Introduction

The prevalence of biliopancreatic malignancies is steadily increasing. Most patients are inoperable due to the typically advanced stage of the disease at the time of diagnosis and require biliary drainage. Despite numerous large-scale studies, the identification of predictive factors for survival in these cancers to improve their prognosis remains a challenge.
The aim of our study was to evaluate the survival of patients who underwent biliary stenting as part of the management of unresectable biliopancreatic malignancies and to assess the factors influencing the survival rate.

Aims & Methods

We conducted an observational cohort study between January 1, 2021, and March 28, 2024. All patients who underwent biliary drainage for obstructive jaundice due to biliopancreatic cancer (pancreatic head adenocarcinoma, peri-hilar cholangiocarcinoma, gallbladder cancer, ampulloma) were included. Contraindications to palliative chemotherapy were poor general condition (ECOG/WHO performance status 3 or more) and hyperbilirubinemia due to inadequate biliary drainage.

Results

82 patients were included in our study. The mean age in our series was 63.4 +/- 12 years. The sex ratio was 1. The median survival was 350 days (95% CI 268 – 514). 49.4% had pancreatic head adenocarcinoma, 30.6% had cholangiocarcinomas, 10% had ampullomas, and 10% had gallbladder cancer.
The median survival for pancreatic head adenocarcinoma was 450 days vs. 562 days for ampullomas, 356 days for cholangiocarcinomas, and 301 days for gallbladder cancer.
The type of cancer did not have a statistically significant difference on median survival (p = 0.95).
15% of patients had failed ERCP and underwent percutaneous biliary drainage. They had a 2.5 times higher risk of death (RR = 2.57, 95% CI 1.26-5.25, p = 0.01). Indeed, the median survival without death in cases of percutaneous drainage was 39 days vs. 375 in cases of successful ERCP (p = 0.007).
65% of patients were able to undergo palliative chemotherapy after stenting. The median survival with chemotherapy was 562 days vs. 30 days for patients who could not initiate it (p < 0.001). The latter had a 10 times higher risk of death in the month following stent placement (RR = 10.7, 95% CI 5.23-21.9, p < 0.001).
In our series, the presence of pancreatic head adenocarcinoma was associated with a higher probability of receiving chemotherapy (p = 0.04). However, it did not have a significant impact on median survival.
In multivariate analysis, only palliative chemotherapy seemed to improve the survival median (p < 0.001), while recurrence of jaundice and stent occlusion were associated with death (p = 0.03).

Conclusion

According to the results of our study, the prognosis of unresectable biliopancreatic cancers is poor but appears to be improved by a successful biliary stenting. Patients in whom biliary stent placement was a bridging procedure that allows chemotherapy seem to have higher survival rates. The generalization of endoscopic ultrasound-guided biliary drainage as an alternative to biliary percutaneous drainage could improve the survival rate in patients with failed ERCP.

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

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

Screening by fecal immunochemical test (FIT) reduces colon cancer (CC) mortality and incidence, yet its efficiency may vary depending upon tumor location and recipient demographics. We addressed the modifications of left and right CC epidemiology following screening adoption.

Aims & Methods

To address the differences between left and right CC, we analyzed by Joinpoint, robust and logistic regression models the data of Parma County tumor registry, comprising 6697 incident cases above 50 years of age in the period 1994-2018 and recording screening adherence since the start in 2005.

Results

Adjusted standardized rates of left-CC declined significantly within screening age (50-69 years) (male annual percent changes [APC] -8.38; p<.001; female APC -13.1; p=.007), as well above it (male APC-4.97; p=.001; female APC -3.96; p=.003). The incidence of right-CC did not decline in screening age and increased above (male APC, 1.91%; p=0.001; female APC, 2.23%; p<0.001). Robust regression confirmed that left-CC decreased irrespectively of sex and age (all p<.001, but for elder males, p=.03), pointing to significant increase of right-CC across sexes and ages (all p£.006).
In multivariable regression models, as compared left-CC the risk of right-CC almost doubled in the 7^thdecade (Odds Ratio 1.89, 95%CI 1.43-2.44; p=.001), was higher for females (OR 1.40; 95%CI 1.27-1.54; p<.001) and after screening adoption (OR 1.44, 95%CI 1.27-1.54; p<.001).
In sex specific models, the probability of right-CC in females increased from 65 years of age (OR 1.80, 95%CI 1.18-2.75; p=.007) and in males from 75 years (OR 1.58, 95% CI 1.09-2.27; p=.015).
Due to the unequal distribution of right-CC, the rate of interval cancers over screen detected ones was significantly different between males (78/315; 25%) and females (93/200; 46.5%; p=.0004).
Independently from screening participation, right-CC in females brought an increased risk only of stage II (OR 1.43, 95%CI 1.06-1.92; p=.017) while in males it also enhanced the risks of stage III (OR 1.54, 95%CI 1.17-2.02; p=0.002), and IV (OR 1.47, 95%CI 1.06-2.03; p=.02) cancers.
At Cox modeling, right-CC carried a lower risk of death in females than in males (HR 0.77, 95%CI 0.67-0.89; p<.001), independently from tumor stage and screening status.

Conclusion

The screening reduced only the incidence of left-CC, while that of right-CC raised with aging, primarily and earlier in females. Right-CC progression in males carried a higher risk of death. Unimodal administration of FIT was followed by increasing burden of right-CC, advocating awareness on its specific development and progression by sex and age.

Introduction

The biliary tree has traditionally been considered sterile under normal conditions¹. Recent evidence has revealed rich microbial communities in the biliary tract of patients affected by biliary tract disorders, supposing that biliary microbiota could play a significant role in the development of several biliary diseases, namely gallstones, autoimmune cholangiopathies, and cancer^2,3.
However, while possible connections between gut micro-organisms and biliary diseases has been studied more extensively, to date few evidences are available on how the microbiological composition may change disease’s progression⁴.
Not least it is still unclear how the modification of Oddi’s sphincter function after endoscopic sphincterotomy performed during an endoscopic retrograde cholangiopancreatography (ERCP) may represent a favorable environment for ascending bacterial colonization^5,6.

Aims & Methods

We performed a prospective observational study aimed to evaluate the prevalence of biliary pathogens of the bile in various disorders and to identify a microbial fingerprint for each disease. 162 consecutive patients with native papilla undergoing to ERCP for any indication were prospectively enrolled from July 2022 to April 2023. One bile sampling was performed after bile duct cannulation, before contrast injection and sphincterotomy, while a second one was done at the end of the procedure. Pre procedural clinical data, bile cultures and clinical follow-up were collected and analyzed.

Results

Biliary culture was obtained in 100% of patients. 52% of bile cultures were positive for at least 1 bacterium. No differences were found in microbial community before and after sphincterotomy. Out of 78 patients with positive bile cultures, 46 (59%) had cholangitis, all of them were under antibiotic therapy. Patients treated with immunomodulant agents did not have an increased risk of positive bile cultures. Multidrug-resistant bacteria were detected in pre-sphincterotomy bile cultures in 9 (5%) patients, of which 7 were extended-spectrum beta-lactamase (ESBL),1 Methicillin-resistant Staphylococcus aureus (MRSA) and 1 Vancomycin-Resistant Enterococci (VRE). No significant correlations were found between the presence of multidrug-resistant bacteria and underlying diseases, systemic cholangitis or immunomodulant exposure.

Conclusion

Our preliminary results showed how the biliary tree in patients with biliary diseases may not be sterile, even when Oddi’ s sphincter is intact. The presence of neoplastic diseases or immunosuppression therapy does not seem to correlate with an increase in positive bile cultures nor in multidrug resistant bacteria. Further analysis may be needed to assess the correlation between bile cultures and long-term outcomes.

References

1. Nicoletti, A. et al. Biliary tract microbiota: A new kid on the block of liver diseases? Eur. Rev. Med. Pharmacol. Sci. 24, 2750–2775 (2020).
2. Pereira, P., Aho, V., Arola, J., Boyd, S. & Jokelainen, K. Bile microbiota in primary sclerosing cholangitis : Impact on disease progression and development of biliary dysplasia. 1–15 (2017).
3. Chen, B., Fu, S. W., Lu, L. & Zhao, H. A preliminary study of biliary microbiota in patients with bile duct stones or distal cholangiocarcinoma. Biomed Res. Int. 2019, (2019).
4. Verdier, J., Luedde, T. & Sellge, G. Biliary Mucosal Barrier and Microbiome. Visz. Gastrointest. Med. Surg. 31, 156–161 (2015).
5. Ye, F. et al. Influence of the Biliary System on Biliary Bacteria Revealed by Bacterial Communities of the Human Biliary and Upper Digestive Tracts. 1–12 (2016). doi:10.1371/journal.pone.0150519
6. Schneider, J. et al. Risk factors for increased antimicrobial resistance : a retrospective analysis of 309 acute cholangitis episodes. 519–525 (2014). doi:10.1093/jac/dkt373

Disclosure

Cecilia Binda: Lecturer for Steris, Fujifilm, Q3 Medical, Boston Scientific
Chiara Coluccio: Lecturer for Steris
Carlo Fabbri: Lecturer for Steris, Q3 Medical, Boston Scientific

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.