Clinical outcomes of the over-the-scope clip closure after duodenal endoscopic submucosal dissection: A multicenter retrospective study.

BACKGROUND AND AIM: Prophylactic closure with the over-the-scope clip (OTSC) after endoscopic submucosal dissection (ESD) of superficial non-ampullary duodenal epithelial tumors (SNADETs) has been reported to reduce postoperative adverse events (AEs). However, there are few evidences regarding AEs-associated factors and long-term outcomes of OTSCs. METHODS: From January 2011 to December 2020, 139 consecutive patients with SNADETs who underwent ESD followed by OTSC closure in five institutions were extracted in this retrospective study. The primary endpoint was the rate of postoperative AEs after prophylactic OTSC closure. The secondary endpoints were the complete closure rate, residual rate, and long-term AEs associated with residual OTSCs. RESULTS: The rate of complete closure of the mucosal defect was 97.3% (142) in 146 SNADETs, which were completely resected by ESD. Postoperative AEs, including delayed bleeding, delayed perforation, and localized peritonitis, occurred in 6.2%, 3.4%, and 2.1% of patients, respectively; however, all of the cases improved without surgical treatment. In the multivariate logistic regression analysis, the use of two or more OTSCs was a significant independent risk factor for postoperative AEs (odds ratio, 2.94; 95% confidence interval, 1.02-8.46; P = 0.046). The residual OTSC rate was 46.4% at 1 year postoperatively, and long-term AEs included duodenal erosions and ulcers associated with residual OTSCs. CONCLUSIONS: Prophylactic closure with OTSCs after duodenal ESD can provide acceptable short-and long-term outcomes for preventing postoperative AEs. However, multiple OTSCs were the independent risk factors of postoperative AEs due to the gaps between and near the OTSCs.

Endoscopic ultrasound­guided biliary drainage in patients with surgically altered anatomy: a systematic review and Meta­analysis.

BACKGROUND AND AIMS: Endoscopic retrograde cholangiopancreatography is technically challenging to perform in patients with surgically altered anatomy (SAA). For these patients, endoscopic ultrasound-guided biliary drainage (EUS-BD) is one of the good indications. The aim of our systematic review and meta-analysis was to identify and evaluate evidence of the efficacy and safety of EUS-BD in patients with SAA. METHODS: A systematic review of the PubMed was conducted through to December 2021 to identify studies performing EUS-BD in patients with SAA. The primary outcome was the pooled technical success proportion in patients with SAA. The pooled clinical success and adverse event proportions in patients with SAA were also analyzed. RESULTS: The search identified 1195 possible records, with 18 studies meeting our criteria for analysis, reporting data for 409 patients with SAA who underwent EUS-BD. The pooled technical success, clinical success and adverse event proportions in patients with SAA were 97.8% (95% confidence interval [CI], 95.8-99.7%), 94.9% (95% CI, 91.8-98.1%), and 12.8% (95% CI, 7.4-18.1%), respectively. CONCLUSIONS: EUS-BD is effective for patients with SAA. However, adverse events should be considered when performing EUS-BD in these patients.

Can endoscopic retrograde cholangiopancreatography-related procedures for resolving acute cholangitis be effectively and safely performed in patients with surgically altered anatomy? Comparison study to evaluate the timing of short-type single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography.

OBJECTIVES: Balloon enteroscopy (BE)-assisted endoscopic retrograde cholangiopancreatography (ERCP)-related procedures to resolve acute cholangitis (AC) in patients with surgically altered anatomy (SAA) are limited. There is a lack of evidence on whether the timing of BE-assisted ERCP affects clinical outcomes in patients with AC. This study aimed to evaluate the clinical outcomes of short-type single-balloon enteroscopy (short SBE)-assisted ERCP in patients with SAA and AC. METHODS: Patients with AC who underwent short SBE-assisted ERCP procedures between September 2011 and April 2022 were retrospectively reviewed. The outcomes of procedures undergone at ≤24 h and >24 h were compared. The primary outcome was the length of stay (LOS). RESULTS: Overall, 56 patients underwent procedures at ≤24 h, and 58 patients at >24 h. The procedural success and adverse event rates of short SBE-assisted ERCP were 87.7% (95% confidence interval [CI] 80.3-93.1%) and 4.4% (95% CI 1.4-9.9%), respectively. Patients with severe (Grade III) AC and systemic inflammatory response syndrome were more in early (at ≤24 h) ERCP groups. LOS and median time from ERCP procedures to discharge were shorter in the early group. Procedural success and adverse event rates between both groups had no significant differences. Multivariable linear regression analysis showed that ERCP performed at ≤24 h was associated with shorter LOS, while severe cholangitis and malignant biliary obstruction were associated with longer LOS. CONCLUSIONS: Short SBE-assisted ERCP is effective and safe in patients with SAA and AC. Early procedures seemed to attribute early improvement of general condition, thus shortening the LOS.

Clinical course and management of adverse events after endoscopic resection of superficial duodenal epithelial tumors: Multicenter retrospective study.

OBJECTIVES: This study aimed to elucidate the clinical course and management of adverse events (AEs) after endoscopic resection (ER) for superficial duodenal epithelial tumors (SDETs). METHODS: Consecutive patients who underwent ER of SDETs between January 2008 and July 2018 at 18 Japanese institutions were retrospectively enrolled. The study outcomes included the clinical course, management, and risk of surgical conversion with perioperative AEs after ER for SDETs. RESULTS: Of the 226 patients with AEs, the surgical conversion rate was 8.0% (18/226), including 3.7% (4/108), 1.0% (1/99), and 50.0% (12/24) of patients with intraoperative perforation, delayed bleeding, or delayed perforation, respectively. In the multivariate logistic analysis, involvement of the major papilla (odds ratio [OR] 12.788; 95% confidence interval [CI] 2.098-77.961, P = 0.006) and delayed perforation (OR 37.054; 95% CI 10.219-134.366, P < 0.001) were significant risk factors for surgical conversion after AEs. Delayed bleeding occurred from postoperative days 1-14 or more, whereas delayed perforation occurred within 3 days in all cases. CONCLUSIONS: The surgical conversion rate was higher for delayed perforation than those for other AEs after ER of SDETs. Involvement of the major papilla and delayed perforation were significant risk factors for surgical conversion following AEs. In addition, reliable prevention of delayed perforation is required for 3 days after duodenal ER to prevent the need for surgical interventions.

Effectiveness of clip-and-thread traction-assisted duodenal endoscopic submucosal dissection: a propensity score-matched study (with video).

BACKGROUND AND AIMS: The indications for endoscopic submucosal dissection (ESD) in superficial nonampullary duodenal epithelial tumors (SNADETs) remain controversial because the procedure is technically challenging. Moreover, the effectiveness of clip-and-thread traction-assisted ESD (TA-ESD) for SNADETs has not been assessed. The aim of the current study was to compare the effectiveness of duodenal TA-ESD and conventional ESD for SNADETs. METHODS: SNADETs treated with conventional ESD or TA-ESD between April 2017 and March 2021 at Saitama Medical University International Medical Center were evaluated retrospectively. RESULTS: There were 49 cases of conventional ESD and 32 cases of TA-ESD for SNADETs. Using a propensity score-matched design, we selected 26 pairs of cases with conventional ESD and TA-ESD. In the unmatched cohort, patients treated with TA-ESD were characterized by a higher R0 (no tumor identified at the lateral or vertical margins) resection rate (P = .004), more frequent poor submucosal lifting because of fibrosis (P = .014), and shorter follow-up period (P = .0004) than patients treated with conventional ESD. In the propensity score-matched pairs, patients treated with TA-ESD were characterized by a higher rate of R0 resection (P = .021) and a shorter follow-up period (P = .0061). The findings regarding R0 resection rates were confirmed by multivariate logistic regression models, which found a higher odds ratio (OR) for R0 resection in patients who underwent TA-ESD than in patients who underwent conventional ESD both in the unmatched cohort (OR, 17.0; 95% confidence interval, 1.6-178.8; P = .018) and in the propensity score-matched pairs (OR, 26.7; 95% confidence interval, 1.5-460.2; P = .024). CONCLUSIONS: Our findings suggest TA-ESD may increase the rate of R0 resection in patients with SNADETs in comparison with conventional ESD.

Outcomes of endoscopic resection for superficial duodenal tumors: 10 years' experience in 18 Japanese high volume centers.

BACKGROUND: Data on endoscopic resection (ER) for superficial duodenal epithelial tumors (SDETs) are insufficient owing to their rarity. There are two main ER techniques for SDETs: endoscopic mucosal resection (EMR) and endoscopic submucosal dissection (ESD). In addition, modified EMR techniques, such as underwater EMR (UEMR) and cold polypectomy, are becoming popular. We conducted a large-scale retrospective multicenter study to clarify the detailed outcomes of duodenal ER. METHODS: Patients with SDETs who underwent ER at 18 institutions from January 2008 to December 2018 were included. The rates of en bloc resection and delayed adverse events (AEs; defined as delayed bleeding or perforation) were analyzed. Local recurrence was analyzed using the Kaplan-Meier method. RESULTS: In total, 3107 patients (including 1017 undergoing ESD) were included. En bloc resection rates were 79.1 %, 78.6 %, 86.8 %, and 94.8 %, and delayed AE rates were 0.5 %, 2.2 %, 2.8 %, and 6.8 % for cold polypectomy, UEMR, EMR and ESD, respectively. The delayed AE rate was significantly higher in the ESD group than in non-ESD groups for lesions < 19 mm (7.4 % vs. 1.9 %; P < 0.001), but not for lesions > 20 mm (6.1 % vs. 7.1 %; P = 0.64). The local recurrence rate was significantly lower in the ESD group than in the non-ESD groups (P < 0.001). Furthermore, for lesions > 30 mm, the cumulative local recurrence rate at 2 years was 22.6 % in the non-ESD groups compared with only 1.6 % in the ESD group (P < 0.001). CONCLUSIONS: ER outcomes for SDETs were generally acceptable. ESD by highly experienced endoscopists might be an option for very large SDETs.

Factors affecting complete stone extraction in the initial procedure in short type single-balloon enteroscopy-assisted endoscopic retrograde cholangiography for patients with Roux-en-Y gastrectomy.

OBJECTIVES: This study aimed to evaluate the efficacy and safety of stone extraction in patients who underwent Roux-en-Y gastrectomy using short-type single-balloon enteroscopy (SBE) and to clarify the factors affecting complete stone extraction in the initial procedure. METHODS: The data of patients with Roux-en-Y gastrectomy who underwent endoscopic stone extraction using short SBE between September 2011 and January 2022 was analyzed. RESULTS: Overall, 85 patients were scheduled to undergo stone extraction. 77 patients were intended stone extraction after successful biliary cannulation. The complete stone extraction success in the initial procedure, overall complete stone extraction success including repeated procedures, and adverse event rates were 68.2% (95% confidence interval [CI], 57.2%-77.9%), 87.1% (95% CI, 78.0%-93.4%), and 8.2% (95% CI, 3.4%-16.2%), respectively. Multiple logistic regression analysis indicated that bile duct diameter affected the success of complete stone extraction after successful biliary cannulation in the initial procedure (odds ratio 0.53, 95% CI, 0.30-0.94, p = .03). CONCLUSIONS: Stone extraction in patients with Roux-en-Y gastrectomy using short SBE was effective. Patients with a large diameter bile duct required several sessions for complete stone extraction, suggesting that more dedicated devices are warranted for patients with surgically altered anatomy.

Evaluation of endoscopic ultrasound-guided fine-needle biopsy for preoperative pancreatic solid lesions.

OBJECTIVES: Obtaining an accurate preoperative diagnosis is crucial. This study aimed to evaluate the diagnostic accuracy and utility of endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) for preoperative pancreatic solid lesions. MATERIALS AND METHODS: We retrospectively assessed all patients who underwent endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) or EUS-FNB to evaluate solid pancreatic lesions preoperatively at our center between July 2013 and June 2020. We enrolled 71 patients who underwent EUS-FNA using a 22 G conventional needle (FNA group) and 34 patients who underwent EUS-FNB using a 22 G Franseen needle (FNB group). Overall, 105 patients were analyzed. We employed propensity-matched analysis and adjusted the confounders. RESULTS: No procedural adverse events were encountered. Both groups showed no significant differences in the procedure time, technical success rate, and rate of operator changes from trainee to expert. Regarding diagnostic accuracy, the FNB group (88.2%; 30/34) was higher but not significantly different from the FNA group (85.3%; 29/34) (p > .99). Furthermore, the FNB group (median 2, IQR;2-3) had a significantly lower number of punctures than the FNA group (median 3, IQR; 2-4) (p = .01). CONCLUSIONS: The FNB needle provides higher diagnostic accuracy and requires significantly fewer punctures than conventional needles even at facilities with no available rapid on-site evaluation. Thus, using the FNB needle can be useful for preoperative pancreatic solid lesions.

A retrospective cohort study of factors influencing long procedure times in colorectal endoscopic submucosal dissection.

OBJECTIVE: To evaluate the outcomes and factors influencing colorectal endoscopic submucosal dissection (ESD) with a long procedure time. MATERIALS AND METHODS: In this single-center, retrospective study, we included 1,100 patients with 1,199 lesions who underwent colorectal ESD between April 2016 and December 2020. ESD was performed using an advanced system knife for lesions >20 mm. An S-O clip was used as the traction device. The long-time group (LP; procedure time >120 min) and normal-time group (NP; procedure time <120 min) were compared. RESULTS: The procedure times were 166.86 and 44.72 min in the LP and NP groups, respectively. The completion rate was higher in the NP group (96.5% vs. 83.5%, p = .001); the completed lesions were resected en bloc. Multivariate analysis revealed 18.8% and 7.8% of submucosal fibrosis in the LP and NP groups, respectively (odds ratio [OR] = 2.410, p = .026). Compared to the NP group, the LP group presented larger maximum lesion sizes and higher rates of R1 resection, and traction device use. Time to introduction of traction device use was longer in the LP than in the NP group (126.05 vs. 21.72 min; p < .001). Fibrosis tends to occur cecal lesions (OR 2.436, p = .011) and laterally spreading tumor-non-granular-pseudo-depressed (LST-NG-PD) (OR 2.6181, p = .001). CONCLUSIONS: Lesion size and fibrosis were factors associated with a long procedure time in colonic ESD. For fibrotic lesions (LST-NG-PD and cecal lesions), it is necessary to consider early use of traction devices and advisable to plan a strategy for the use of traction devices.

Status of single-balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography in patients with surgically altered anatomy: Systematic review and meta-analysis on biliary interventions.

BACKGROUND AND AIMS: Endoscopic retrograde cholangiopancreatography (ERCP) in patients with surgically altered anatomy is still challenging. Usefulness of single-balloon enteroscopy (SBE)-assisted ERCP has been increasingly reported. Short SBE is considered beneficial with a 152-cm working length and a 3.2-mm working channel. This has increased the variety of devices that can be used during ERCP procedures. The aim of this pooled analysis was to evaluate the efficacy of SBE-assisted ERCP in patients with surgically altered anatomy and elucidate the current status. METHODS: This systematic review only involved biliary interventions which excluded pancreatic cases. Studies involving SBE-assisted ERCP in patients with Roux-en-Y gastrectomy, hepaticojejunostomy with Roux-en-Y, pancreaticoduodenectomy (Whipple or Child procedure), or Billroth II gastrectomy were analyzed. Enteroscopy, biliary cannulation, and procedural success were assessed by pooling data in a random-effect model, according to the degree of heterogeneity, to obtain a proportion with 95% confidence interval (CI). The outcomes observed for conventional and short SBE cases were also reported. RESULTS: Overall, 1227 SBE-assisted ERCP procedures from 21 studies were included. The pooled enteroscopy, biliary cannulation, and procedural success rates were 86.6% (95% CI, 82.4-90.3%), 90% (95% CI, 87.1-92.5%), and 75.8% (95% CI, 71.0-80.3%), respectively. Adverse events occurred in 6.6% (95% CI, 5.3-8.2%) of the procedures. Although good outcomes were reported for short SBE-assisted ERCP, these should not be directly compared to the outcomes observed for conventional SBE, as they assume different backgrounds and include confounding variables. CONCLUSIONS: Single-balloon enteroscopy-assisted ERCP in patients with surgically altered anatomy on biliary interventions is effective.

Analysis of the factors involved in procedural failure: Endoscopic retrograde cholangiopancreatography using a short-type single-balloon enteroscope for patients with surgically altered gastrointestinal anatomy.

AIM: To analyze factors involved in procedural failure and to discuss responses to procedural failure by using the outcomes of endoscopic retrograde cholangiopancreatography (ERCP) carried out using a short-type single-balloon enteroscope (short SBE) in patients with surgically altered gastrointestinal anatomy. METHODS: The study sample included patients who underwent ERCP-related procedures using a short SBE between September 2011 and September 2018 at our hospital. Outcomes, including procedural success rate, were studied retrospectively to analyze the factors involved in procedural failure. RESULTS: Analysis included 191 procedures carried out in 121 patients. Procedural success rate was 85.9% with an adverse event rate of 8.4%. Causes of procedural failure included malignant biliary obstruction (odds ratio [OR] 2.89, 95% confidence interval [CI] 1.19-7.25, P = 0.02), first ERCP attempt (OR: 5.32, 95% CI: 1.30-36.30, P = 0.02), and Roux-en-Y reconstruction (OR: 0.08, 95% CI: 0.004-0.39, P < 0.001). With regard to the response to failure, in cases of malignant biliary obstruction, reattempted short SBE-assisted ERCP was difficult because of invasion of the small intestine or papilla. A large number of these cases required alternative treatment (10 of 15 cases, 66.7%) using percutaneous transhepatic biliary drainage (PTBD) or endoscopic ultrasound-guided biliary drainage (EUS-BD). CONCLUSION: Endoscopic retrograde cholangiopancreatography using a short SBE is safe and effective, with malignant biliary obstruction being a specific cause of failure. Technical proficiency with different modalities, such as PTBD and EUS-BD, is necessary to respond to failure in these cases.

Efficacy of an over-the-scope clip for preventing adverse events after duodenal endoscopic submucosal dissection: a prospective interventional study.

BACKGROUND: Duodenal endoscopic submucosal dissection (ESD) remains technically challenging, with a high risk of severe adverse events. Because exposure of the duodenal post-ESD mucosal defect to pancreatic juice and bile acid reportedly induces delayed perforation and bleeding, we examined whether defect closure using an over-the-scope clip (OTSC) system was useful for preventing postoperative adverse events. METHODS: From April 2016 to February 2017, a total of 50 consecutive patients with superficial non-ampullary duodenal epithelial tumors (SNADETs) larger than 10 mm, with no more than semi-circumferential spread, were prospectively enrolled in this study. All of the lesions were treated by experienced ESD operators and the post-ESD mucosal defect was closed using OTSCs. RESULTS: All of the SNADETs were completely removed by ESD, with an R0 resection rate of 88.0 %. The mean procedure and closure times were 67.3 ±â€Š58.8 minutes and 9.8 ±â€Š7.2 minutes, respectively. Although complete defect closure was achieved in 94.0 % of the patients (47/50), two patients required surgical conversion. Delayed perforation occurred in only one patient (2.1 %), who did not have successful closure of the defect, as misplacement of the OTSC exposed the muscle layer. Meanwhile, delayed bleeding occurred in three patients (6.3 %); however, the bleeding was easily controlled using endoscopic coagulation. The mean duration of postoperative hospitalization was 5.5 ±â€Š7.2 days. CONCLUSIONS: Prophylactic defect closure using OTSCs may be effective in reducing severe adverse events after duodenal ESD.