenomatous polyposis (FAP) is a major challenge for clinicians. Insufficient data are available to evaluate the clinical manifestations and distribution of adenomatous polyposis coli (APC) variants in these patients. METHODS: We enrolled 451 patients with data regarding duodenal or ampullary polyps from 632 patients with FAP retrospectively registered in a nationwide Japanese multicenter study. Clinicopathological features and distribution of APC variants were compared between patients with and without duodenal or ampullary polyps. RESULTS: Duodenal and ampullary polyps were found in 59% and 18% of patients with FAP, respectively. The incidence of duodenal cancer was 4.7% in patients with duodenal polyps, and that of ampullary cancer was 18% in patients with ampullary polyps. Duodenal polyps were significantly associated with the presence of ampullary polyps and jejunal/ileal polyps. Duodenal polyps progressed in 35% of patients with a median follow-up of 776 days, mostly in those with early Spigelman stage lesions. Ampullary polyps progressed in 50% of patients with a follow-up of 1484 days. However, only one patient developed a malignancy. The proportion of patients with duodenal polyps was significantly higher among those with intermediate- or profuse-type APC variants than attenuated-type APC variants. The presence of duodenal polyps was significantly associated with ampullary and jejunal/ileal polyps in patients with intermediate- or profuse-type APC variants. CONCLUSIONS: Periodic endoscopic surveillance of the papilla of Vater and small intestine should be planned for patients with FAP with duodenal polyps.

Personal comorbidities and their subsequent risks for liver, gallbladder and bile duct cancers.

Many environmental risk factors for hepatobiliary cancers are known but whether they are associated with specific cancer types is unclear. We present here a novel approach of assessing standardized incidence ratios (SIRs) of previously diagnosed comorbidities for hepatocellular carcinoma (HCC), gallbladder cancer (GBC), cholangiocarcinoma (CCA) and ampullary cancer. The 13 comorbidities included alcohol and nonalcohol related liver disease, chronic obstructive pulmonary disease, gallstone disease, viral and other kinds of hepatitis, infection of bile ducts, hepatic and other autoimmune diseases, obesity and diabetes. Patients were identified from the Swedish Inpatient Register from 1987 to 2018, and their cancers were followed from 1997 onwards. SIRs for HCC were 80 to 100 in men and women diagnosed with hepatitis C virus and they were also >10 in patients diagnosed with hepatitis B virus, other kind of hepatitis, hepatic autoimmune disease and nonalcohol related liver disease. Many of these risks, as well as alcohol related liver disease, were either specific to HCC or were shared with intrahepatic CCA. For GBC, CCA and ampullary cancer infection of bile ducts was the main risk factor. Gallstone disease, nonhepatic autoimmune diseases and diabetes were associated with all hepatobiliary cancers. The limitations of the study include inability to cover some rare risk factors and limited follow-up time. Many of the considered comorbidities are characterized by chronic inflammation and/or overt immune disturbance in autoimmune diseases. The results suggest that local chronic inflammation and a related immune disturbance is the carcinogenic trigger for all these cancers.

EUS-guided gallbladder drainage using a lumen-apposing metal stent as rescue treatment for malignant distal biliary obstruction: a large multicenter experience.

BACKGROUND AND AIMS: EUS-guided gallbladder drainage (EUS-GBD) with lumen-apposing metal stents (LAMSs) has been reported as a rescue treatment with encouraging results for the relief of jaundice in patients with distal malignant biliary obstruction (DMBO) and after failure of both ERCP and EUS-guided choledochoduodenostomy. METHODS: This was a multicenter retrospective analysis of all cases of consecutive EUS-GBD with LAMSs used as a rescue treatment for patients with DMBO in 14 Italian centers from June 2015 to June 2020. Primary endpoints were technical and clinical success, whereas the secondary endpoint was the adverse event (AE) rate. RESULTS: Forty-eight patients (52.1% women) with a mean age of 74.3 ± 11.7 years were included in the study. Biliary stricture was related to pancreatic adenocarcinoma (85.4%), duodenal adenocarcinoma (2.1%), cholangiocarcinoma (4.2%), ampullary cancer (2.1%), colon cancer (4.2%), and metastatic breast cancer (2.1%). The mean diameter of the common bile duct was 13.3 ± 2.8 mm. LAMSs were placed transgastrically in 58.3% of cases and transduodenally in 41.7%. Technical success was 100%, whereas clinical success was 81.3%, with a mean total bilirubin reduction after 2 weeks of 66.5%. The mean procedure time was 26.4 minutes, and the mean hospital stay was 9.2 ± 8.2 days. AEs occurred in 5 patients (10.4%): 3 were classified as intraprocedural and 2 were classified as delayed because they occurred after >15 days. When the American Society for Gastrointestinal Endoscopy lexicon was used, 2 AEs were mild and 3 were moderate (2 buried LAMSs). The mean follow-up was 122 days. CONCLUSIONS: Our study shows that EUS-GBD with LAMSs used as a rescue treatment for patients affected by DMBO represents a valuable option in terms of technical and clinical success rates, with an acceptable AE rate. To the best of our knowledge, this is the largest study concerning the use of this procedure. (Clinical trial registration number: NCT03903523.).

EUS-guided choledochoduodenostomy for malignant distal biliary obstruction after failed ERCP: a retrospective nationwide analysis.

BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CDS) with a lumen-apposing metal stent (LAMS) has been proposed as an alternative procedure in patients with distal malignant biliary obstruction (DMBO) and failed ERCP. METHODS: This multicenter, retrospective analysis included all cases of EUS-CDS with LAMS performed in patients with DMBO and failed ERCP in 23 Italian centers from January 2016 to July 2020. Primary endpoints were technical and clinical success. Secondary endpoints were the assessment of the adverse event (AE) rate and variables associated with technical success. RESULTS: Two hundred fifty-six patients (44.9% women) with a mean age of 73.9 ± 12.6 years were included in the study. The most common etiology of DMBO was pancreatic adenocarcinoma (75%), followed by ampullary cancer (8.6%) and cholangiocarcinoma (6.6%). The common bile duct median diameter was 17.3 ± 3.9 mm. Technical and clinical success were achieved in 239 of 256 (93.3%), and 230 of 239 (96.2%) patients, respectively. The mean follow-up was 151 ± 162 days. Twenty-seven AEs occurred in 25 of 239 patients (10.5%) (3 mild, 21 moderate, and 3 severe). No fatal AEs occurred. Reinterventions to manage AEs with endoscopic or radiologic procedures occurred in 22 patients (9.2%). CONCLUSIONS: The results of our study show that EUS-CDS with LAMSs in patients with DMBO and failed ERCP represent a viable alternative in terms of effectiveness and safety with acceptable AE rates. (Clinical trial registration number: NCT03903523.).

Natural history of ampullary adenomas in familial adenomatous polyposis: a long-term follow-up study.

BACKGROUND AND AIMS: Ampullary adenomas (AAs), common in familial adenomatous polyposis (FAP), are precursors to ampullary carcinoma. We assessed the natural history of AAs and factors associated with clinically significant progression (CSP). METHODS: Consecutive FAP patients with AAs and at least 2 EGDs were identified from a hereditary GI cancer registry. We assessed the incidence of CSP (increase in size to ≥10 mm and/or development of advanced histology) of AAs. Clinical, endoscopic, and pathologic features between patients with CSP and nonprogressors were compared. RESULTS: One hundred forty-three patients with AAs were included. Over a median follow-up of 7.8 years (interquartile range, 4.3-11.1), 41 patients (28.6%) developed CSP for an incidence of 35 per 1000 patient-years. Of 143 patients, 22 (15.6%) progressed to AAs ≥10 mm, 12 (8.5%) progressed to advanced histology, and 7 (4.9%) progressed both in size and histology. Two patients (1.4%) developed ampullary cancer. Male gender, abnormal appearance of the papilla at initial AA detection, prior cholecystectomy, and personal history of extracolonic malignancy were associated with CSP. Neither Spigelman stage nor the adenomatous polyposis coli gene pathogenic variants were associated with CSP. An intervention specifically for AA and not duodenal polyposis was performed in 24% of patients with AAs, including endoscopic papillectomy in 23 patients and duodenectomy in 3 patients at a median observation of 8.2 years. CONCLUSIONS: Most FAP patients with AAs did not experience CSP or require resection over 8 years of surveillance. Ampullary cancer was rare. Male gender, abnormal appearance of the papilla at AA detection, cholecystectomy, and history of extracolonic malignancy were associated with CSP. Our findings favor endoscopic surveillance of AAs over expedited resection for most patients with FAP.

Carcinosarcoma of the extrahepatic bile duct: an unusual cause of obstructive jaundice.

In relation to the article published in this journal by Guzmán describing a case of ampulla of Vater carcinosarcoma, we present a case of extrahepatic bile duct carcinosarcoma. A neoplasm described in different anatomical locations with an exceptional origin in the bile duct.

[Management of obstructive jaundice in patients with neoplasms of the major duodenal papilla]. / Taktika lecheniya mekhanicheskoi zheltukhi u patsientov s novoobrazovaniyami bol'shogo sosochka dvenadtsatiperstnoi kishki.

OBJECTIVE: To develop the indications and assess an effectiveness of treatment of patients with ampullary tumors followed by mechanical jaundice. MATERIAL AND METHODS: There were 26 patients with major duodenal papilla neoplasms for the period 2015-2020 at the Sklifosovsky Research Institute for Emergency Care. RESULTS: Twenty patients underwent transpapillary interventions: papillosphincterotomy followed by lithoextraction and bilio-duodenal stenting in 4 (15.3%) patients, bilio-duodenal stenting in 12 (46.1%) patients, nasobiliary drainage in 2 (7.6%) patients, pancreaticoduodenal stenting in 2 (7.6%) patients. Percutaneous transhepatic microcholecystostomy was performed in 6 (23.4%) patients. In all cases, laboratory values decreased in 5-7 days after drainage. Eight (30.7%) patients refused further surgical treatment and were discharged in satisfactory condition. Another 8 (44.5%) patients underwent endoscopic submucosal papillectomy. There were no postoperative complications. Patients were discharged after 5-7 days. Four (22.2%) patients underwent tumor resection via laparotomy. One of these patients required redo laparotomy in postoperative period due to acute perforated duodenal ulcer. Six (33.3%) patients underwent palliative bilio-duodenal stenting. CONCLUSION: Invasion of muscle layer or distal parts of the common bile duct, as well as abnormal vascularization are indications for open surgery or palliative endoscopic treatment. Tumor location within mucous and muscle layers without invasion of distal third of the common bile duct and no abnormal vascularization of tumor justify endoscopic papillectomy. Endoscopic approach can be considered as a final minimally invasive method with minimal risk of postoperative complications in case of benign ampullary tumor.

[Cancer of terminal part of common bile duct in a patient with heterotaxy syndrome]. / Rak terminal'nogo otdela obshchego zhelchnogo protoka u patsienta s sindromom geterotaksii.

Case report is devoted to successful pancreatectomy for cancer of terminal part of common bile duct in a patient with heterotaxy syndrome. The main difficulties during dissection of pancreaticoduodenal complex arose due to anatomical disorientation and the lack of standard topographic and anatomical landmarks. Preoperative computed tomography with assessment of visceral vessel anatomy is essential in all patients with biliopancreaticoduodenal tumors. If heterotaxy syndrome is suspected, additional examination is required to detect other potential abnormalities and prepare for unusual situation.

Single-stage EUS-guided choledochoduodenostomy using a lumen-apposing metal stent for malignant distal biliary obstruction.

BACKGROUND AND AIMS: EUS-guided choledochoduodenostomy (EUS-CD) using a lumen-apposing metal stent (LAMS) has recently been reported as an alternative treatment approach for patients with malignant obstructive jaundice and failed ERCP. We analyzed the safety and technical and clinical efficacy of EUS-CD using LAMSs in patients with malignant obstructive jaundice. METHODS: This was a retrospective study of consecutive patients with inoperable malignant distal bile duct obstruction who underwent EUS-CD using an electrocautery-enhanced (EC)-LAMS over a 3-year period (2015-2018). The main outcome measures were technical and clinical success (defined as a decline in serum bilirubin level by 50% at 2-week follow-up). Secondary outcomes were occurrence of adverse events, procedure time, and stent patency. RESULTS: Forty-six patients (47.8% women; median age, 73.1 ± 12.6 years) underwent direct EUS-CD using the biliary EC-LAMS. The procedure was technically successful in 43 patients (93.5%). The rate of clinical success was 97.7%. Adverse events occurred in 5 (11.6%) patients and included the following: 1 fatal bleeding 17 days after stent placement, 3 episodes of stent occlusion (food impaction), and 1 spontaneous migration (all 4 requiring reintervention). The mean follow-up was 114.37 days (95% confidence interval, 73.2-155.4). CONCLUSIONS: EUS-CD using the EC-LAMS is effective. The rate of adverse events including one fatal event is not negligible and should be carefully considered before using the stent in this clinical setting. Prospective studies are required to validate our preliminary findings to fully assess the long-term efficacy and safety of the stent.

Safety and efficacy of a metal stent covered with a silicone membrane containing integrated silver particles in preventing biofilm and sludge formation in endoscopic drainage of malignant biliary obstruction: a phase 2 pilot study.

BACKGROUND AND AIMS: Membrane-covered self-expandable metal stents (SEMSs) have been developed to prolong the patency of stents by reducing tissue hyperplasia or tumor ingrowth. However, their effectiveness is attenuated by stent clogging as a result of biofilm formation on the inner surface of the membrane. The aim of this pilot study was to evaluate the efficacy and safety of SEMSs covered with a silicone membrane containing integrated silver particles (Ag-P) in malignant distal biliary obstruction. METHODS: Twenty-four patients who underwent SEMS placement because of malignant distal biliary obstruction were enrolled in this single-center pilot study. The main outcomes were technical success, clinical success, adverse events, stent patency, and survival. RESULTS: The technical and clinical success rates were 100% and 91.7% (22 of 24), respectively. The rates of early and late adverse events were 22.7% and 36.4%, respectively. The primary reintervention rate was 27.3% (6 of 22). Only 1 case involving stent malfunction was associated with sludge impaction. Median stent patency was 179 days. During follow-up, there were no serious adverse events or mortality related to the stents or Ag-P. Serum and urine silver concentrations before and after stent placement and at 32 weeks after placement did not differ. All serum and urine silver concentrations were <3 µg/L (3 ppb) and 5 µg/L (5 ppb), respectively. CONCLUSIONS: SEMSs covered with a silicone membrane containing integrated Ag-Ps may be effective and safe in malignant distal biliary obstruction. Stent dysfunction related to sludge impaction may be less frequent using this new stent. (Clinical Research Information Service identifier: KCT 0002310.).

Ampullary cancer in a patient with familial adenomatous polyposis - a rare case report and current status of management.

Familial adenomatous polyposis (FAP) is an inherited autosomal dominant disorder. Extracolonic manifestations are seen quite often. As prophylactic colectomy has become a standard care in FAP patients, the concerns over the development of associated extracolonic malignancies have become more prevalent. The authors report a case of a patient with the history of subtotal colectomy because of FAP with the development of adenocarcinoma of papilla of Vater twenty-six years later. A radical procedure in form of proximal pancreaticoduodenectomy was indicated. Variable endoscopic surveillance protocols and treatment strategies have been proposed concerning the management of duodenal and periampullary lesions. In case of periampullary malignancies, the radical surgical resection offers the only chance for cure and the only option that may safeguard the long­term survival (Fig. 2, Ref. 30). Keywords: ampulla of Vater, bile duct, obstructive jaundice, pancreatoduodenectomy, periampullary tumors.

[Obstructive ictericia by neuroma of amputation of via biliar. Case report]. / Ictericia obstructiva por neuroma de amputación de vía biliar. Reporte de caso.

Neuromas of the bile duct develop from the sympathetic and parasympathetic nerve fibers that surround the wall of the bile duct. A 44-year-old woman with a history of conventional cholecystectomy six months prior to hospital admission attended emergency due to obstructive jaundice that lasted 15 days. In the imaging studies, the presence of a mass at the level of the bile ducts is considered, considering the diagnosis of a malignant neoplasm. Due to the antecedents, the absence of tumor markers, it was decided to perform a percutaneous biopsy without conclusive results, performing later a surgical intervention with anatomopathological study compatible with neuroma of biliary tract amputation. The amputation neuroma at the level of the bile duct is an infrequent tumor. It can manifest clinically as obstructive jaundice and usually simulates a malignant tumor of the bile ducts. Surgical management is the definitive treatment.

ERCP performed through previously placed duodenal stents: a multicenter retrospective study of outcomes and adverse events.

BACKGROUND AND AIMS: ERCP performed through previously placed enteral stents is an uncommon procedure without a significant amount of supporting literature and with a wide reported range of technical success. The purpose of this study was to evaluate and better define the technical feasibility and safety of performing ERCP through enteral stents in patients with combined malignant biliary and gastric outlet obstruction. METHODS: We conducted a multicenter, retrospective study on 71 patients with combined gastric outlet and biliary obstruction who underwent ERCP through a previously placed enteral stent at 2 tertiary care centers. Outcomes included but were not limited to technical success, clinical success, need for repeat ERCP, adverse events, and survival time. RESULTS: Overall technical success was achieved in 60 of 71 patients (85%), with technical success of 40 of 46 (87%) in type I obstructions (gastric outlet obstruction above the ampulla), 16 of 21 (76%) in type II obstructions (gastric outlet obstruction at the level of the ampulla), and 4 of 4 (100%) in type III obstructions (gastric outlet obstruction distal to the ampulla). In general, patients who achieved technical success also achieved clinical success. Adverse events occurred in 3 patients (3/71): 2 patients with acute cholangitis and 1 patient with perforation. Average survival time after the procedure was 4.6 months overall. CONCLUSIONS: ERCP performed through enteral stents is safe, with a high technical and clinical success rate, but may be more technically challenging in the setting of type II obstructions. This procedure could be considered first line in the unique setting that a patient requires ERCP through a previously placed enteral stent for malignant gastric outlet and biliary obstruction.

Efficacy of EUS-guided and ERCP-guided biliary drainage for malignant biliary obstruction: prospective randomized controlled study.

BACKGROUND AND AIMS: ERCP-guided biliary drainage (ERCP-BD) is a criterion standard treatment for malignant biliary obstruction when curative surgery is not an option. Alternative methods such as percutaneous transhepatic biliary drainage would significantly lower the quality of life. EUS-guided biliary drainage (EUS-BD) has been developed and performed by experienced endoscopists. Therefore, the aims of this study were to evaluate the efficacy and safety of EUS-BD compared with ERCP in malignant biliary obstruction. METHODS: The prospective randomized controlled study was conducted, and 30 patients were enrolled: 15 for each EUS-BD and ERCP-BD arms. The technical success, procedural time, clinical success, and adverse events were evaluated. RESULTS: Thirty patients had extrahepatic malignant biliary tract obstruction (19 men, 11 women). Twenty-seven patients had unresectable pancreatic ductal adenocarcinomas, 1 patient had distal common bile duct cancer, and 2 patients had metastatic malignant lymphadenopathy. There were no significant differences both in terms of technical success rate and clinical success rate (100% vs 93% and 93% vs 100% in ERCP-BD vs EUS-BD, respectively; P = 1.00, P = 1.00). Four patients (31%) had tumor ingrowth-caused stent dysfunction in the ERCP-BD group, whereas 2 patients had food impaction and 2 patients had stent migration in the EUS-BD group. No significant procedure-related adverse events occurred in either group. CONCLUSIONS: This prospective randomized controlled study suggests that EUS-BD has similar safety to ERCP-BD. EUS-BD was not superior to ERCP-BD in terms of relief of malignant biliary obstruction. EUS-BD may have fewer cases of tumor ingrowth but may also have more cases of food impaction or stent migration. (Clinical trial registration number: NCT01421836.).

Effect of preoperative biliary drainage on bacterial flora in bile of patients with periampullary cancer.

BACKGROUND: Patients with obstructive jaundice due to periampullary tumours may undergo preoperative biliary drainage (PBD). The effect of PBD on the microbiome of the biliary system and on postoperative outcome remains unclear. METHODS: A single-centre retrospective study of patients with obstructive jaundice due to periampullary cancer, treated between July 2007 and July 2015, was undertaken. Intraoperative bile samples were obtained for microbiological analysis after transection of the common bile duct. Postoperative complications were registered. RESULTS: Of 290 patients treated, intraoperative bile samples were present for 172 patients (59·3 per cent) who had PBD and 118 (40·7 per cent) who did not. Contamination of bile was increased significantly in patients who underwent stenting (97·1 per cent versus 18·6 per cent in those without stenting; P < 0·001). PBD resulted in a shift in the biliary microbiome from Escherichia coli in non-stented patients (45 per cent versus 19·2 per cent in stented patients; P = 0·009) towards increased contamination with Enterococcus faecalis (9 versus 37·7 per cent respectively; P = 0·008) and Enterobacter cloacae (0 versus 20·4 per cent; P = 0·033). This shift was associated with a high incidence of bacterial resistance against ampicillin-sulbactam (63·6 per cent versus 18 per cent in patients with no PBD; P < 0·001), piperacillin-tazobactam (30·1 versus 0 per cent respectively; P = 0·003), ciprofloxacin (28·5 versus 5 per cent; P = 0·047) and imipenem (26·6 versus 0 per cent; P = 0·011). The rate of wound infection was higher in patients with a positive bile culture (21·0 per cent versus 6 per cent in patients with sterile bile; P = 0·002). Regression analysis revealed the presence of Enterococcus faecium (odds ratio 2·83, 95 per cent c.i. 1·17 to 6·84; P = 0·021) and Citrobacter species (odds ratio 5·09, 1·65 to 15·71; P = 0·005) as independent risk factors for postoperative wound infection. CONCLUSION: There are fundamental differences in the biliary microbiome of patients with periampullary cancer who undergo PBD and those who do not. PBD induces a shift of the biliary microbiome towards a more aggressive and resistant spectrum, which requires a differentiated perioperative antibiotic treatment strategy.

Percutaneous transhepatic versus EUS-guided gallbladder drainage for malignant cystic duct obstruction.

BACKGROUND AND AIMS: Endoscopic ultrasound-guided gallbladder drainage (EUS-GBD) has been proposed as an alternative management strategy for acute cholecystitis caused by malignant cystic duct obstruction in patients for whom surgery is not an option. This study aimed to compare the results of EUS-GBD with those of percutaneous transhepatic gallbladder drainage (PTGBD) for palliative management of malignant cystic duct obstruction with acute cholecystitis or symptomatic gallbladder hydrops. METHODS: Between November 2013 and November 2015, 14 patients with acute cholecystitis or symptomatic gallbladder hydrops as a result of malignant cystic duct obstruction underwent EUS-GBD with covered metal stents. Nineteen patients with acute cholecystitis as a result of malignant cystic duct obstruction who received PTGBD served as a control group. Patients' medical records were reviewed retrospectively. RESULTS: The technical and clinical success rates of EUS-GBD were 85.7% (12/14) and 91.7% (11/12) and of PTGBD were 100% (19/19) and 86.4% (17/19), respectively. The groups had similar adverse event rates (28.5% and 21.1%, respectively). The average duration of stent patency in patients with EUS-GBD was 130.3 ± 35.3 days, and no patient required an additional procedure before death. In 6 of 17 patients (35.3%) with clinically successful PTGBD, the catheter was not removed until the end stage of life. CONCLUSIONS: EUS-GBD is a feasible, safe, and effective modality for the treatment of malignant cystic duct obstruction in patients who are not indicated for surgery. It enables improved long-term quality of life in patients with advanced-stage cancer.

Temporary placement of a covered duodenal stent can avoid riskier anterograde biliary drainage when ERCP for obstructive jaundice fails due to duodenal invasion.

BACKGROUND: Duodenal stenosis is one of the most common causes of failed ERCP for obstructive jaundice. Alternative approaches include anterograde biliary drainage, with higher morbidity. We report in this study the efficacy and safety of temporary placement of a covered duodenal self-expandable metal stent (cSEMS) in order to access the papilla and achieve secondary retrograde biliary drainage in patients with obstructive jaundice and failed ERCP due to concomitant duodenal stenosis. METHODS: From June 2006 to March 2014, a total of 26 consecutive patients presenting obstructive jaundice without severe sepsis with failed ERCP due to duodenal invasion were enrolled. A temporary 7-day duodenal cSEMS was placed during the failed ERCP, and a second ERCP was attempted at day 7 after duodenal stent removal. RESULTS: Duodenal cSEMS placement and retrieval were technically successful in all cases. Access to the papilla at day 7 was possible in 25 cases (96 %, 95 % CI 80-99 %). Secondary successful ERCP was achieved in 19 cases (76 %, 95 % CI 55-91 %, i.e., 73 %, 95 % CI 73-86 %, in an intention-to-treat analysis). Mean bilirubin level was 102 ± 90 µmol/L at baseline rising to 164 ± 121 µmol/L at day 7. There were 6 stent migrations and no adverse events recorded between the two ERCPs. CONCLUSIONS: When ERCP for obstructive jaundice fails due to duodenal invasion, temporary cSEMS placement offers a safe and effective way to achieve successful secondary ERCP while avoiding riskier endoscopic ultrasound or percutaneous transhepatic anterograde biliary drainage.