Introduction

The need for endoscopic necrosectomy (EN) has increased dramatically, as endoscopic EUS-guided drainage has become gold standard for treatment of pancreatic walled-off-necrosis (WON)[1,2]. Although snares and baskets are commonly used in EN procedures, they can be ineffective and dedicated instruments specifically designed for EN are scarce. Recently, an innovative powered endoscopic debridement system (EndoRotor, Interscope Inc., Northbridge, MA, USA) designed to excise and remove necrotic tissue within the WON was introduced specifically for EN with promising results[3,4]. While the first generation EndoRotor catheter was limited to 3.2 mm diameter, a larger catheter that fits into a large-channel gastroscope with a working channel of 6.0 mm has now been introduced. This study evaluates the clinical outcomes, safety, and feasibility of the novel 6.0 catheter for EN of WON.

Aims & Methods

This retrospective study was performed using prospectively collected data from all patients who underwent EN with the 6.0 catheter between December 2021 and March 2023 at Gastro Unit, Copenhagen University Hospital Hvidovre, a tertiary referral center in Denmark. All patients with symptomatic WON and need for necrosectomy were considered eligible for this study. Technical feasibility, safety, and clinical outcomes were evaluated.

Results

Sixteen patients underwent a total of 25 EN procedures with the 6.0 catheter. The mean age of the patients was 51.8 years (SD 17.7 years) and 11 (68.8%) were male. The etiology of the acute necrotizing pancreatitis was alcohol in 4 patients (25.0%), gall stones in 7 patients (43.8%), post-endoscopic retrograde cholangiopancreatography (ERCP) in 3 patients (18.8%), and idiopathic in 2 patients (12.5%). The mean size of the WON was 27.5 cm (SD 10.5 cm). The median computed tomography severity index (CTSI) was 8.5 (P25-P75: 6.0-9.0) and median modified CTSI (mCTSI) was 9.0 (P25-P75: 8.0-10). Two patients did not achieve clinical resolution (12.5%), as they died from multisystem organ failure before resolution of the WON was achieved. The median length of stay in hospital for the patients who achieved clinical resolution was 56.0 days (P25-P75: 36.5-96.0 days) and the median number of necrosectomy procedures performed to achieve clinical resolution was 5.0 (P25-P75: 2.0-8.5). All patients had EN procedures performed with snares in addition to the procedures with the powered debridement system. Five patients had necrosectomy performed with the 3.2 catheter (31.0%) as well as the 6.0 catheter. The median duration of EN with the 6.0 catheter was 60.0 minutes (P25-P75: 45.0-100 minutes) per procedure.
A device-related adverse event was noted in one instance (4.0%). The patient exhibited symptoms of peritoneal reaction in the hours following the procedure, which may have been caused by perforation of the WON into the peritoneal cavity. The patient was treated with laparoscopic peritoneal lavage and drainage and recovered without further interventions. No other procedure-related adverse events were identified. Malfunction of the catheter was observed in 7 procedures (28.0%).

Conclusion

To perform necrosectomy procedures optimally, dedicated endoscopic instruments designed for debridement of pancreatic WON are required. This study suggests that EN with the novel EndoRotor 6.0 catheter is safe and feasible with promising clinical results for EN of pancreatic WON. To assess the efficacy relative to standard techniques, comparative studies are warranted.

References

[1] Karstensen JG, Novovic S, Hansen EF, et al. EUS-guided drainage of large walled-off pancreatic necroses using plastic versus lumen-apposing metal stents: A single-centre randomised controlled trial. Gut 2022; 0: 1–7. doi:10.1136/gutjnl-2022-328225
[2] Ebrahim M, Werge MP, Hadi A, et al. Clinical outcomes following endoscopic or video-assisted retroperitoneal management of acute pancreatitis with large (>15 cm) walled-off pancreatic necrosis: Retrospective, single tertiary center cohort study. Dig Endosc 2022; 34: 1245–1252. doi:10.1111/den.14295
[3] Stassen PMC, de Jonge PJF, Bruno MJ, et al. Safety and efficacy of a novel resection system for direct endoscopic necrosectomy of walled-off pancreas necrosis: a prospective, international, multicenter trial. Gastrointest Endosc 2022; 95: 471–479. doi:10.1016/J.GIE.2021.09.025
[4] Wiel SE van der, May A, Poley JW, et al. Preliminary report on the safety and utility of a novel automated mechanical endoscopic tissue resection tool for endoscopic necrosectomy: a case series. Endosc Int Open 2020; 08: E274–E280. doi:10.1055/A-1079-5015

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) is a minimally invasive endoscopic procedure that is crucial for pancreato-biliary diseases and selective cannulation is the most important step. However, even an experienced endoscopist can face cannulation failure in up to 15-30% of cases in the first ERCP when standard methods alone are used.¹ Many studies suggested the various needle knife fistulotomy or papillotomy as an alternative technique in difficult cannulation cases.^2,3 However, needle knife papillotomy (NKP), which is modified technique with needle knife has not been evaluated well.

Aims & Methods

To evaluate the clinical outcomes and adverse events of bile duct cannulation by NKP, we performed a retrospective review on medical records of all ERCP cases in Sheikh Khalfia Specialty Hospital, UAE. For six years, Sphincterotomy (SPT) naïve patients except altered-anatomy cases were enrolled and their procedure times, cannulation success rates, radiation exposures, and adverse events were measured between the procedure time matched two cohort group of SPT only and rescue NKP.

Results

In total 416 ERCP cases, 43 procedure time matched cases were selected among 352 (84.7%) SPT only cohort and 43 cases from 64 rescue NKP cohort. Biliary cannulation was succeeded in all cases (100%) by using SPT cannulation with rescue NKP technique without failure. There was no differences in cumulative radiation doses, cannulation time, and adverse event rates in rescue NKP group compared to SPT only group: Post-ERCP hyperamylasemia/hyperlipasemia (16.5% vs. 34.8%, p=0.080), pancreatitis (3.9% vs. 4.3%, p=0.883), cholangitis (4.7% vs. 4.3%, p=0.695), and no perforation case was noticed in both groups.

Conclusion

The SPT with rescue NKP technique can be used in the difficult biliary cannulation cases during ERCP safely and effectively.

References

(1) Testoni PA , Testoni S , Giussani A .
Difficult biliary cannulation during ERCP: how to facilitate biliary access and minimize the risk of post-ERCP pancreatitis.
Dig Liver Dis 2011;43:596–603
[2] Testoni PA , Mariani A , Aabakken L , Arvanitakis M , Bories E , Costamagna G,et al.
Papillary cannulation and sphincterotomy techniques at ERCP: European Society of Gastrointestinal Endoscopy (ESGE) clinical guideline.
Endoscopy 2016;4 8:657–6 83 .
[3] Lopes L , Dinis-Ribeiro M , Rolanda C .
Early precut fistulotomy for biliary access: time to change the paradigm of "the later, the better"?
Gastrointest Endosc 2014;80:634–641 .

Introduction

Gastroenterology is a medical specialty that includes several areas of study. Endoscopy occupies a central role in professional practice, whether in hospitals or in the private sector. The quality of initial training and the different needs of trainees are key to the quality of care delivered to the population. This study aims to assess endoscopic training experience during fellowship.

Aims & Methods

This is a cross-sectional, multicenter study conducted on gastroenterology residents practicing endoscopy and in the final phase of their curriculum (6th, 7th and 8th semesters). Postgraduated doctors have been excluded from the study. An electronic survey made by Google Forms and was sent nationwide on January 9, 2024. The survey consisted of 42 questions divided into 3 parts: The first part focused on the participants' socio-demographic data and their endoscopic experience, the second part focused on the quality of training of core endoscopic skills (cognitive and motor skills) during fellowship where a 5-point Likert scale was used to express residents' satisfaction with their skills, ranging from 1="very dissatisfied", 2="dissatisfied", 3="neither satisfied nor dissatisfied", 4="satisfied" and 5="very satisfied". The third part included questions in which participants expressed their needs and expectations for improving their training in endoscopy. A statistical analysis using the Student-t test and the Fisher’s exact test were performed. P values of <0.05 were considered statistically significant. Data were analyzed using Jamovi (Version 2.3).

Results

We were able to collect data from 56 respondents. Most were female residents n=40 (71.4) with a mean age of 29.2 ± 2.5 years. The majority of fellows started practicing EGD in their 4th semester (91.1%), and colonoscopy in their 6th semester (57%). On average, the fellows are supervised by 5 senior doctors, including 2 who practice interventional endoscopy. Furthermore, 37.5% of participants report performing approximately more than 100 EGDs, 14.2% more than 100 colonoscopies, 80.4% report that they have performed less than 20 endoscopic variceal ligation and 14.3% have performed more than 10 polypectomies. An average rating score of 3.34 (1= very dissatisfied; 5= very satisfied) concerning the quality of training and feedback on cognitive aspects of endoscopy was found and we reported greatest emphasis for Procedure indication/contraindication and least on Capsule endoscopy interpretation.
The quality of training in technical aspects of endoscopy was rated higher (average rating score of 3.5). We reported greatest emphasis for Withdrawal/mucosal inspection and least on Esophageal dilation.
A significant association between motor skills and cognitive skills was found with a p<0.001.
Finally, to improve their training, 87.5% of respondents considered simulation to be important/very important, 98.2% of respondents intend to complete their endoscopy training at the end of their curriculum, and 87.5% are prepared to finance such a project (median: 1000 USD [1000;3000]).

Conclusion

Despite a significant improvement in training sites and technical facilities, training in endoscopy in healthcare institutions does not yet provide all the cognitive and technical skills required to enable fellows to be fully autonomous. With the development of endoscopic procedures, it seems essential for fellows to be able to perform more standard endoscopic procedures such as polypectomy and mucosectomy by the end of their curriculum. This may involve introducing regular endoscopy conferences and simulation training as a part of the curriculum.

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.

Clinical Case Summary

A 68-year-old woman presented after 24 hours of painless jaundice, preceded by 48 hours of dark urine and pale stools without pruritis. No history of weight loss, recent foreign travel, or high risk behaviours. She denied any illicit drug or alcohol abuse. Her co-morbidities included pre-diabetes, and obesity and only took over-the-counter vitamin supplementation with no new or regular prescribed therapies. On clinical examination, she was fully alert with jaundice with no stigmata of chronic liver disease and haemodynamic stable.

Liver tests at presentation (normal in 2020) were ALT 766 U/L, AST 984 U/L, bilirubin 463, ALP 314 U/L. PT 35.3s, APTT 45.5s, TT 26.2s and albumin was 33 g/L. Haemoglobin (139 g/L), platelet count (158 x109/L), and normal eosinophil count (0.89 x109/L). Renal function was unremarkable. Arterial blood gas demonstrated a pH 7.4, Lactate 1.8, glucose 6. CT scan demonstrated moderate volume ascites and a grossly dilated gallbladder. No intra- or extra-hepatic duct dilatation and patent vasculature. Homogenous ANA 1:400, strongly positive SMA, polyclonal gammopathy (IgG 18.8, IgM 5.5, IgA 4.2) and negative AMA/ LKM. Viral hepatitis screen was negative. Given the severity of hepatic failure, she was referred for consideration of transplantation.

This lady presented with an acute hepatocellular pattern of liver injury with hepatic failure. It came to light that her injury was a consequence of exposure to ashwagandha. Although her exposure was in 2021, a latency period prior to drug-related injury is not unusual. Previous case series have shown similar patterns of injury with ashwagandha but no hepatic failure.

1. How do we overcome the challenges distinguishing drug-induced liver injury as a cause of acute hepatic failure, particularly when markers of alternative aetiology are present?
2. What is the role of steroids in patients ?
2. What is the relationship between DILI from herbal/ dietary supplementation and acute liver failure?

References

1. Katarey D, Verma S. Drug-induced liver injury. Clin Med. 2016;16(Suppl 6):s104-s109. doi:10.7861/clinmedicine.16-6-s104
2. Chalasani N, Bonkovsky HL, Fontana R, et al. Features and Outcomes of 899 Patients With Drug-Induced Liver Injury: The DILIN Prospective Study. Gastroenterology. 2015;148(7):1340-52.e7. doi:10.1053/j.gastro.2015.03.006
3. Paul S, Chakraborty S, Anand U, et al. Withania somnifera (L.) Dunal (Ashwagandha): A comprehensive review on ethnopharmacology, pharmacotherapeutics, biomedicinal and toxicological aspects. Biomed Pharmacother. 2021;143:112175. doi:10.1016/j.biopha.2021.112175
4. Mandlik Ingawale DS, Namdeo AG. Pharmacological evaluation of Ashwagandha highlighting its healthcare claims, safety, and toxicity aspects. J Diet Suppl. 2021;18(2):183-226. doi:10.1080/19390211.2020.1741484
5. Björnsson HK, Björnsson ES, Avula B, et al. Ashwagandha-induced liver injury: A case series from Iceland and the US Drug-Induced Liver Injury Network. Liver Int. 2020;40(4):825-829. doi:10.1111/liv.14393