Hybrid Versus Conventional Colorectal Endoscopic Submucosal Dissection: A Multicenter Randomized Controlled Trial (Short-Endoscopic Submucosal Dissection).

INTRODUCTION: Hybrid endoscopic submucosal dissection (H-ESD), which utilizes ESD knife along with snare-based resection, has been developed to overcome the technical complexity of conventional ESD (C-ESD). The aim of this study was to compare the therapeutic outcomes of H-ESD vs C-ESD for nonpedunculated colorectal lesions ≥20 mm in size. METHODS: We conducted a multicenter randomized controlled trial to compare H-ESD and C-ESD (Short-ESD trial). Patients with colorectal lesions between 20 and 50 mm in size were randomly assigned (1:1) to H-ESD or C-ESD. Primary outcome was procedure time/speed. Secondary outcomes were en bloc and complete (R0) resection rates and adverse event rates. RESULTS: A total of 89 patients (median age 63 years; 49.3% women) with the median polyp size of 30 mm underwent H-ESD (n = 40) and C-ESD (n = 49). The mean procedure time of H-ESD was significantly shorter than that of C-ESD (41.1 ± 16.3 vs 54.3 ± 28.2 minutes; P = 0.007). The en bloc and R0 resection rates trended lower in the H-ESD vs C-ESD groups (77.5% vs 87.8%; P = 0.26% and 72.5% vs 79.6%; P = 0.46) without reaching statistical significance. Adverse event rate was similar between H-ESD and C-ESD (10% vs 8.2%; P = 1.00). DISCUSSION: Both H-ESD and C-ESD were safe and effective for resection of large colorectal lesions. H-ESD was associated with a shorter procedure time. H-ESD may represent a viable alternative to C-ESD, with the main advantage being easy applicability of a snare-based technique for colorectal lesions. Future studies are needed to further define the most suitable lesions for H-ESD, as to optimize efficiency and safety without compromising resection outcomes. ClinicaTrials.gov NCT NCT05347446.

Efficacy of Endoscopic Submucosal Dissection for Superficial Gastric Neoplasia in a Large Cohort in North America.

BACKGROUND & AIMS: Endoscopic submucosal dissection (ESD) is a widely accepted treatment option for superficial gastric neoplasia in Asia, but there are few data on outcomes of gastric ESD from North America. We aimed to evaluate the safety and efficacy of gastric ESD in North America. METHODS: We analyzed data from 347 patients who underwent gastric ESD at 25 centers, from 2010 through 2019. We collected data on patient demographics, lesion characteristics, procedure details and related adverse events, treatment outcomes, local recurrence, and vital status at the last follow up. For the 277 patients with available follow-up data, the median interval between initial ESD and last clinical or endoscopic evaluation was 364 days. The primary endpoint was the rate of en bloc and R0 resection. Secondary outcomes included curative resection, rates of adverse events and recurrence, and gastric cancer-related death. RESULTS: Ninety patients (26%) had low-grade adenomas or dysplasia, 82 patients (24%) had high-grade dysplasia, 139 patients (40%) had early gastric cancer, and 36 patients (10%) had neuroendocrine tumors. Proportions of en bloc and R0 resection for all lesions were 92%/82%, for early gastric cancers were 94%/75%, for adenomas and low-grade dysplasia were 93%/ 92%, for high-grade dysplasia were 89%/ 87%, and for neuroendocrine tumors were 92%/75%. Intraprocedural perforation occurred in 6.6% of patients; 82% of these were treated successfully with endoscopic therapy. Delayed bleeding occurred in 2.6% of patients. No delayed perforation or procedure-related deaths were observed. There were local recurrences in 3.9% of cases; all occurred after non-curative ESD resection. Metachronous lesions were identified in 14 patients (6.9%). One of 277 patients with clinical follow up died of metachronous gastric cancer that occurred 2.5 years after the initial ESD. CONCLUSIONS: ESD is a highly effective treatment for superficial gastric neoplasia and should be considered as a viable option for patients in North America. The risk of local recurrence is low and occurs exclusively after non-curative resection. Careful endoscopic surveillance is necessary to identify and treat metachronous lesions.

Type II achalasia is associated with a comparably favorable outcome following per oral endoscopic myotomy.

Per oral endoscopic myotomy (POEM) is a safe and effective treatment for esophageal motility disorder in treatment-naïve patients as well as salvage therapy. Though type II achalasia, compared to other subtypes, is reported to have a more favorable outcome with pneumatic dilation (PD) or Heller myotomy (HM), it is unclear whether achalasia subtype predicts symptom response to POEM. We aimed to evaluate whether type II achalasia is associated with a comparably favorable outcome following POEM. We performed a retrospective review of patients with esophageal motility disorder who were referred for POEM from April 2014 to June 2017. The main outcome was clinical success based on Eckardt score ≤3 and its association with subtype and safety. A total of 63 patients (mean age 51 years [SD 15]; 63% male) underwent a total of 68 POEMs with median of 263 days follow-up. Of these, 45 (71.3%) patients were type II achalasia. In all, 29 (46%) patients were treatment-naïve and 34 (54%) patients had previous endoscopic or surgical therapy including botulinum toxin injection in 16 (25%), PD in 10 (16%), both botulinum toxin injection and PD in 8 (13%) and HM in 3 (5%). Technical success was 100% and clinical success was achieved in 51 (81%) patients. The rate of clinical success was higher in patients with type II achalasia compared to the other subtypes (88.9% vs. 61.1% [P = 0.028]) and type II achalasia patients required fewer redo POEM (2.2% vs. 22.2% [P = 0.021]). Multivariate logistic regression analysis demonstrated the positive prediction of clinical success for type II achalasia following POEM (P = 0.046). As observed with PD and HM, type II achalasia was associated with a favorable clinical outcome following POEM.

Family history of colorectal cancer and prevalence of advanced colorectal neoplasia in asymptomatic screened populations in different age groups.

BACKGROUND AND AIMS: The clinical significance of a family history (FH) of colorectal cancer (CRC) in first-degree relatives (FDRs) in CRC screening stratified by different age groups of screened individuals is not fully understood. We investigated the relationship between FH and the presence of advanced colorectal neoplasia (ACN) in screened individuals in different age groups. METHODS: Data from screened individuals aged 40 to 54 years (n = 2263) and 55 to 69 years (n = 2621) who underwent their first-ever screening colonoscopy were analyzed. The relationship between FH and ACN was examined, and a multivariate logistic regression analysis incorporating other baseline characteristics was performed. RESULTS: Among individuals aged 40 to 54 years, the prevalence of ACN was significantly higher in 249 individuals with affected FDRs than in those without (5.6% vs 1.6%; P < .01), with an adjusted odds ratio of 3.7 (95% confidence interval, 1.9-7.0; P < .01); the prevalence was particularly high in those having FDRs with CRC mortality (7.3%). Among individuals aged 55 to 69 years, the prevalence of ACN was not significantly different between 291 individuals with affected FDRs and those without (5.8% vs 5.8%; P = .95); however, individuals with 2 FDRs with CRC and mortality showed a high prevalence of ACN (17.4% and 42.9%, respectively). CONCLUSIONS: An FH of CRC in FDRs was associated with a higher prevalence of ACN in younger individuals, with a particularly high impact of FH of CRC mortality. In contrast, the impact of FH was weaker in older individuals except those having 2 FDRs with CRC or mortality.

Per oral endoscopic myotomy as salvage therapy in patients with achalasia refractory to endoscopic or surgical therapy is technically feasible and safe: Systematic review and meta-analysis.

BACKGROUNDS AND AIMS: Per oral endoscopic myotomy (POEM) has been reported as an effective and safe salvage therapy for achalasia but there is limited composite data. We performed a systematic review and meta-analysis of studies that reported the rates of clinical success and adverse events among patients who underwent POEM after failed conventional endoscopic or surgical therapy. METHODS: Electronic literature search was conducted from inception through December 2018 for articles reporting the efficacy and safety of POEM in patients with achalasia who failed endoscopic or surgical therapy. Primary outcome was the pooled estimated rates of clinical success, defined as Eckardt score ≤ 3 after POEM. Secondary outcomes were procedural time, the rates of POEM-related gastroesophageal reflux disease (GERD) and procedure-related adverse events. RESULTS: Seven studies reporting outcomes on 487 patients met our criteria. Pooled estimated rate of clinical success of POEM was 88% (95% confidence interval (CI) 79-94%). Mean procedural time was 64 minutes (95% CI 44-85 minutes). POEM-related GERD was found in 20% (95% CI 16-24%) of patients. Estimated incidence of overall adverse events was 10% (95% CI 5-18%) with individual risk of bleeding, mucosotomy, pneumothorax, pneumoperitoneum hydrothorax/mediastinitis, and subcutaneous emphysema ranging from 1 to 4%. CONCLUSIONS: Per oral endoscopic myotomy after failed endoscopic or surgical therapy in patients with achalasia is an effective and safe treatment. Further long-term follow-up studies in a larger number of patients are warranted to validate the sustainable efficacy of POEM for achalasia.

Low Frequency of Lymph Node Metastases in Patients in the United States With Early-stage Gastric Cancers That Fulfill Japanese Endoscopic Resection Criteria.

BACKGROUND & AIMS: In the West, early gastric cancer is increasingly managed with endoscopic resection (ER). This is, however, based on the assumption that the low prevalence and risk of lymph node metastases observed in Asian patients is applicable to patients in the United States. We sought to evaluate the frequency of and factors associated with metastasis of early gastric cancers to lymph nodes, and whether the Japanese ER criteria are applicable to patients in the US. METHODS: We performed a retrospective study of 176 patients (mean age 68.5 years; 59.1% male; 58.5% white) who underwent surgical resection with lymph node dissection of T1 and Tis gastric adenocarcinomas, staged by pathologists, at 7 tertiary care centers in the US from January 1, 1999, through December 31, 2016. The frequency of lymph node metastases and associated risk factors were determined. RESULTS: The mean size of gastric adenocarcinomas was 23.0 ± 16.6 mm-most were located in the lower-third of the stomach (67.0%), invading the submucosa (55.1%), and moderately differentiated (31.3%). Lymphovascular invasion was observed in 18.2% of lesions. Overall, 20.5% of patients had lymph node metastases. Submucosal invasion (odds ratio, 3.9; 95% CI, 1.4-10.7) and lymphovascular invasion (odds ratio, 4.6; 95% CI, 1.8-12.0) were independently associated with increased risk of metastasis to lymph nodes. The frequency of lymph node metastases among patients fulfilling standard and expanded Japanese criteria for ER were 0 and 7.5%, respectively. CONCLUSIONS: The frequency of lymph node metastases among patients with early gastric cancer in a US population is higher than that of published Asian series. However, early gastric cancer lesions that meet the Japanese standard criteria for ER are associated with negligible risk of metastasis to lymph nodes, so ER can be recommended for definitive therapy. Expanded criteria cancers appear to have a higher risk of metastasis to lymph nodes, so ER may be considered for select cases.

Incidence of Advanced Colorectal Neoplasia in Individuals With Untreated Diminutive Colorectal Adenomas Diagnosed by Magnifying Image-Enhanced Endoscopy.

OBJECTIVES: Because of the increasing number of detected diminutive colorectal adenomas, the "diagnose-and-do-not-resect" approach has recently attracted attention as an alternative to resection. We evaluated the cumulative incidence of advanced colorectal neoplasia (ACN) in individuals with untreated diminutive adenomas and compared this incidence in individuals without adenomas. METHODS: Data from 1,378 individuals who underwent first screening colonoscopy (CS) and at least one follow-up CS without polypectomy were analyzed. Patients with no adenomas or with only nonadvanced diminutive adenomas (<5 mm) diagnosed by magnifying image-enhanced endoscopy were scheduled to undergo a follow-up CS within 5 years after the initial CS without treatment. The participants were divided into 2 groups: those with untreated diminutive adenomas (group A) and those with no adenomas (group B). The cumulative incidence of ACN and the hazard ratio were assessed using Gray's test and the Fine and Gray model. RESULTS: During the median follow-up period of 60.9 months, 21 ACNs were detected. The 5-year cumulative incidences of ACN in group A (n = 361) and group B (n = 1,017) were 1.4% (95% confidence interval [CI]: 0.5-3.4) and 0.8% (95% CI: 0.3-1.7), respectively, without a statistically significant difference (P = 0.23). No ACNs developed from unresected adenomas. The smoking status was significantly associated with the incidence of ACN, and the hazard ratio for ACN in group A vs group B adjusted for smoking status was 1.43 (95% CI: 0.52-3.90; P = 0.48). DISCUSSION: The low 5-year cumulative incidence of ACN suggests the potential to adopt the "diagnose-and-do-not-resect" strategy as an alternative option for diminutive adenomas not requiring excessive surveillance.

EUS-guided fiducial placement for GI malignancies: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Image-guided radiotherapy (IGRT) allows the delivery of radiation with high precision to a target lesion while minimizing toxicity to surrounding tissues. EUS provides excellent visualization of GI tumors and consequently is being used for fiducial placement with increased frequency. Our goal was to perform a systematic review and meta-analysis of studies evaluating the technical aspects, safety, and efficacy of EUS fiducial placement for IGRT in GI malignancies. METHODS: A systematic literature search was carried out in the following databases: Medline, PubMed, Embase, Web of Science, and Cochrane Library, using Medical Subject Headings terms combined with text words. A random effects model was used to determine pooled proportions of technical success, migration, and adverse event rates. Heterogeneity was assessed using the I2 statistic. Publication bias was assessed visually using a funnel plot and by the Begg and Egger tests. RESULTS: Nine full articles and 5 abstracts reporting on 1155 patients, 49% from a single study by Dhadham et al, were included in the meta-analysis. The pooled rate of technical success was 98% (95% confidence interval [CI], 96-99). Moderate heterogeneity (I2 = 34.18) was present, which appeared to be due to variable sample sizes. Publication bias was present, suggesting that studies with less-substantial outcomes may have not been reported (Begg test, P = .87; Egger test, P < .01). Pooled rates for fiducial migration and adverse events were 3% (95% CI, 1.0-8.0) and 4% (95% CI, 3-7), respectively. CONCLUSIONS: Our meta-analysis showed that EUS-guided insertion of gold fiducials for IGRT is technically feasible and safe. Further controlled studies assessing its long-term effectiveness in GI malignancies are needed.

Clinical outcome of EMR of sporadic, nonampullary, duodenal adenomas: a 10-year retrospective.

BACKGROUND AND AIMS: Sporadic non-ampullary duodenal adenomas (SNADAs), although uncommon, pose clinical challenges. Because SNADAs have malignant potential, endoscopic or surgical resection is generally recommended. EMR is increasingly used for resection of SNADAs, but large-scale data on natural history after EMR are scarce. In this study, we aimed to evaluate the clinical outcome of EMR for SNADAs and the natural history after EMR from a large, single-operator experience with dedicated follow-up. METHODS: We performed a retrospective review of patients with SNADAs who were referred for endoscopic therapy from May 2007 to May 2016. Patient demographics, lesion characteristics, and procedural technical data were collected. The outcomes studied were complete endoscopic resection, major adverse events, and recurrence. RESULTS: A total of 162 patients were referred for endoscopic therapy, and 142 (88%) (median age 67 years, interquartile range [IQR] 57-73 years, 42% male) underwent a total of 166 EMRs with the use of a submucosal injection and thermal snare resection technique. In per-patient analysis, the median size of SNADAs was 20 mm (IQR 15-30) in diameter. Complete mucosal resection was achieved in 130 of 142 patients (92%). Local or residual recurrences were observed in 23% of patients (median time until recurrence 277 days [IQR 196-591]) and were treated endoscopically. No metachronous recurrences were found within a median follow-up of 363 days. In per-procedure analysis, en bloc resection was achieved in 88 (53%). EMR-related bleeding occurred in 18 (11%) EMRs, and all cases were successfully managed with supportive and/or endoscopic measures. No perforations occurred. Increasing size of adenomas was associated with recurrence (P < .001). No association with recurrence was noted with endoscopic or histologic features. Increasing size of resected specimens (P < .001) was associated with an increased risk of bleeding. CONCLUSION: EMR of most SNADAs can be performed safely and effectively. Increasing size of adenomas was associated with recurrence and bleeding after EMR. No association with recurrence was noted with endoscopic or histologic features. Focal recurrence can be managed with additional endoscopic therapy. Metachronous lesions do not occur. The findings inform directed management and surveillance.

Efficacy of Pharmacologic Therapy for Eosinophilic Esophagitis: A Systematic Review and Network Meta-Analysis.

GOALS: In order to provide a comparative evaluation of available pharmacologic treatments for eosinophilic esophagitis (EoE), we conducted a network meta-analysis. BACKGROUND: A variety of pharmacologic treatments for EoE have been reported, however there exists a paucity of direct comparisons. STUDY: We searched randomized controlled trials using MEDLINE, EMBASE, and Cochrane Central Register of Controlled Trials database through December 2014. Studies were analyzed using a random-effects network meta-analysis to identify the most effective therapy. Subgroup analysis was performed among studies that excluded gastroesophageal reflux disease or proton-pump inhibitor responsive esophageal eosinophilia, and also among pediatric and adult populations. The ranking probability for the efficacy of each treatment was analyzed. Consistency of the included randomized controlled trials was checked by applying inconsistency and node-splitting models. RESULTS: Eleven studies of a total of 456 patients were identified. Six pharmacologic treatments (budesonide suspension and viscous, fluticasone, prednisone, esomeprazole, and mepolizumab) and placebo were included in our analysis. Meta-analysis showed superiority of budesonide viscous, budesonide suspension, and fluticasone over placebo. Network meta-analysis demonstrated the rank order of efficacy as budesonide viscous, esomeprazole, prednisone, budesonide suspension, fluticasone, mepolizumab, and placebo. The results were consistent from the inconsistency model analysis and node-splitting analysis. Subgroup analysis demonstrated prednisone, budesonide suspension, and esomeprazole were the most effective when network meta-analyses were performed among studies that excluded gastroesophageal reflux disease or proton-pump inhibitor responsive esophageal eosinophilia, and among pediatric and adult populations, respectively. CONCLUSIONS: On the basis of this network meta-analysis, viscous budesonide was shown to be the most effective pharmacologic therapy for EoE among the reported pharmacologic treatments.

Efficacy, Durability, and Safety of Complete Endoscopic Mucosal Resection of Barrett Esophagus: A Systematic Review and Meta-Analysis.

GOALS: To report the rate of eradication and recurrence of both neoplasia and intestinal mucosa and the rate of adverse events for complete endoscopic resection (CER) of Barrett esophagus (BE). BACKGROUND: There is limited composite data on the clinical efficacy of CER of BE with high-grade dysplasia or neoplasia. STUDY: We performed a systematic review and meta-analysis of cohort studies that reported the clinical outcome of patients with BE who underwent CER and had at least 15-month follow-up after the time of elimination of BE. Main outcome of interests were pooled estimated rates of complete eradication of intestinal metaplasia and neoplasia, recurrence of intestinal metaplasia and neoplasia, and incidence of esophageal stricture, bleeding, and perforation. RESULTS: We identified 8 studies reporting on 676 patients (high-grade dysplasia 54%) that met our criteria. Pooled estimated rates of complete eradication of intestinal metaplasia and complete eradication of intestinal neoplasia were 85.0% [95% confidence interval (CI), 79.4%-89.2%] and 96.6% (95% CI, 94.0%-98.1%), respectively, and rates of recurrence of intestinal metaplasia and recurrence of intestinal neoplasia were 15.7% (95% CI, 8.0%-28.4%) and 5.8% (95% CI, 3.9%-8.6%), respectively. Estimated incidences of adverse events were stricture 37.4 (95% CI, 24.4%-52.6%), bleeding 7.9% (95% CI, 4.4%-13.8%) and perforation 2.3% (95% CI, 1.3%-4.1%). CONCLUSIONS: CER achieves an 85% complete eradication rate of BE with recurrent rate of neoplasia of 6%. Estimated rate of postprocedural stricture was 37.4%. On the basis of this high rate of adverse events and significant heterogeneity in the studies included, the present meta-analysis cannot endorse CER as sole therapy for BE.

Preoperative Right-Sided Cardiac Congestion Is Associated with Gastrointestinal Bleeding in Patients with Continuous-Flow Left Ventricular Assist Devices.

BACKGROUND: Large scale data on preoperative risk stratification for gastrointestinal bleeding (GIB) following continuous-flow left ventricular assist device (CF-LVAD) implantation are scarce. AIMS: To identify independent predictors for GIB following CF-LVAD implantation. METHODS: We conducted a retrospective cohort study of consecutive 243 patients who underwent CF-LVAD implantation (HeartMateII) from January 2009 to March 2015 at the University of Chicago Medical Center. GIB was defined as the presence of overt bleeding or occult GIB with ≥ 2 g/dl drop in hemoglobin (Hgb) from recorded baseline values and hemoccult-positive stool. The preoperative and postoperative data were reviewed. RESULTS: Within a median follow-up duration of 408 (IQR 113-954) days, 83 (34%) patients developed GIB after a median of 149 (IQR 27-615) days after implantation of CF-LVAD. There were no significant differences between the groups of GIB and non-GIB with respect to preoperative demographics and comorbidity except for ethnicity. The source of bleeding was identified in 39 (47%) patients and arteriovenous malformation or submucosal streaming vessel was the most frequent cause of bleeding (18/39, 46%). Multivariate-adjusted analysis demonstrated preoperative central venous pressure (CVP) ≥ 18 mmHg (HR 3.56; 95% CI 1.16-10.9; p = 0.026), mean pulmonary artery pressure (mPA) ≥ 36 mmHg (HR 4.14; 95% CI 1.35-12.7; p = 0.013), and the presence of moderate/severe tricuspid valve disease (HR 1.01; 95% CI 1.01-3.86; p = 0.046) were associated with the risk of GIB. CONCLUSIONS: In this study, preoperative right-sided cardiac congestion (i.e., increased CVP, mPA and the presence of moderate/severe tricuspid valve disease) was associated with GIB in patients with CF-LVAD.

Enhanced mucosal imaging and the esophagus--ready for prime time?

Innovation of endoscopic technology has recently been introduced to improve real-time visualization of mucosal architecture and subepithelial vascular structures. Since the esophagus is easily accessible using endoscopy and the length of required observation is limited, many different types of new imaging modalities have been reported and showing promising data. Early detection of neoplastic changes in the esophagus is devoted to the treatment in early stage cancer and theoretically leads to better prognosis. This review will focus on the emerging endoscopic technologies for the management of esophageal cancer.

Single balloon enteroscopy (SBE) assisted therapeutic endoscopic retrograde cholangiopancreatography (ERCP) in patients with roux-en-y anastomosis.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) in patients with Roux-en-Y anastomosis is a complex challenge. Long length of afferent limb after an acute angle at the jejunojejunostomy and altered location of the biliary orifice make biliary cannulation difficult. Single balloon enteroscopy assisted ERCP (SBE-ERCP) is a promising alternative to conventional approaches. AIM: The purpose of this study was to assess the efficacy and safety of SBE-ERCP in patients with Roux-en-Y reconstruction at a high volume tertiary referral center. METHODS: This is a retrospective cohort study. All procedures were performed by a single, experienced pancreatobiliary endoscopist. Patient demographics and related clinical data were obtained. The rate of procedure successes and complications were determined. RESULTS: Fourteen patients (nine women) with a median age of 63 years (range 35-83 years) underwent 22 SBE-ERCP procedures from March 2009 to May 2011. Surgically altered anatomy consisted of Whipple procedure (n = 4), hepaticojejunostomy (n = 9) and partial gastrectomy (n = 1). Indications for SBE-ERCP were obstructive jaundice (n = 10), cholangitis (n = 7), post-PTC internalization (n = 3) and biliary stent extraction/exchange (n = 2). The hepaticojejunostomy site (HJS) was reached in 15 (68 %) procedures. Successful interventions were performed in 11 (73 %) of 15 cases, including balloon dilation of biliary strictures (n = 3), insertion of biliary stents (n = 7), retrieval of biliopancreatic stents (n = 4) and biliary stone extraction (n = 4). The mean procedural time for successful interventions was 97.6 min (range 73-147 min). No procedural complications occurred during the median follow-up of 501 days (range 22-1,242 days). CONCLUSION: SBE-ERCP is safe and carries an acceptable success rate in experienced hands.

Combined interventional radiology followed by endoscopic therapy as a single procedure for patients with failed initial endoscopic biliary access.

BACKGROUND: Percutaneous transhepatic cholangiography (PTC) assisted endoscopic retrograde cholangiopancreatography (ERCP) usually requires two separate sessions. There are no reports to support performing the procedures in a single session. AIM: The purpose of this study was to assess the feasibility and safety of the ERCP rendezvous technique via PTC in a single session for patients with initially failed endoscopic biliary intervention. METHOD: We conducted a retrospective cohort study in a high volume tertiary referral center. A single experienced endoscopist and two interventional radiologists performed all the procedures. Patient demographics and all the related clinical data from January 2009 to July 2011 were obtained from hospital records. Outcome measures were the overall success rates of completion of the combined PTC and ERCP sessions for biliary drainage. Procedure-related complications (bleeding, perforation, hemobilia, bile leak, pancreatitis or cholangitis) were also assessed. RESULT: Twenty-three patients (14 men) with a median age of 68 years (range 47-89 years) underwent 26 combined PTC-ERCP as a single procedure. PTC and ERCP were both performed within 6 h of failed ERCP in 19 cases (73 %) and the others within 72 h. A total of 91 % of patients had underlying gastrointestinal metastatic cancers, and a surgically altered pancreaticobiliary system was found in 26 % of patients. Percutaneous biliary access was obtained via PTC in all procedures and successful rendezvous therapy was performed in 23 cases (88 %), which include biliary stone removal with a balloon catheter (n = 7) and biliary prostheses (n = 19). The median procedure length for successful PTC-ERCP rendezvous was 60 min (range 14-147 min). With the mean follow-up of 202 days (range 8-833 days), three immediate procedural complications [asymptomatic pneumoperitoneum (n = 2) and post biliary sphincterotomy bleeding (n = 1)] and two delayed complications (a hemorrhagic shock from a damaged branch of hepatic artery and a biloma with secondary infection) occurred, and there was no procedure-associated mortality. CONCLUSION: This is the first report assessing the feasibility and safety of a combined procedure of ERCP and PTC in a single session. In experienced hands, the combined approach in a single session is appropriate in selected patients with an acceptable risk.