Vade Mecum in ERCP, a roadmap to success: Tips from experts for excelling in ERCP.

Background and study aims Training in endoscopic retrograde cholangiopancreatography (ERCP) is operator-dependent and traditionally, the apprenticeship model, in which experts are considered to be role models, has been adopted for it. The aim of this study was to develop a practical guide compiling tips from experts to help guide trainees to succeed in ERCP. Methods A web-based survey was created to understand the professional development of ERCP experts, the investments they made, the obstacles they overcame, and the quotes that guided their professional life. ERCP experts worldwide were invited to participate. Results Fifty-three experts (of 71; 74.6%) from 24 countries answered the survey. Experts started ERCP training early (average age 31 years; range, 24-52 years) and it often was combined with training for endoscopic ultrasound. A long training period (average 21 months; range, 3-120 months) was needed to achieve competence, frequently in another department, and it was commonly complemented with research in the field (76.5%). "Time and practice" were the most worthwhile investments they made to achieve success. "Sports" were an area outside endoscopy frequently considered to be important to acquire the skills necessary to excel in ERCP. "Lack of dedicated time for training" and "peer competition" were the biggest obstacles the experts faced. Several pieces of advice were given to the experts, such as to be resilient, careful, patient, responsible, and hard-working. "Personal life" was mentioned as an undeniably crucial factor for achieving long-term success that should not be forgotten. Conclusions This survey is the first to provide insight regarding the professional trajectory of renowned ERCP experts worldwide, providing valuable recommendations to help trainees excel in ERCP.

Safety and efficacy of salvage endoscopic submucosal dissection for Barrett's neoplasia recurrence after radiofrequency ablation.

BACKGROUND AND STUDY AIMS: This study evaluated the safety and efficacy of salvage endoscopic submucosal dissection for Barrett's neoplasia recurrence after radiofrequency ablation. PATIENTS AND METHODS: Data from patients at sixteen centers were collected for a multicentric retrospective study. Patients who underwent at least one RFA treatment for Barrett's esophagus and thereafter underwent further esophageal ESD for neoplasia recurrence were included. RESULTS: Data from 56 patients treated by salvage ESD performed between April 2014 and November 2022 were collected. Immediate complications included one muscular tear (1.8%) treated with stent (Agree classification: grade IIIa), two patients had transmural perforations (4%) and five patients had muscular tears (9%) treated with clips and without clinical impact and not considered as adverse event. Seven patients (12.5%) developed strictures, treated by balloon dilation (grade IIIa). Histological analysis showed 36 adenocarcinomas, 17 high-grade dysplasia, and 3 low-grade dysplasia. En-bloc and R0 resection rates were 89% and 66%, respectively. Resections were curative in thirty-three patients (59%), non-curative in 22 patients (39%), including 11 "local risk" (19.5%) and 11 "high risk" resections (19.5%). At the end of follow-up with a median time of 14 [0-75] months after salvage ESD eventually associated with further endoscopic treatment (RFA, argon plasma coagulation, endoscopic mucosal resection, ESD), neoplasia remission ratio was 37/53 (70%) and the median remission time was 13 [1-75] months. CONCLUSION: In expert hands, salvage ESD is a safe and effective treatment for recurrence of Barrett's neoplasia after RFA treatment.

Digestive neo-epithelialization after endoscopic stenting for upper digestive tract complete disunion.

BACKGROUND: Complete digestive disunion due to anastomotic necrosis is considered a contraindication to endoscopic repair. However, recent publications have suggested that endoscopic treatment by insertion of a self-expandable metal stent (SEMS) is possible. The report of this patient series aims to demonstrate the use of endoscopic management in selected cases with complete digestive disunion. METHODS: Seven consecutive patients with complete and circumferential upper gastrointestinal anastomotic disunion were treated at two European tertiary care centers between 2009 and 2021 by endoscopic insertion of an SEMS. Treatment was performed with a therapeutic gastroscope under general anesthesia, carbon dioxide insufflation, and fluoroscopic guidance, after surgical or percutaneous drainage. RESULTS: All patients were successfully treated by endoscopic insertion of fully or partially covered SEMS left in place for a median of 8 weeks, with a median of 3 endoscopic sessions. Digestive neo-epithelialization was associated with a restored circumferential gut lumen in all cases. The rate of stent migration was 23% and three patients (43%) experienced symptomatic strictures, which were successfully treated by endoscopic dilation. CONCLUSION: Complete digestive rupture could be successfully treated by endoscopy in selected cases, adding proof-of-concept data regarding guided tissue regeneration alongside SEMS placement.

Intravenous Hemin, a potential heme oxygenase-1 activator, does not protect from post-ERCP acute pancreatitis in humans: Results of a randomized multicentric multinational placebo-controlled trial.

OBJECTIVE: Hemin, a heme oxygenase 1 activator has shown efficacy in the prevention and treatment of acute pancreatitis in mouse models. We conducted a randomized controlled trial (RCT) to assess the protective effect of Hemin administration to prevent post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) in patients at risk. METHODS: In this multicenter, multinational, placebo-controlled, double-blind RCT, we assigned patients at risk for PEP to receive a single intravenous dose of Hemin (4 mg/kg) or placebo immediately after ERCP. Patients were considered to be at risk on the basis of validated patient- and/or procedure-related risk factors. Neither rectal NSAIDs nor pancreatic stent insertion were allowed in randomized patients. The primary outcome was the incidence of PEP. Secondary outcomes included lipase elevation, mortality, safety, and length of stay. RESULTS: A total of 282 of the 294 randomized patients had complete follow-up. Groups were similar in terms of clinical, laboratory, and technical risk factors for PEP. PEP occurred in 16 of 142 patients (11.3%) in the Hemin group and in 20 of 140 patients (14.3%) in the placebo group (p = 0.48). Incidence of severe PEP reached 0.7% and 4.3% in the Hemin and placebo groups, respectively (p = 0.07). Significant lipase elevation after ERCP did not differ between groups. Length of hospital stay, mortality and severe adverse events rates were similar between groups. CONCLUSION: We failed to detect large improvements in PEP rate among participants at risk for PEP who received IV hemin immediately after the procedure compared to placebo. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov number, NCT01855841).

Assessing the impact of center volume on the cost-effectiveness of centralizing ERCP.

BACKGROUND AND AIMS: ERCP is a complex endoscopic procedure in which the center's procedure volume influences outcomes. With the increasing healthcare expenses and limited resources, promoting cost-effective care becomes essential for healthcare provision. This study performed a cost-effectiveness analysis to evaluate the hypothesis that high-volume (HV) centers perform ERCP with higher quality at lower costs than low-volume (LV) centers. METHODS: A baseline case compared the current distribution of ERCPs among HV and LV centers with a hypothetical scenario in which all ERCPs are performed at HV centers. A cost-effectiveness analysis was constructed, followed by one-way and two-way sensitivity analyses and probabilistic sensitivity analysis (PSA) using Monte Carlo simulations. RESULTS: In the baseline case, the ICER was -141,017€/year, due to the hypothetical scenario's lower costs and slightly higher QALYs. The model was most sensitive to changes in the transportation costs (109.34%), probability of significant adverse events (AEs) after successful ERCP at LV centers (42.12%), utility after ERCP with significant AEs (30.10%), and probability of significant AEs after successful ERCP at HV centers (23.53%) but only transportation cost above 3,407€ changed the study outcome. The current ERCP distribution would only be cost-effective if LV centers achieved higher success (≥ 92.4% vs. 89.3%) with much lower significant AEs (≤ 0.5% vs 6.7%). The study's main findings remained unchanged while combining all model parameters in the PSA. CONCLUSIONS: Our findings show that HV centers have high-performance rates at lower costs, raising the need to consider the principle of centralization of ERCPs into HV centers to improve the quality of care.

Strong Sustainability of Medical Technologies: A Medical Taboo? The Case of Disposable Endoscopes.

This paper aims to question the sustainability of biomedical engineering practices. The strong sustainability framework is applied to the evaluation and development of medical technologies through the definition of clinical sustainability. A roadmap for developing and evaluating medical technologies in this respect is derived from this framework, as a first step toward a multidisciplinary evaluation tool. On this basis, the current trend towards disposable endoscopes is analyzed and discussed. This highlights the subtle balance between economic, clinical, social, and environmental factors, the lack of evidence at these multiple levels, and the need for multidisciplinarity. This paper concludes with the need to assess all aspects of sustainability and identify and quantify the trade-offs, instead of focusing on one or two key indicators, to have more relevant information in order to make better and more effective decisions. Towards sustainable healthcare, we outline two paths of action: (1) providing evidence that is lacking on the environmental impact of existing or currently developed medical technologies and (2) clarifying the premises and visions underlying our practices.Clinical Relevance- This work provides insights regarding the strong sustainability of medical technologies. This clinical framework may help clinicians and developers in decision-making to reduce indirect negative ecological, social, and health impacts.

Pilot study of an endoluminal-suturing device as a treatment for patients with gastroesophageal reflux disease.

Background and study aims Endoscopic therapy is a promising option for patients with gastroesophageal reflux disease (GERD). The aim of this study was to assess safety and feasibility of the Endomina suturing platform as a treatment for GERD. Patients and methods This was a two-center study of patients with chronic GERD symptoms that responded at least partially to proton pump inhibitors (PPIs). Primary endpoints were to assess the safety of the procedure and persistence of the sutures. Secondary endpoints were to assess esophageal pH-impedance and manometry parameters changes at 6 months, as well as GERD symptoms and PPI use up to 12 months of follow-up. Results Fourteen patients were treated (13 males, mean of 43±12 years), with a mean number of three plications per patient. Thirteen, 10, and nine patients were analyzed at 3, 6, and 12 months of follow-up, respectively. One device-related adverse event occurred (loss of needle tip requiring endoscopic retrieval 1 week later). A mean of two plications persisted at 3 and 12 months. A decrease in median acid exposure time and reflux episodes was observed after the procedure. Mean Reflux Symptom Index and GERD-Health-Related Quality of Life scores decreased during follow-up visits and 90% of the patients discontinued PPI use at 1 year. Conclusions Endoscopic full-thickness suturing of the esophagogastric junction with the Endomina suturing platform is feasible, allowing persistence of two-thirds of the plications, with promising results for decreasing reflux and improving GERD symptoms.

Mediastinal Abscess Formation after EUS-Guided Sampling in a Young Patient with Sarcoidosis: Be Aware of the Increased Risk!

International guidelines establish EUS-guided sampling as safe and accurate for the evaluation of mediastinal solid lesions, such as lymphadenopathies of unknown origin, and point out an increased risk of severe infectious complications induced by needle puncture in mediastinal cystic lesions. A retrospective case series and a systematic review documented an increased risk of mediastinal abscess formation after EUS-guided lymph nodes sampling in patients with sarcoidosis. The authors describe a case of a 38-year-old male patient with a final diagnosis of sarcoidosis, who developed a large mediastinal abscess after EUS-guided fine-needle biopsy of mediastinal lymphadenopathies. Endoscopists should be aware of the potential increased risk of severe infectious complications when sampling mediastinal lymph nodes in suspected sarcoidosis, and a strategy to minimize such risk should be pursued.

As normas de consenso internacionais estabelecem a biopsia guiada por ecoendoscopia como segura e precisa no diagnóstico de lesões sólidas do mediastino, tais como adenopatias de origem indeterminada, e sublinham o risco significativo de complicações infecciosas graves associado à punção de lesões mediastínicas quísticas. Uma série retrospectiva e uma revisão sistemática apontaram para um risco aumentado de abcesso mediastínico após punção guiada por ecoendoscopia de gânglios linfáticos em doentes com sarcoidose. Os autores descrevem o caso cínico de um jovem de 38 anos, com o diagnóstico final de sarcoidose, que desenvolveu um volumoso abcesso mediastínico após biopsia guiada por ecoendoscopia de adenopatias mediastínicas. Os endoscopistas deverão reconhecer o risco aumentado de complicações infeciosas graves aquando da punção de adenopatias mediastínicas na suspeita de sarcoidose e procurar definir uma estratégia preventiva para minimizar o referido risco.

The impact of a multidisciplinary team approach on the management of focal pancreatic lesions: a single tertiary center experience.

Background: Multidisciplinary team (MDT) meetings aim to optimize patient management. We evaluated the impact of MDT discussions on the management and diagnosis of focal pancreatic lesions in a single tertiary center. Methods: All patients with an initial diagnosis of solid or cystic pancreatic lesion discussed in our institution's MDT meeting on pancreatic diseases between January 1, 2020, and December 31, 2021, were included. The impact of MDT discussion on patient management, defined as a modification of the initially proposed therapeutic plan after MDT discussion, as well as the criteria leading to this modification, were the primary outcomes. Impact on diagnosis was the secondary outcome. Results: A total of 522 patients were included. Of these, 185 (35.4%) and 337 (64.6%) had an initial diagnosis of cystic or solid lesion, respectively. The most common referral query was regarding the management plan (349/522; 66.9%). Endoscopy was the procedure most often proposed before MDT discussion (109/522; 20.9%). Overall, the MDT discussion led to modification of the management plan in 377/522 patients (72.2%), with a statistically significant difference between cystic and solid lesions (63.2% vs. 77.2%; P<0.001). Management modifications were mainly driven by revision of cross-sectional radiological images. MDT discussion led to modification of the diagnosis in 92/522 patients (17.6%), with a significant difference regarding cystic lesions (35.7% vs. 7.7%; P<0.001). Conclusion: MDT discussion impacts the management of patients with cystic and solid pancreatic lesions, leading to a modification of the initially proposed management in two-thirds of them, mainly through revision of cross-sectional imaging.

Endoscopic Ultrasound-Guided Pancreatic Duct Interventions.

Endoscopic ultrasound (EUS)-guided pancreatic duct drainage is one of the most challenging procedures in therapeutic endoscopy. Technical success is lower than for other therapeutic EUS procedures. However, when successful in a clear clinical indication, this procedure can offer a useful therapeutic alternative and improves the overall clinical success of the endoscopic approach. Current challenges include the standardization of clinical indications and of the techniques used for accessing the pancreatic duct, the strategy for mid-term and long-term management, and definition of the scope of the training that should be offered to a few highly experienced endoscopists.

Candy cane syndrome: A systematic review.

BACKGROUND: Candy cane syndrome (CCS) is a condition that occurs following gastrectomy or gastric bypass. CCS remains underrecognized, yet its prevalence is likely to rise due to the obesity epidemic and increased use of bariatric surgery. No previous literature review on this subject has been published. AIM: To collate the current knowledge on CCS. METHODS: A literature search was conducted with PubMed and Google Scholar for studies from May 2007, until March 2023. The bibliographies of the retrieved articles were manually searched for additional relevant articles. RESULTS: Twenty-one articles were identified (135 patients). Abdominal pain, nausea/vomiting, and reflux were the most reported symptoms. Upper gastrointestinal (GI) series and endoscopy were performed for diagnosis. Surgical resection of the blind limb was performed in 13 studies with resolution of symptoms in 73%-100%. In surgical series, 9 complications were reported with no mortality. One study reported the surgical construction of a jejunal pouch with clinical success. Six studies described endoscopic approaches with 100% clinical success and no complications. In one case report, endoscopic dilation did not improve the patient's symptoms. CONCLUSION: CCS remains underrecognized due to lack of knowledge about this condition. The growth of the obesity epidemic worldwide and the increase in bariatric surgery are likely to increase its prevalence. CCS can be prevented if an elongated blind loop is avoided or if a jejunal pouch is constructed after total gastrectomy. Diagnosis should be based on symptoms, endoscopy, and upper GI series. Blind loop resection is curative but complex and associated with significant complications. Endoscopic management using different approaches to divert flow is effective and should be further explored.

A machine learning-based classification of adult-onset diabetes identifies patients at risk of liver-related complications.

Background & aims: Diabetes mellitus is a major risk factor for fatty liver disease development and progression. A novel machine learning method identified five clusters of patients with diabetes, with different characteristics and risk of diabetic complications using six clinical and biological variables. We evaluated whether this new classification could identify individuals with an increased risk of liver-related complications. Methods: We used a prospective cohort of patients with a diagnosis of type 1 or type 2 diabetes without evidence of advanced fibrosis at baseline recruited between 2000 and 2020. We assessed the risk of each diabetic cluster of developing liver-related complications (i.e. ascites, encephalopathy, variceal haemorrhage, hepatocellular carcinoma), using competing risk analyses. Results: We included 1,068 patients, of whom 162 (15.2%) were determined to be in the severe autoimmune diabetes subgroup, 266 (24.9%) had severe insulin-deficient diabetes, 95 (8.9%) had severe insulin-resistant diabetes (SIRD), 359 (33.6%) had mild obesity-related diabetes, and 186 (17.4%) were in the mild age-related diabetes subgroup. In multivariable analysis, patients in the SIRD cluster and those with excessive alcohol consumption at baseline had the highest risk for liver-related events. The SIRD cluster, excessive alcohol consumption, and hypertension were independently associated with clinically significant fibrosis, evaluated by liver biopsy or transient elastography. Using a simplified classification, patients assigned to the severe and mild insulin-resistant groups had a three- and twofold greater risk, respectively, of developing significant fibrosis compared with those in the insulin-deficient group. Conclusions: A novel clustering classification adequately stratifies the risk of liver-related events in a population with diabetes. Our results also underline the impact of the severity of insulin resistance and alcohol consumption as key prognostic risk factors for liver-related complications. Impact and implications: Diabetes represents a major risk factor for NAFLD development and progression. This study examined the ability of a novel machine-learning approach to identify at-risk diabetes subtypes for liver-related complications. Our results suggest that patients that had severe insulin resistance had the highest risk of liver-related outcomes and fibrosis progression. Moreover, excessive alcohol consumption at the diagnosis of diabetes was the strongest risk factor for developing liver-related events.

Face and content validity of a biological papilla designed for the Boskoski-Costamagna ERCP simulator.

BACKGROUND AND AIMS: A biological papilla made of chicken heart tissue, incorporated into the Boskoski-Costamagna ERCP Trainer simulator, was recently designed to allow training in sphincterotomy. This study aimed to evaluate the face and content validity of this tool. METHOD: Participants from 2 groups (nonexperienced and experienced [<600 or >600 lifetime ERCPs, respectively]) were invited to perform standardized assignments on the model: sphincterotomy and precut for both groups and papillectomy for the experienced group. Following these assignments, all participants filled out a questionnaire to rate their appreciation of the realism of the model, and experienced endoscopists were also asked to evaluate its didactic value using a 5-point Likert scale. RESULTS: A total of 19 participants were included (nonexperienced, n = 10; experienced, n = 9). Parameters regarding the realism of the tool in terms of general appearance, sphincterotomy, precut, and papillectomy were overall considered realistic (4 of 5), with good agreement rates in terms of overall realism between groups. Experienced operators reported the highest realism for "positioning the scope and needle-knife in the field of view" and "during precut," "cutting in small increments during precut," and "controlling the scope during papillectomy," and they highly agreed that this papilla should be included for training novice and intermediate trainees in sphincterotomy, precut, and papillectomy. CONCLUSIONS: Our results show good face validity and excellent content validity of this biological papilla combined with the Boskoski-Costamagna ERCP Trainer. This new tool provides a useful, inexpensive, versatile, and easy tool for training regarding sphincterotomy, precut, and papillectomy. Future studies should explore whether including this model in real-life training improves the learning curve of endoscopy trainees.

Impact of center and endoscopist ERCP volume on ERCP outcomes: a systematic review and meta-analysis.

BACKGROUND AND AIMS: Endoscopist experience and center volume might be associated with ERCP outcomes, as in other fields of endoscopy and in surgery. An effort to assess this relationship is important to improve practice. This systematic review and meta-analysis aimed to evaluate these comparative data and to assess the impact of endoscopist and center volume on ERCP procedure outcomes. METHODS: We performed a literature search in PubMed, Web of Science, and Scopus through March 2022. Volume classification included high- and low-volume (HV and LV) endoscopists and centers. The primary outcome was the impact of endoscopist and center volume on ERCP success. Secondary outcomes were the overall adverse event (AE) rate and the specific AE rate. The quality of the studies was assessed using the Newcastle-Ottawa scale. Data synthesis was obtained by direct meta-analyses using a random-effects model; results are presented as odds ratios (ORs) with 95% confidence intervals (CIs). RESULTS: Of 6833 relevant publications, 31 studies met the inclusion criteria. Procedure success was higher among HV endoscopists (OR, 1.81; 95% CI, 1.59-2.06; I2 = 57%) and in HV centers (OR, 1.77; 95% CI, 1.22-2.57; I2 = 67%). The overall AE rate was lower for procedures performed by HV endoscopists (OR, .71; 95% CI, .61-.82; I2 = 38%) and in HV centers (OR, .70; 95% CI, .51-.97; I2 = 92%). Bleeding was less frequent in procedures performed by HV endoscopists (OR, .67; 95% CI, .48-.95; I2 = 37%) but did not differ based on center volume (OR, .68; 95% CI, .24-1.90; I2 = 89%). No statistical differences were detected concerning pancreatitis, cholangitis, and perforation rates. CONCLUSIONS: HV endoscopists and centers provide higher ERCP success rates with fewer overall AEs, especially bleeding, compared with respective LV comparators.

A portrait of Endoscopic retrograde cholangiopancreatography and endoscopic ultrasound training programs in Europe: Current practices and opportunities for improvement.

BACKGROUND: Endoscopic retrograde cholangiopancreatography (ERCP) and EUS are challenging procedures requiring a high level of expertise to provide effective and safe patient care. Thus, high-quality training is needed to achieve competence. We aimed to evaluate the status of European ERCP/EUS training programs, to evaluate adherence to international recommendations, and to propose possible solutions for future improvements. METHODS: A web-based survey was developed and ERCP/EUS experts and trainees across Europe were invited to participate. RESULTS: Forty-one experts (out of 50; 82%) and 30 trainees (out of 70; 42.9%) from 18 countries answered the questionnaire. The training program application process is mainly driven by individual requests (87.8%). All surveyed departments offer combined ERCP/EUS training and the majority have adequate facilities and trainers. Although centers are high-volume and provide long-term fellowships, trainee hands-on exposure is not very high (43% expect to do (or did) 100-150 ERCPs and 69% up to 150 EUSs). A formal curriculum is in place in 53.7% centers, including simulation-training in 27.3%. Competence is assessed in 65.7% of centers, but validated tools are applied in only 33.3%. CONCLUSIONS: This survey first provides an overview of ERCP/EUS training programs across Europe. It shows that there is adherence to international guidelines to a certain degree, but several gaps in the application process, use of simulators for training, training curriculum and assessment of performance have been recognized. Overcoming these shortcomings could serve as a basis for further improvement in ERCP/EUS training.

Who will excel in advanced endoscopy? A study assessing the criteria and perceptions of experts with regard to selection of ERCP and EUS trainees.

Background and study aims Training program directors (TPDs) and experts play a crucial role in selecting ERCP/EUS trainees and determining the workforce in endoscopy. Additionally, prospective trainees should know what TPDs/experts expect from them. Nonetheless, the criteria and perceptions used in this selection have not been clarified. The aim of this study was to identify TPD/expert values/beliefs regarding personal attributes needed for selecting trainees that can excel and those which may lead to disqualification; compare perspectives between TPDs/experts and trainees regarding the selection process and critical trainee characteristics; and investigate the general approach and satisfaction regarding current application process for ERCP/EUS training. Methods We conducted a web-based survey to collect general opinion and data regarding the application process and trainee selection and disqualification from training. European TPDs/experts and trainees were invited to participate. Results Thirty-six TPDs/experts and 25 trainees from 18 countries responded. The application process is mainly driven by individual request (86.1 %). Almost half of TPDs/experts felt only moderately (38.9 %) to slightly (8.3 %) satisfied with the current application process. TPDs/experts value a diversity of trainee characteristics, but mainly traits such as "honesty," "being a team player," and "self-awareness" (72.2 % each). Technical skills ranked seventh as considered "extremely important." "Disregard for patient welfare" and "lack of work ethic" were the most common reasons for disqualification. TPDs/experts and trainees agreed in most questions. Conclusions This survey outlines trainee selection criteria for ERCP/EUS training. Non-technical skills are the most valued by TPDs/experts. While knowledge and technical expertise are clearly important, understanding that professional attitudes are highly regarded may help direct the application process more effectively.

Portal cavernography during endoscopic retrograde cholangiopancreatography: from bilhemia to hemobilia.

Portobiliary fistulas are rare but may lead to life-threatening complications. Biliary plastic stent-induced portobiliary fistulas during endoscopic retrograde cholangiopancreatography have been described. Herein, we present a case of portal cavernography and recurrent hemobilia after endoscopic retrograde cholangiopancreatography in which a portobiliary fistula was detected in a patient with portal biliopathy. This likely indicates a change in clinical presentation (from bilhemia to hemobilia) after biliary drainage that was successfully treated by placement of a fully covered, self-expandable metallic stent.

Endoscopic Treatment of Large Bile Duct Stones: A Systematic Review and Network Meta-Analysis.

BACKGROUND & AIMS: Several endoscopic methods have been proposed for the treatment of large biliary stones. We assessed the comparative efficacy of these treatments through a network meta-analysis. METHODS: Nineteen randomized controlled trials (2752 patients) comparing different treatments for management of large bile stones (>10 mm) (endoscopic sphincterotomy, balloon sphincteroplasty, sphincterotomy followed by endoscopic papillary large balloon dilation [S+EPLBD], mechanical lithotripsy, single-operator cholangioscopy [SOC]) with each other were identified. Study outcomes were the success rate of stone removal and the incidence of adverse events. We performed pairwise and network meta-analysis for all treatments, and used Grading of Recommendations, Assessment, Development, and Evaluation criteria to appraise the quality of evidence. RESULTS: All treatments except mechanical lithotripsy significantly outperformed sphincterotomy in terms of stone removal rate (risk ratio [RR], 1.03-1.29). SOC was superior to other adjunctive interventions (vs balloon sphincteroplasty [RR, 1.24; 95% CIs, 1.07-1.45], vs S+EPLBD [RR, 1.23; range, 1.06-1.42] and vs mechanical lithotripsy [RR, 1.34; range, 1.14-1.58]). Cholangioscopy ranked the highest in increasing the success rate of stone removal (surface under the cumulative ranking [SUCRA] score, 0.99) followed by S+EPLBD (SUCRA score, 0.68). SOC and S+EPLBD outperformed the other modalities when only studies reporting on stones greater than 15 mm were taken into consideration (SUCRA scores, 0.97 and 0.71, respectively). None of the assessed interventions was significantly different in terms of adverse event rate compared with endoscopic sphincterotomy or with other treatments. Post-ERCP pancreatitis and bleeding were the most frequent adverse events. CONCLUSIONS: Among patients with large bile stones, cholangioscopy represents the most effective method, in particular in patients with larger (>15 mm) stones, whereas S+EPLBD could represent a less expensive and more widely available alternative.

Soft self-expandable metal stent to treat painful pancreatic duct strictures secondary to chronic pancreatitis: a prospective multicenter trial.

BACKGROUND AND AIMS: Fully covered self-expandable metal stents (FCSEMSs) may offer a treatment option for pain associated with a dilated pancreatic duct (PD) in chronic pancreatitis (CP), but optimal patient selection and FCSEMS design, efficacy, and safety remain uncertain. We studied an investigational pancreatic FCSEMS for treatment of CP-associated pain. METHODS: Patients with painful CP, a dominant distal PD stricture, and PD dilation upstream were enrolled in a prospective, multicenter, single-arm trial studying 6-month indwell of a 4- to 6-cm-long soft pancreatic FCSEMS. Primary efficacy and safety endpoints were pain reduction 6 months after FCSEMS indwell (performance goal ≥53%) and PD stenting-related serious adverse events (SAEs), respectively (performance goal <32%). The primary efficacy endpoint was assessed in patients with sufficiently severe and frequent pain at FCSEMS placement as a first stent or in exchange of a plastic stent. RESULTS: Among 67 patients (mean age, 52.7 ± 12.5 years; mean time since CP diagnosis, 6.4 ± 6.4 years), 34 (50.7%) had plastic stent placement within 90 days of FCSEMS placement, and 46 patients were eligible for the primary efficacy endpoint analysis. Technical success was 97.0% (65/67). The observed primary efficacy (26.1%, 12/46) and safety endpoints (31.3%, 21/67) failed to meet the a priori study hypotheses. Study stent migration occurred in 47.7% of patients (31/65). CONCLUSIONS: Six-month treatment with an FCSEMS did not lead to an expected degree of pain reduction, and migrations and SAEs were common. Further study is needed to clarify optimal decompressive strategy, FCSEMS design, and patient selection. (Clinical trial registration number: NCT02802020.).

Endoscopic Reconstruction of an Oral Feeding Route Using a Rendezvous Approach.

Background: The approach to esophageal obstruction or discontinuity remains challenging and often involves complex reconstructive surgeries. The rendezvous endoscopic technique might be interesting in cases of complete esophageal obstruction. Case Presentation: Herein we describe a successful case of endoscopic recanalization of the esophageal lumen in a patient with a long-standing esophageal discontinuity resulting from several surgeries and chemoradiation for a squamous cell carcinoma of the hypopharynx, ending in a major cervical amputation, construction of a neopharynx, and definitive surgical closure of the superior esophagus with a PEG placement. With a rendezvous technique (peroral and through the gastrostomy) and under radiographic guidance, puncture from the neopharynx into the distal esophagus was performed, followed by balloon dilation and covered metal stent placement in order to reconstruct a neoesophagus. Five weeks later, the stent was removed (using a stent-in-stent technique). No complications occurred. The patient has been able to eat soft food and is being kept under regular endoscopic surveillance to control/treat a luminal stenosis of the neoesophagus. Conclusions: This case report illustrates a successful endoscopic treatment of post-surgical complete esophageal obstruction. This approach should be considered in the therapeutic armamentarium of these difficult clinical settings.

Introdução: A abordagem da descontinuidade esofágica permanece desafiante e frequentemente envolve cirurgias reconstrutivas complexas. A técnica endoscópica de rendez-vous pode ser interessante em casos de obstrução esofágica completa. Apresentação do caso: Descrevemos um caso de sucesso de recanalização endoscópica do lúmen esofágico de um doente com descontinuidade esofágica de longa duração, em resultado de múltiplas cirurgias e quimioradiação por um carcinoma pavimento-celular da hipofaringe, que resultou numa amputação cervical major, construção de uma neofaringe e encerramento cirúrgico definitivo do esófago com colocação de PEG. Por técnica de rendez-vous (peroral e por gastrostomia) e sob apoio radiológico, foi realizada punção da neofaringe, seguido de dilatação com balão e colocação de prótese metálica coberta para criar um neo-esófago. Cinco semanas depois, a prótese foi removida (por técnica stent-in-stent). Não ocorreram complicações. O doente tem mantido capacidade de ingerir comida pastosa e é submetido a vigilância regular endoscópica para controlar/tratar uma estenose do lúmen do neo-esófago. Conclusão: Este caso ilustra o tratamento endoscópico bem-sucedido de um doente com obstrução pós-cirúrgica completa do esófago. Esta abordagem deverá ser considerada no arsenal terapêutico destes quadros clínicos complexos.