Introduction

Gastric variceal bleeding is life-threating condition with high risk of rebleed with challenging management with standard management including cyanoacrylate glue injection. We aimed to compare efficacy and safety of endoscopic ultrasonography (EUS)-guided coil embolization and cyanoacrylate injection versus EUS-guided cyanoacrylate injection alone in management of gastric varices.

Aims & Methods

Single-centre, parallel-randomized controlled trial involving 24 participants with gastric varices (GOV II and IGV I) who were randomly allocated to EUS-guided coil embolization and cyanoacrylate injection (n = 12) or EUS guided cyanoacrylate Injection alone (n = 12). Primary end points were technical and clinical success rates of both procedures. Secondary end points were reappearance of gastric varices during follow-up with rebleeding, and complication.

Results

Average size of varices were almost similar (21mm and 22mm) in both. Mean number of coils required were 2.1 per patient and volume of cyanoacrylate needed was less in combined modality group (2.5ml vs 4ml). Technical success rate was 100% in both groups. Immediate disappearance of varices was observed in 66.67% of patients treated with coils and cyanoacrylate, versus 8.33% of patients treated with cyanoacrylate alone (P=0.009). Rebleeding at 10 months occurred in none of patients treated with combined and 5 of 12 (41.66%) of those treated alone (P=0.03). 1 patient died in only cyanoacrylate group after intervention because of pulmonary embolism.

Conclusion

EUS guided coil embolization with cyanoacrylate injection achieved excellent clinical success, with lower rates of rebleeding than cyanoacrylate treatment alone. Long term follow-up and mean sample required to further Validate our data.

Introduction

Upper gastrointestinal bleeding (UGIB) is associated with an unfavorable prognosis in cancer patients. In biliary tract cancers (BTCs), little is known about the occurrence of UGIB and its prognostic relevance for the course of the disease.

Aims & Methods

The aim of this study was to analyze the prevalence of UGIB in BTC patients, compare therapeutic approaches for efficacy, and identify parameters associated with survival and recurrence rates. This retrospective observational study included all patients with BTCs and UGIB, that were treated in our tertiary care hospital between 2010 and 2023.

Results

A total of 1033 patients with BTC were analyzed. 41 (4.0%) of these patients had a total of 60 bleeding events. At the time of the bleeding event, 30.8% of patients displayed symptoms of shock, and 67.5% received red blood cell transfusions. The most common causes of bleeding were tumor infiltration (24.4%), variceal bleeding (19.5%), or ulcer bleeding (14.6%). At the time of presentation, 56.4% of patients had stage IV cancer. Most patients had perihilar (39.0%) or intrahepatic (34.1%) cholangiocarcinoma. At index bleeding, endoscopic treatment was performed in 41,5% of cases, while conservative measures (53,7%) or interventional radiological procedures (4.9%) were used in the remaining cases. In cases of bleeding caused by tumor infiltration, endoscopic hemostasis was usually performed using hemostatic powder (18.8%) or clip application (12.5%). Admission to an intermediate or intensive care unit (odds ratio 6.7; 95% CI 1.5 – 33.9) as well as symptoms of shock at the time of the bleeding event (odds ratio 2.6; 95% CI 0.5 – 15.6) were risk factors of rebleeding within 14 days. In patients with UGIB due to tumor infiltration, bleeding recurred after endoscopic therapy in 33.3% of cases. With conservative therapy, the recurrence rate was 28.6%. Survival of Patients with UGIB due to tumor infiltration was significantly shorter compared with patients having non-tumor-associated UGIB (median survival 0.93 vs. 6.5 months, log-rank test p = 0.018).

Conclusion

UGIB is a rare but serious complication in patients with BTC. Patients with major bleeding episodes should be closely monitored for short-term rebleeding. The occurrence of UGIB due to tumor infiltration is associated with adverse outcomes and significantly shortened survival time.

Introduction

Recent advances in endoscopic imaging have improved the diagnostic accuracy for superficial non- ampullary duodenal epithelial tumors (SNADETs). Endoscopic resection is the treatment of choice for these lesions and endoscopic mucosal resection (EMR) is the commonly used technique. Endoscopic resection with the use of a specific distal attachment (cap-assisted EMR (CEMR)) has been reported as a safe and effective method for SNADETs.¹ However, there is limited data on the technical aspects of the same. Duodenal resections have a high risk of delayed bleeding and perforation probably due to direct exposure of ulcer to biliary and pancreatic juices. Hence, appropriate closure is absolutely essential. We have previously reported safety of closure of duodenal endoscopic resections using over-the-scope and conventional clips.² We now report on the safety and efficacy of using only hemoclips for defect closure of CEMR of SNADETs.

Aims & Methods

This prospective study aimed to evaluate the safety and efficacy of using only hemoclips for closure of SNADETs resected by CEMR. 21 patients from December, 2022 to March, 2023 who underwent the procedure at our center for lesions <10mm in size were included in the study. The pimary outcome was post procedural adverse events that included the rate of delayed bleeding and perforation, and ulcer dehiscence. The secondary outcomes were en bloc and R0 resection rates, complete closure rate, number of clips used, total procedure time, and duration of hospital stay. Descriptive statistics were used to summarize the outcomes.

Results

16 males and 5 females with median age of 59(38-75) years underwent CEMR for SNADETs and closure with hemoclips only. Paris classification morphology of 67.7% lesions was 0-IIa and 33.3% lesions was 0-IIc. All lesions of median size 4(2-6) mm were successfully resected en bloc. The median specimen size was 14(12-25) mm and the median number of hemoclips used for complete closure were 7(5-11). The mean resection and closure times were 5.7+1.8 and 9.3+3.9 minutes respectively. The mean total procedure time was 14.9+4.9 minutes. Complete closure rate was 100% with no dehiscence seen on check endoscopy (done one day post index procedure). Pathology revealed 42.9% of the lesions having low grade dysplasia and 57.1% having high grade dysplasia with R0 resection rate being 100%. There was no delayed bleeding or perforation. The mean duration of post procedure hospitalization was 2.2+0.9 days.

Outcomes of closure of CEMR for SNADETs with hemoclips only

Conclusion

Our single center study is the first to demonstrate an excellent safety profile for the use of only hemoclips in closing post CEMR defects of SNADETs. It is easy to perform, requires no additional accessories, and reduces procedure time and cost compared to other available methods of closure. Furthermore, in lesions under 10mm, CEMR was effective at en-bloc resection with favorable procedure time and duration of post procedural hospital stay. Larger scale studies may be warranted to confirm this method of resection for SNADETs and safety of closure technique.

References

1. Jamil LH, Kashani A, Peter N, et al. Safety and efficacy of cap-assisted EMR for sporadic nonampullary duodenal adenomas. Gastrointest Endosc 2017; 86:666-72.
2. Ohata K, Sakai E, Suzuki Y et al. Risk factors of delayed bleeding after endoscopic resection of superficial non-ampullary duodenal epithelial tumors and prevention by over-the-scope and conventional clipping. Dig Endosc 2021; 33: 390–8.

Introduction

Insulinomas are rare, functioning neuroendocrine neoplasms that cause non-ketotic hypoglycemia due to hyperinsulinism. Surgery is considered the gold-standard treatment, although endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA) has been recently described as a less invasive, efficient therapeutic option for these tumors. In this study, we aim to compare post-procedural outcomes of surgical resection versus EUS-RFA for pancreatic insulinomas.

Aims & Methods

All patients who underwent surgical resection or EUS-RFA for pancreatic insulinoma in our Institution were included in the study, and data from all procedures were retrospectively recorded and statistically analyzed. EUS-RFA was indicated for all subjects either unfit for surgery or unwilling to undergo surgical treatment. Patients’ baseline characteristics, location, size of insulinomas, procedural time, and intra- and postoperative outcomes were compared.

Results

From April 2012 to July 2022, 11 and 10 patients with pancreatic insulinoma underwent surgical resection and EUS-RFA, respectively. The median age was 65.5 (51-84) and 37 years (28-72, p<0.001) for the EUS-RFA and surgery cohorts, respectively. As a whole, 15 (71.4%) out of 21 were female. The median tumor size was 15mm (8-30) for the surgical group and 11mm (8-19) for the EUS-RFA group (p=0.17). The majority of the insulinomas were located in the pancreatic body (28.6%) and tail (28.6%), with no statistical difference between the two groups (p=0.16). Operative time was significantly longer in the surgical population (280min, 120-372) as compared to the endoscopic one (28min,18-40, p<0.001). Clinical success, defined as the normalization of glucose blood levels, was reached in all cases. The complication rate was significantly higher in the surgical group compared to the endoscopic group (7-63.6% vs 1-10%, p=0.01). Specifically, 7 patients in the surgical cohort developed a pancreatic fistula while one patient in the EUS-RFA population had self-limiting bleeding after the procedure. One patient of the surgical cohort underwent reoperation for an infected abdominal fluid collection.

Table 1. Characteristics of patients classified by treatments.

Conclusion

As compared to surgical resection, EUS-RFA for pancreatic insulinomas may be considered a safe and efficient treatment option with a shorter operative time and a lower rate of related complications. Prospective comparative studies are needed to ascertain the role of EUS-RFA as a treatment of choice for selected patients with pancreatic insulinoma.

References

Fahmawi Y, Mehta A, Abdalhadi H et al. Efficacy and safety of endoscopic ultrasound-guided radiofrequency ablation for management of pancreatic lesions: a systematic review and meta-analysis. Transl Gastroenterol Hepatol. 2022 Jul 25;7:30.
Zhao YP, Zhan HX, Zhang TP et al. Surgical management of patients with insulinomas: Result of 292 cases in a single institution. J Surg Oncol. 2011 Feb;103(2):169-74.

Introduction

While randomized studies have shown that Amgevita (an adalimumab biosimilar) and Humira (adalimumab originator) are equivalent, concerns persist among patients and prescribers as to its efficacy. Patients switching to a medicine they perceive as lower cost may experience a ‘nocebo’ effect, whereby expectations of poorer efficacy may lead to worse clinical outcomes, resulting in an unmeasured health economic burden.

Aims & Methods

70 patients partook in a biosimilar switch study at our centre in August 2020, undergoing a change in treatment from Humira to Amgevita. Baseline clinical data obtained included faecal calprotectin, drug and drug antibody levels, Harvey-Bradshaw (HBI) and Partial-Mayo scores. Patient-Reported Outcomes (PROs) were recorded through the IBD control-8 (IBDC8) and IBCD visual analogue scale (IBDQ-VAS). Patients took psychometric tests 8 weeks pre-switch, including the ‘Beliefs about Medicines’ questionnaire (BMQ), used to assess beliefs about prescribed medications, the ‘Health Anxiety Index’ (HAI), used to identify patients with high levels of concern about their health, and the EQ-5D questionnaire, used to measure health-related quality of life. The original study found no significant differences in clinical and PROs at 8-week follow-up. We planned to conduct a 32-month follow-up on these patients to examine for temporal changes in outcomes, and whether certain variables could predict the patients experiencing a ‘nocebo’ effect. Approval was obtained from the hospital ethics committee. Patient information from the original study was stored on an excel database. We retrospectively obtained clinical data from electronic records and lab data. Questionnaire results were obtained from clinic appointments.

Results

70 patients were included in the study. 41 male, 29 female. 54 patients had Crohn’s, 13 UC, and 4 indeterminate colitis. 25.7% of patients reported adverse events post-switch, with 33.3% of these patients switching back to Humira. The most common side effects were skin related (8.6%), injection site related (5.7%), and headaches (2.8%). 8.6% of patients felt the medication to be less effective without specific symptoms. 32-months post switch, 72.7% remained on Amjevita, 9.1% had switched back to Humira, 7.6% had switched to another biologic as clinical non-responders, 10.6% had stopped biologic treatment due to surgery or clinical remission.
Median scores were calculated at 8 weeks pre and post-switch, and at 32 months. HBI scores were 2, 1 and 1 respectively, with scores of 1, 0 and 0 in the switchback group. IBDC8 scores were 12, 13 and 14 overall, with scores of 12, 10 and 14 in the switchback group. IBDQ-VAS scores were 87, 80 and 90 overall, with scores of 100, 100 and 85 in the switchback group. Median HAI scores were lower in the switchback group; scoring 12 versus 17 overall. Median scores in four domains of the BMQ questionnaire; general harm, general overuse, specific concerns and specific necessity were lower in the switchback group. Scores were 12, 12, 8, 7, versus overall scores of 21, 14, 10, and 9 respectively, indicating more negative attitudes towards medicines in the switchback group.

Conclusion

Our study found no negative impact in clinical outcomes and PROs in patients switching from Humira to Amgevita at 32-months post-switch. Patients that had more negative attitudes to medicines in the BMQ questionnaire were more likely to switchback to Humira suggesting a nocebo effect. Enhanced patient education may help mitigate the nocebo effect observed in our study and enhance the success rate of future biosimilar switch trials.