Introduction

ERCP is a high risk procedure yet, despite a standards framework published in the UK in 2014, practice and facilities vary. As part of an on-going BSG Endoscopy Quality Improvement Programme, we aim to describe current ERCP practice in the UK and benchmark this where possible against prior published frameworks and standards.

Aims & Methods

An anonymised survey link was emailed to all independent ERCP practitioners in the UK and a further survey was sent to all organisations in the UK in which ERCP is carried out. Multiple reminders and individual contacts were used to maximise response rate.

Results

491 ERCP practitioners were identified, of whom 386 (78%) responded. 171 organisations providing ERCP were identified with a 100% response rate. 77% of units complete more than 150 ERCPs annually (Table 1), with 13% performing>501. 34% of ERCP practitioners perfrom 101-150 ERCPs annually, with 28% performing >151. 84%of those performing ERCPs are consultant physicians. 31% of individual ERCP practitioners perform EUS. 56% of organisations provide EUS, with an option to provide combined EUS/ERCP lists in 38%. 39% of responders work within formal or informal regional networks that support cross-cover of clinicians.
Cases are selected for listing following review by a specialist ERCP consultant in 85% of organisations. 33% of organisations have a dedicated ERCP/ benign MDT. Hospital in-patients are routinely reviewed by an ERCP consultant, fellow or specialist nurse before ERCP in 61% of organisations. In 64%, there is a system for routine pre-assessment of outpatients by trained nurses. A team briefing involving all members of the ERCP team is always carried out prior to an ERCP list in 74% of organisations.
75% of organisations have written policies and guidelines covering clinical pathways for ERCP, with 44% having written guidance that all eligible patients undergoing ERCP should receive rectal NSAIDS, 23% having written policies on requesting removal of temporary stents and 3% having written policies on the insertion of pancreatic ducts (PD) stents in cases with two or more inadvertent guidewire insertions or opacification of the PD.
90% of units collect annual ERCP quality assurance (QA) data for the unit and consultant ERCP specialists. 37% of organisations regularly receive referrals from neighbouring hospitals - 80% of these organisations collect mortality and morbidity data (20% do not). QA data points are collected manually in 51% of organisations and are reviewed in dedicated ERCP audit time-outs in 25% of organisations. 66% of ERCP practitioners feel their time for ERCP-related governance and audit is inadequate.

Conclusion

Consultant physicians carry out the bulk of ERCP in the UK. Whilst there are high volume units, there are units and individuals that perform low numbers. Two-thirds work within formal or informal regional networks. ERCP vetting is performed by ERCP specialists in the majority but not all cases, with less than a third having access to a dedicated ERCP/ benign MDT. There is variation in the provision of policies for clinical pathways. QA data is not collected globally, and we highlight a need for more dedicated time for ERCP audit and governance.

Introduction

Endoscopic ultrasound-guided fine-needle aspiration/biopsy (EUS-FNA/B) has been widely used for the diagnosis of solid pancreatic lesion. Studies have shown that the wet suction technique in EUS-FNA generates better histologic diagnostic accuracy and specimen quality than the dry suction technique. However, conclusions of wet suction on the diagnostic accuracy of EUS-FNB are still controversial. Besides, the optimal number of passes for EUS-FNB has not been determined. We aimed to design a multicenter randomized trial to compare the diagnostic accuracy of dry suction versus wet suction technique in solid pancreatic lesions using 22G Franseen needles and determine the optimal number of passes required for EUS-FNB without onsite cytopathologist.

Aims & Methods

This is a multi-center, open-label, randomized controlled and non-inferiority trial with two parallel groups. The patients with solid pancreatic lesion will undergo EUS-FNB using 22G Franseen needle in 4 tertiary hospitals in China and will be randomly assigned to the dry suction group and wet suction group in a ratio of 1:1. The primary endpoint of this study is to compare the diagnostic accuracy of EUS-FNB for solid pancreatic lesions using the dry or wet suction technique. Secondary endpoints include the optimal number of needle passes, sensitivity, specificity, specimen quality, time of the procedure, and rates of complications.

Results

Of the 195 patients undergoing EUS-FNB enrolled in the final analysis, 96 were randomized to the dry suction group and 99 to the wet suction group. The diagnostic accuracy was 98.95% and 98.98% in the dry and wet groups, respectively, with a 0.05% difference in accuracy between the study groups (two-sided 90% CI, -4.88% to 4.82%, P=0.989). Diagnostic accuracy was shown to be non-inferior because the lower bound of the 90% confidence interval falls to the right of the non-inferiority margin. Compared to the wet group, no significant differences were seen in the sensitivity (98.80 % vs 98.77 %, P = 1) and specificity (100 % vs 100 %, P = 1) in the dry suction group. The overall adverse event rate was 0.52 %, with 0 and 1.02 % in the dry and wet groups, respectively (P = 1). In terms of specimen quality, no significant differences were also seen in the two groups in sample adequacy (100 % vs 98.3 %, P = 0.492) and level of blood contamination (P = 0.319). In terms of puncture time in the dry group compared to the wet group, there was no statistically significant (18.82±8.21 min vs. 18.92±8.99 min, P=0.952), but the wet suction required more time to prepare the saline and the needle. No significant improvement in diagnostic accuracy was seen with the 2nd needle compared to the 1st needle of EUS-FNB (97.41% vs 95.34%，P=0.276), and no significant improvement in diagnostic accuracy was seen with the 3rd shot compared to the 2nd shot of EUS-FNB (98.96% vs 97.41%，P=0.446).

Conclusion

The dry suction technique is non-inferior to the wet suction technique, while saving steps and time. In the absence of rapid on-site evaluation (ROSE), only 1 pass was required to reach the diagnositic accuracy≥ 95% using EUS-FNB with Franseen needle.

Disclosure

The authors disclose no conflicts.

Introduction

Endoscopic colonic stenting is a treatment method in which a colonoscope is used to insert a self-expandable metal stent (SEMS) into a stenotic site and allow its expansion to alleviate colonic obstruction and permit urgent colonic decompression. It is an effective and extensively practiced minimally invasive procedure compared with emergency surgery. However, perforation, stent migration, and reocclusion may occur. Perforation is particularly a serious adverse event with a mortality rate of 50%. There are three possible causes of perforation:
(1) Local perforation due to stimulation of the stent itself directly into the intestinal tract;
(2) Perforation due to guidewire or catheter manipulation during stent insertion; and
(3) Perforation due to increased pressure in the intestinal tract at the oral side of the obstruction (especially in the cecum) caused by air supply during colonoscopy insertion.
For the first possible cause, an improved colonic stent was developed to reduce irritation to the intestinal tract, and for the second possible cause, a strategy for safe stent insertion was established.
However, perforation due to the third possible cause remains a concern, and appropriate countermeasures should be urgently developed.
In endoscopic colonic stenting, we hypothesized that colonoscope insertion using the gel immersion method, which uses a recently developed endoscopic view-securing gel, would allow safe and rapid access to the lesion without increasing intestinal pressure, thereby decreasing the incidence of perforation.

Aims & Methods

This study aimed to clarify the usefulness of the gel immersion method during colonoscope insertion with endoscopic view-securing gel for colonic stenting. Eight patients in whom colorectal stenting was performed using the gel immersion method between May 2022 and January 2023 were included.
The primary endpoint was the endoscopic lesion reach rate, and the secondary endpoints were the technical and clinical success rates of SEMS deployment, colonoscope insertion time, total procedure time, and adverse event rate.

Results

Of the included patients, four were males (50%), and the mean age of patients was 67.6 ± 15.6 years. Seven patients (87.5%) had colorectal cancer and one patient (12.5%) had gastric cancer. The cancer was localized at the following sites: sigmoid colon in three patients, descending colon in three patients, transverse colon in one patient, and ascending colon in one patient. The purpose of SEMS deployment was bridge to surgery in four (50%) and palliation in four (50%) patients. In all cases, the endoscope was inserted without the preparation and insertion of the endoscope into the lesion at the origin of the obstruction without insufflation, and the endoscopic lesion reach rate was 100% (8/8). No worsening of intestinal dilatation was observed. The technical and clinical success rates each were 100% (8/8). The scope insertion time was 9.8 ± 5.2 min, total procedure time was 27.3 ± 6.5 min, and the adverse event rate was 0% (0/8).

Conclusion

For endoscopic colonic stenting, endoscope insertion using the gel immersion method could be performed safely and effectively and has the potential to become the standard method.

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

Uncontrolled sepsis following leak from major oesophago-gastric surgery is a devastating condition with increased morbidity and mortality and intensive care stay. We hypothesised that endoluminal vacuum therapy (EVT) could be used in the prophylactic setting to provide source-control, prevent mediastinitis and minimise sepsis related morbidity from leaks.

Aims & Methods

An ad-hoc EVT device was created using VAC granufoam (KCI) and a nasogastric-tube (16/18Fr), and placed intraluminally across the high risk anastomosis/area of repair. Continuous negative pressure (75–125mmHg) was applied. Assessment of the repair site/anastomosis was performed by radiology, endoscopy, clinical assessment or a combination following cessation of EVT and removal of the prophylactic EVT device.

Results

Twenty-seven patients had prophylactic EVT; M:F ratio was 3:1 and the median age was 68 years (range: 41-82 years). Twenty-six patients had cancer resections while 1 had benign surgery. The rationale for prophylactic EVT included preoperative factors (10), intra-operative factors (16) or both (1). The median duration of prophylactic EVT was 7 days (range: 4-14 days). The median length of stay was 19.7 days (range: 6-96 days), the two longest admissions were unrelated to the anastomosis (prolonged chyle leak, and long-term-sequelae of life-threatening bleed). One patient developed full-thickness microleak at endoscopic evaluation, remained clinically well with no systemic signs of sepsis, and was successfully managed with luminal EVT for a further 6 days in a ward-based environment. Though prophylactic EVT did not prevent the leak, it significantly minimised the systemic hit that traditionally results from leak and associated mediastinal sepsis.

Conclusion

Prophylactic EVT is a useful adjunct for management of patients with a high-risk for leak and can serve as a risk reducing strategy in select cases. There are no short-term complications, yet the additional morbidity, mortality, and length of stay associated with a fully-fledged leak is avoided. Our results lay the foundation for the use of prophylactic EVT in randomised controlled trials to further standardise selection criteria, assess longer term potential patient benefit and impact on survivorship.

References

1. Pournaras DJ, Hardwick RH, Safranek PM, Sujendran V, Bennett J, Macaulay GD, Hindmarsh A. Endoluminal vacuum therapy (E-Vac): a treatment option in oesophagogastric surgery. World journal of surgery. 2018 Aug;42:2507-11.
2. Afzal Z, Gourgiotis S, Hardwick R, Safranek P, Sujendran V, Bennett J, O'Neill R, Noorani A, Hindmarsh A. O-EGS08 Endoluminal Vacuum Therapy (EVT) for leaks in the upper gastrointestinal (UGI) tract; 10-years’ experience in a specialist Oesphagogastric centre. British Journal of Surgery. 2021 Dec 1;108(Supplement_9):znab429-022.
3. Müller PC, Morell B, Vetter D, Raptis DA, Kapp JR, Gubler C, Gutschow CA. Preemptive endoluminal vacuum therapy to reduce morbidity after minimally invasive Ivor Lewis esophagectomy: including a novel grading system for postoperative endoscopic assessment of GI-anastomoses. Annals of Surgery. 2021 Nov 1;274(5):751-7.