Introduction

We conducted a multicenter, randomized, comparative study (MARVELOUS trial) of EPLBD without additional EST (EPLBD alone) versus EST at 19 institutions in Japan and reported the usefulness and safety of EPLBD alone for removing large common bile duct stones (Kogure H, et al. Endoscopy 2020; 52: 736-744). Long-term follow-up was conducted after stone treatment, and in this study, we compared the long-term outcomes of EPLBD alone and EST.

Aims & Methods

Of 161 patients who participated in the MARVELOUS trial and had complete stone removal (82 in the EPLBD alone group and 79 in the EST group), those who could be followed up for more than 30 days were included in the study. Long-term biliary events (recurrent bile duct stones, acalculous cholangitis, cholecystitis, and biliary tract cancer) in the EPLBD alone and EST groups were compared.

Results

The analysis included 59 cases in the EPLBD alone group and 62 cases in the EST group. There were no differences in background factors (age, sex, number and size of stones, diameter of the common bile duct, gallbladder status, and presence of periampullary diverticulum) between the two groups, except for age (77.8 vs. 81.7 years, P=0.01). The median follow-up periods were 44.4 months in the EPLBD alone group and 35.1 months in the EST group, and there were no significant differences in the incidence of long-term biliary events (15.3% vs. 22.6%). There were no significant differences in the incidence of recurrent bile duct stones (8.5% vs. 12.9%), acalculous cholangitis (5.1% vs. 3.2%), cholecystitis (5.1% vs. 12.5%), and biliary tract cancer (0% vs. 1.6%) between the two groups. Although the cumulative recurrence rates of stones (1/3/5 years) were 3.8%/8.3%/8.3% in the EPLBD alone group and 5.4%/18.3%/18.3% in the EST group, and the cumulative incidence rates of long-term biliary events (1/3/5 years) were 7.6%/12.1%/18.8% in the EPLBD alone group and 13.7%/24.6%/27.6% in the EST group, there was no statistically significant difference. No significant factors related to recurrent bile duct stones were extracted by univariate and multivariate analyses.

Conclusion

EPLBD without EST tends to have better long-term outcomes than EST and may be an option for the treatment of large bile duct stones.

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) techniques have advanced exponentially in recent years. However, ERCP is often challenging to complete, and one factor is the difficulty of the selective approach to the bile ducts, including the cystic duct, biliary stenosis, or postoperative anastomosis. We newly developed and commercialized a wire-driven bidirectional steerable catheter using artificial blood vessel material for ERCP, including these difficult cases. In this study, we evaluated its usefulness and safety in approaching the biliary tract using a desktop phantom in patients with surgically altered anatomy of Roux-en-Y hepaticojejunostomy.

Aims & Methods

The developed novel catheter uses a seamless tube that comprises a body part with polytetrafluoroethylene (PTFE) and a 15mm long distal part with porous expanded PTFE. The minimum tube diameter is 2.1 mm, and the distal tip diameter is 1.4 mm. Two loop-formed control wires are installed into the tube for bidirectional bending. A desktop experiment compared the bending performance via a balloon-assist enteroscopy and the trackability with a conventional catheter with a steerable tip. In addition, we clinically evaluated the success rate and duration of selective cannulation for the biliary branch and the frequency of complications in the four patients who underwent intestinal tract reconstruction by Roux-en-Y cholangiojejunostomy and required endoscopic treatment for symptoms such as acute cholangitis.

Results

The developed steerable catheter could bend over 90 degrees in both directions, and the minimum bending radius was about 4 mm, approximately five times smaller than the conventional steerable catheter. The desktop phantom trackability tests showed that using the developed steerable catheter and a guidewire enabled physicians to select bile duct branches with complex and steep angles easily and quickly. In the clinical evaluation, the insertion of the guide wire and the developed steerable catheter was swiftly completed in the bile ducts bilaterally in the patients, which was impossible with the conventional steerable catheter. The mean time required for guide wire insertion in the unilateral bile duct was 18.8 ± 10.1 seconds with the steerable catheter and 94.1± 42.1 seconds with the conventional catheter (p < 0.05). No catheter-related complications occurred.

Conclusion

The newly developed catheter with a steerable tip showed high bending performance compared to the conventional catheter. It was applied to complex diversion of the biliary branch for ERCP, especially in patients with surgically altered anatomy.

Introduction

Endoscopic retrograde cholangiopancreatography (ERCP) with endoscopic sphincterotomy (EST) is an established endoscopic treatment for common bile duct stones and acute cholangitis. Due to its less invasiveness compared to surgery, it has been accepted as a first choice even for the elderly receiving anticoagulants. However, there is only a limited number of reports of the safety of EST after minimal cessation of anticoagulant based upon the Japan Gastroenterological Endoscopy Society (JGES)guideline.

Aims & Methods

To evaluate the safety, we aimed to clarify the bleeding risk in patients taking anticoagulants in our institute. Patients who underwent ERCP at double institutes from January 2018 to December 2021. Among them, we compared the rate of bleeding after EST and bleeding requiring blood transfusion in anticoagulant patients and non-administrators. Patients taking anticoagulants were allowed to discontinue the direct oral anticoagulant (DOAC) on the day before or the day of ERCP, and those who followed the JGES guideline for warfarin were included.

Results

ERCP was performed in 1616 patients and an analysis of a total of 882 patients of EST including 69 patients taking anticoagulants revealed that there were no significant differences in the bleeding rate although the blood transfusion rate was significantly higher in the DOAC group (2/52 3.9%) and antiplatelet drug combination cases (1/15 6.7%) compared to other cases (5/805 0.6%). Univariate and multivariate analyzes were performed according to background age, sex, hypertension, diabetes mellitus, heart disease, cerebrovascular disease, hemodialysis, platelet count decreased (less than 10x10⁴/μL), and urgency (within 24 hours after consultation). In the univariate analysis for EST bleeding, cerebrovascular disease, hemodialysis, and thrombocytopenia were significant risk factors(p<0.05). As a result of the multivariate analysis of these, only cerebrovascular disease was a significant risk factor (OR=2.11, 95%CI: 1.21-3.68, p=0.0086). In the univariate analysis for blood transfusion, DOAC users, cerebrovascular disease, and hemodialysis patients were significant risk factors(p<0.05). A multivariate analysis that added EST bleeding to these results also found significant risk factors for similar items. DOAC(OR=6.89, 95%CI: 1.06-44.65, p=0.043) and cerebrovascular disease(OR=18.85, 95%CI: 3.01-117.93, p=0.0017), hemodialysis(OR=55.68, 95%CI: 6.51-475.99, p=0.00024) were significant risk factors for severe bleeding requiring blood transfusion.

Conclusion

Although there were no significant differences between the bleeding rates of EST for those taking anticoagulants and those not taking anticoagulants, it was suggested that there is a possibility of serious bleeding requiring blood transfusion in patients receiving anticoagulants, especially DOAC.

Disclosure

none

Introduction

The ulcers after duodenal endoscopic resection (ER) are exposed to bile and pancreatic juice, therefore delayed perforation and bleeding are common. As a preventive measure, the suture of the ulcer after ER has been reported to be effective. Our data are shown as follows. From January 2007 to January 2018, ER was performed for 219 duodenal tumors. We compared 211 lesions in the suture group with 8 lesions in the non-suture group. Delayed perforation was 0% in the suture group and 13% (1/8) in the non-suture group, showing a significant difference (p=0.0365). Delayed bleeding was 1% (3/211) in the suture group and 25% (2/8) in the non-suture group, showing a significant difference (p=0.01). Therefore, the suture of the ulcer after ER is essential. If the ulcer is small after ER, it can be sutured endoscopically, but if it exceeds 3 cm, it is difficult to suture with the endoscope alone.

Aims & Methods

The aim of this study is to investigate the outcome of duodenal laparoscopic and endoscopic co-operative surgery (D-LECS) for superficial non-ampullary duodenal epithelial tumors (SNADETs).
First, tissue around duodenum is dissected laparoscopically. Second, endoscopic submucosal dissection (ESD) is performed using saline injection, Hook knife, and VIO 300D or VIO3. Sites with poor maneuverability endoscopically were resected with laparoscopic assistance. Third, ulcer after ER is sutured laparoscopically. If inadequate, endo clip is added.
Thirty-five patients with SNADETs who underwent D-LECS from January 2014 to March 2023 were investigated outcome of procedure. The patient’s characteristics were as follows. male/female: 23/12, median age 65 (37-83) years old, location of the tumor (bulbs/2^nd/3rd portion): 3/27/5, major macroscopic type (0-I/0-IIa/0-IIc): 1/29/5. pancreatic side/ non-pancreatic side of duodenum: 26/9.
SM1 was defined as submucosal invasion of less than 500 μm, and SM2 was defined as deeper. R0 was defined as lateral and vertical margin negative, and lymph-vascular involvement negative. Median follow-up period was 13 (0-42) months.

Results

1. Median procedure time was 351 (195-673) minutes. In it, median endoscopic procedure time and laparoscopic procedure time were 205(132-429) and 131(67-420) minutes, respectively. Median diameter of resected specimen and tumor were 40 (26-70) and 27 (14-53) mm, respectively. Intramucosal tumor (Vienna classification category 3 to 5.1) /T1bSM2 (category 5.2): 31/4. The median length of hospital stay was 9 (8-15) days.
2. The en bloc resection and R0 resection rate were 94% (33/35), 83% (29/35), respectively.
3. Complications: intraoperative perforation was 8% (3/35). The intraoperative perforation site was sutured laparoscopically after ESD was completed. Intraoperative bleeding requiring blood transfusion, delayed perforation, and delayed bleeding were 0%.
4. The rate of complete closure by laparoscopy was 0% (0/26) for pancreatic side, and all of them were sutured with endo-clips and polyglycolic acid sheets. And that for non-pancreatic side was 100% (9/9).
5. Prognosis
Two cases of T1bSM2 were underwent pancreaticoduodenectomy, and there were no residual tumor and no lymph node metastasis. There has been no recurrence during twenty-eight and forty-two months after DLECS,
T1aM and T1bSM1 were followed up, and no local or metastatic recurrence was observed.

Conclusion

DLECS enabled complete closure of ulcers after ER regardless of size or location. Therefore, it is a safe and effective treatment for large SNADETs.