Endoscopic ultrasound-guided choledochoduodenostomy using single-step lumen-apposing metal stents for primary drainage of malignant distal biliary obstruction (SCORPION-p): a prospective pilot study.

BACKGROUND: This study aimed to assess the safety and feasibility of endoscopic ultrasound-guided choledochoduodenostomy (EUS-CDS) using a lumen-apposing metal stent (LAMS) as a primary drainage strategy in patients with distal malignant biliary obstruction (MBO). METHODS: A prospective, single-center, pilot study was conducted in patients with pathology-confirmed MBO without gastric outlet obstruction. The primary outcome was technical success. Secondary outcomes included clinical success, adverse events (AEs), and reinterventions. The study was registered in the Netherlands Trial Registry (registry number NL9757). RESULTS: 22 patients were enrolled (median age 69.5 years [interquartile range 64-75.3]). Technical success was achieved in 20/22 patients (91 %). AEs occurred in one patient, namely perforation following inadequate stent deployment (5 %), which was treated in the same procedure. Clinical success was achieved in 19/22 patients (86 %). Stent dysfunction was observed in 11/20 patients (55 %) after technically successful EUS-CDS: two patients were treated conservatively and nine patients underwent reintervention(s). One patient died within ≤ 30 days due to fulminant disease progression. CONCLUSIONS: The results confirmed the safety and feasibility of EUS-CDS using LAMS as a primary drainage strategy. The high incidence of stent dysfunction should be improved before EUS-CDS with LAMS can be seen as a valid alternative to endoscopic retrograde cholangiopancreatography.

Recurrent cholangitis in patients with a non-stenotic hepaticojejunostomy: incidence and risk factors.

BACKGROUND: Cholangitis is a well-known complication after hepaticojejunostomy (HJ), which is mainly caused by a stenotic anastomosis. However, the rate of cholangitis in patients with a non-stenotic (i.e. patent) HJ is unknown. We aimed to evaluate the incidence and risk factors of recurrent cholangitis in patients with a non-stenotic HJ. METHODS: This single-center retrospective cohort study included all consecutive patients who had undergone hepatobiliary or pancreatic (HPB) surgery requiring HJ (2015-2022). Primary outcome was recurrent non-stenotic cholangitis, risk factors for recurrent non-stenotic cholangitis were identified using logistic regression. RESULTS: Overall, 835 patients with a HJ were included of whom 31/698 (4.4%) patients developed recurrent cholangitis with a non-stenotic HJ during a median follow-up of 34 months (IQR 22-50) and 98/796 (12.3%) patients developed a symptomatic HJ stenosis. These 31 patients experienced 205 cholangitis episodes, median 7.0 (IQR 3.8-8.8) per patient, and 71/205 (34.6%) cholangitis episodes required hospitalization. Male sex (aOR 3.17 (95% CI: 1.34-7.49)) and benign disease (aOR 2.97, 95% CI 1.40-6.33) were identified as risk factors for recurrent cholangitis in non-stenotic HJ in both univariate and multivariable analysis. CONCLUSION: This study shows that 4% of patients developed recurrent cholangitis without an underlying HJ stenosis.

Long-term efficacy of metal versus plastic stents in inoperable perihilar cholangiocarcinoma; a multicenter retrospective propensity score matched comparison.

BACKGROUND: For palliative drainage of inoperable perihilar cholangiocarcinoma (pCCA) uncovered metal stents are preferred over plastic stents. However, there is a lack of data on re-interventions at the long-term. The aim is to evaluate the potential difference in the number of re-interventions in patients surviving at least 6 months. METHODS: Retrospective study including patients with pCCA who underwent plastic stent placement(s) or had metal stent(s) in situ for at least 6 months. The primary outcome was the number of re-interventions per patient-year. A propensity score matching (1:1) analysis was performed using age, Bismuth classification, reason for inoperability, pathological confirmation, systemic therapy and initial approach (endoscopic vs percutaneous). RESULTS: Patients in the metal stent group (n = 87) underwent fewer re-interventions compared with the plastic stent group (n = 40) (3.0 vs. 4.7 per patient-year; IRR, 0.64; 95% CI, 0.47 to 0.88). When only non-elective re-interventions were included, there was no significant difference (2.1 vs. 2.7; IRR, 0.76; 95% CI, 0.55 to 1.08). Results were similar in the propensity score-matched dataset. CONCLUSIONS: This study shows that, also in patients with inoperable pCCA who survive at least 6 months, placement of metal stent(s) leads to fewer re-interventions in comparison with plastic stents.

Outcomes of thermal ablation of the defect margin after duodenal endoscopic mucosal resection (with videos).

BACKGROUND AND AIMS: Laterally spreading lesions (LSLs) in the duodenum are conventionally treated by EMR. Recurrence is commonly encountered and can be difficult to treat safely due to the unique anatomic characteristics of the duodenum. Auxiliary techniques designed to prevent recurrence have not been described. METHODS: We sought to evaluate the effectiveness of thermal ablation of the defect margin after EMR (EMR-T) in reducing recurrence at first surveillance endoscopy (SE1, scheduled at 6 months) in a single tertiary referral center. All duodenal LSLs ≥10 mm referred for EMR were eligible. After successful EMR, thermal ablation was performed using snare-tip soft coagulation around the entire circumference of the resection defect. The primary outcome was the frequency of recurrence at SE1. A previous, well-characterized, prospective cohort of duodenal LSLs ≥10 mm treated by conventional EMR was the comparator. RESULTS: Over 43 months up to October 2019, 54 LSLs underwent EMR-T. One hundred twenty-five LSLs underwent conventional EMR in the comparator group. Patient and lesion characteristics were similar between the groups. Recurrence was significantly lower in the EMR-T group compared with the conventional EMR group (1 of 49 [2.3%] vs 19 of 108 [17.6%]; P = .01). No difference in technical success, EMR-related adverse outcomes, or referral to surgery were identified between the groups. CONCLUSIONS: EMR-T significantly reduces the frequency of recurrence for duodenal LSLs. This technique is safe in the duodenum and has the potential to significantly improve the effectiveness of duodenal EMR. (Clinical trial registration number: NCT02306603.).

Expert consensus on endoscopic papillectomy using a Delphi process.

BACKGROUND AND AIMS: Consensus regarding an optimal algorithm for endoscopic treatment of papillary adenomas has not been established. We aimed to assess the existing degree of consensus among international experts and develop further concordance by means of a Delphi process. METHODS: Fifty-two international experts in the field of endoscopic papillectomy were invited to participate. Data were collected between August and December 2019 using an online survey platform. Three rounds were conducted. Consensus was defined as ≥70% agreement. RESULTS: Sixteen experts (31%) completed the full process, and consensus was achieved on 47 of the final 79 statements (59%). Diagnostic workup should include at least an upper endoscopy using a duodenoscope (100%) and biopsy sampling (94%). There should be selected use of additional abdominal imaging (75%-81%). Patients with (suspected) papillary malignancy or over 1 cm intraductal extension should be referred for surgical resection (76%). To prevent pancreatitis, rectal nonsteroidal anti-inflammatory drugs should be administered before resection (82%) and a pancreatic stent should be placed (100%). A biliary stent is indicated in case of ongoing bleeding from the papillary region (76%) or concerns for a (micro)perforation after resection (88%). Follow-up should be started 3 to 6 months after initial papillectomy and repeated every 6 to 12 months for at least 5 years (75%). CONCLUSIONS: This is the first step in developing an international consensus-based algorithm for endoscopic management of papillary adenomas. Surprisingly, in many areas consensus could not be achieved. These aspects should be the focus of future studies.

Clinical outcome of endoscopic treatment for symptomatic sterile walled-off necrosis.

BACKGROUND: The majority of patients with symptomatic sterile walled-off necrosis (WON) can be treated conservatively. Although endoscopic transluminal drainage (ETD) is often performed in cases of persistent symptoms, post-procedural iatrogenic infection may occur. This study aimed to evaluate clinical outcomes after ETD of symptomatic sterile WON. METHODS: This was a retrospective, multicenter, open-label case series of 56 patients with necrotizing pancreatitis who underwent ETD for symptomatic sterile WON between July 2001 and August 2018 at two tertiary referral hospitals. Primary end point was clinically relevant post-procedural iatrogenic infection, defined as need for endoscopic transluminal necrosectomy. Secondary end points included mortality, total number of interventions, hospital stay, and resolution of symptoms at 1-year follow-up.  RESULTS : ETD of sterile WON was performed in 56 patients (median age 55 years, 57 % male), who presented with abdominal pain (71 %), gastric outlet obstruction (45 %), jaundice (20 %), and failure to thrive (27 %). A total of 41 patients (73 %) developed clinically relevant post-procedural iatrogenic infection, resulting in a median of 3 (interquartile range [IQR] 2 - 4) endoscopic, radiological, and/or surgical interventions. Mortality rate was 2 %. Median total hospital stay was 12 days (IQR 6 - 17). Resolution of symptoms was reported in 40 of 46 patients (87 %) for whom long-term follow-up data were available (median follow-up 13 months, IQR 6 - 29). CONCLUSIONS: ETD of symptomatic sterile WON resulted in high clinical success. Nonetheless, the majority of patients required additional reinterventions for clinically relevant post-procedural iatrogenic infection.

Endoscopic papillectomy; a retrospective international multicenter cohort study with long-term follow-up.

BACKGROUND: Endoscopic papillectomy (EP) is considered a relatively safe and minimally invasive treatment for papillary adenomas. In the literature a significant risk for local recurrence is described. The aim of this study was to evaluate long-term recurrence rates and time-to-recurrence. Additionally, risk factors for recurrence, malignancy and adverse events were studied. METHODS: This is a retrospective study in consecutive patients with papillary adenomas who underwent EP in two tertiary referral hospitals between 2001 and 2018. Primary outcome was recurrence in patients with at least 1-year endoscopic follow-up. Secondary outcomes were surgery free survival, adverse events, and mortality within 30 days after the index procedure. RESULTS: A total of 259 patients were found eligible [median age 66 years, 130 male (50.2%)]. Forty-three patients were known with familial adenomatous polyposis (FAP) (16.6%). At least 1-year endoscopic follow-up was available in 154 patients with a total follow-up of 586 person-years and median of 40 months [interquartile range (IQR) 25-75]. Recurrence occurred in 24 cases (15.6%) of which 8 were known with FAP, leading to a recurrence incidence rate of 4.1 per 100 person-years with a median time-to-recurrence of 29 months (IQR 14.75-59.5). Fifty-three patients underwent at least 5-year follow-up, in 6 (11.3%) of them recurrence was encountered after 5 years of which four were known with FAP. No risk factors for recurrence could be identified. Adverse events occurred in 50/259 patients (19.3%). One patient died within 30 days after the procedure. Papillary stenosis occurred in 19/259 (7.3%) of the patients. There were no cases of malignant degeneration during follow-up. CONCLUSIONS: Recurrence after EP occurs in a significant proportion of patients and occurs even 5 years after EP. This emphasizes the need for long-term follow-up. We advise to consider at least 5-year follow-up in case of a sporadic adenoma, unless comorbidity makes follow-up clinically irrelevant.

Comparison of Intraductal RFA Plus Stent versus Stent-Only Treatment for Unresectable Perihilar Cholangiocarcinoma-A Systematic Review and Meta-Analysis.

BACKGROUND: One of the cornerstones of palliative treatment for unresectable perihilar cholangiocarcinoma is biliary stent placement in order to restore biliary drainage. In this review, the potential added value of RFA with stent placement in comparison to stent placement alone in patients with unresectable perihilar cholangiocarcinoma is analyzed. METHODS: We performed a comprehensive online search for relevant articles in November 2021 (PROSPERO ID: CRD42021288180). The primary endpoint was difference in overall survival. Secondary endpoints included overall survival, stent patency and complications. Only studies comparing survival after RFA + stent placement with stent placement alone were included in the meta-analysis. Non-comparative studies or comparative studies describing stent patency only were included in the systematic review. RESULTS: A total of nine studies, including 217 patients with pCCA who underwent RFA + stent placement and 294 patients who underwent stent-only treatment, met the inclusion criteria for the primary endpoint analysis. Direct comparison between the two treatment groups showed a significantly longer overall survival for RFA + stent treatment, with a pooled HR of 0.65 [95% CI, 0.50-0.84, I2 = 38%]. When all eligible studies were included, RFA + stent treatment revealed an overall survival of 9.5 months [95% CI, 6.3-12.6], whereas survival for stent-only treatment was 7.0 months [95% CI, 5.7-8.2]. Due to the heterogeneity of the data, no pooled data analysis could be performed on stent patency or complications. CONCLUSIONS: RFA + stent placement displays promising potential to prolong survival. However, further research incorporating confounding factors like use of palliative chemotherapy is necessary in order to validate these findings.