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.

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

Emergency surgery (ES) is associated with higher morbidity and mortality for acute left colonic malignant obstruction. Since the first application of self-expandable metallic stent (SEMS), the technique has been popularly applied as “bridge to surgery (BTS)”. The short-term clinical outcomes and long-term oncologic prognosis remain controversial.

Aims & Methods

This retrospective study aimed to compare the performance for managing acute left colonic malignant obstruction by ES or BTS. The medical records were collected from May 2015 to December 2019 in two tertiary hospitals in Eastern China. Patients were followed up after surgery every 6 months for 3 years and once a year afterwards. Clinical success was defined as resumption of intestinal function for 30 days without morbidity or mortality after surgical procedure. All demographics, intervention procedures and follow-up were analyzed for short-term and long-term outcomes. Risk factors for long-term survival were discussed as well.

Results

A total of 136 patients were eligible for the study, 67 in BTS group and 69 in ES group. No significant differences concerning demographics were found, including age, sex, body-mass index (BMI), symptoms, coexisting disorders, laboratory tests, preoperative radiotherapy or chemotherapy, previous history of abdominal surgery, cancer location, obstructive degree and TNM stage. Technical success of SEMS insertion was achieved in 64 patients (95.5%). The interval from SEMS placement to elective surgery was 16 days. Minor perforation was detected on 4 patients during the elective surgery, while no symptomatic complaint was recorded.
BTS group showed better short-term performance, including less intraoperative decompressive intervention (85.1% vs. 69.6%, p=0.045), more complete decompression (64.2% vs. 27.5%, p＜0.001), more primary anastomosis (65.7% vs. 17.4%, p＜0.001), less temporary and permanent stoma (34.3% vs. 82.6%, 13.4% vs. 58.7%, both p＜0.001), less intensive care unit requirement (10.4% vs. 27.5%, p=0.011), less intraoperative complications (3.0% vs. 13.0%, p=0.031) and reduced 30-day mortality (0 vs. 8.7%, p=0.028). Longer hospitalization was observed in the BTS group (21.7±13.3 days vs. 14.9±7.6 days, p＜0.001). Postoperative hospitalization and total cost were comparable between the two groups. No significant difference was observed about clinical success (73.1% vs. 63.8%, p=0.240), overall mortality (53.7% vs. 64.4%, p=0.247) or long-term survival (52.0 months vs. 35.0 months, p=0.121). TNM stage Ⅳ, permanent stoma and postoperative complication were the independent risk factors for long-term survival.

Table.1 Operation related characteristics

Conclusion

SEMS served as a safe and effective bridge to elective surgery for acute left colonic malignant obstruction, without adverse effect on long-term survival. It significantly improved short-term outcomes by reducing perioperative complication, 30-day mortality and stoma. More prospective studies are necessary for further evaluating the clinical values of SEMS, and weighing its benefits against potential complications.

References

1. Manfredi S, Sabbagh C, Vanbiervliet G, et al. Place of colorectal stents in therapeutic management of malignant large bowel obstructions. Endoscopy. 2014;46:546-552.
2. Frago R, Ramirez E, Millan M, et al. Current management of acute malignant large bowel obstruction: a systematic review. Am J Surg. 2014;207:127-138.
3. Arezzo A, Passera R, Lo Secco G, et al. Stent as bridge to surgery for left-sided malignant colonic obstruction reduces adverse events and stoma rate compared with emergency surgery: results of a systematic review and meta-analysis of randomized controlled trials. Gastrointest Endosc. 2017;86:416-426.
4. van Hooft JE, van Halsema EE, Vanbiervliet G, et al. Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Gastrointest Endosc. 2014;80:747-761 e741-775.
5. Pisano MA-O, Zorcolo L, Merli C, et al. 2017 WSES guidelines on colon and rectal cancer emergencies: obstruction and perforation. 2017.
6. Kawachi J, Kashiwagi H, Shimoyama R, et al. Comparison of efficacies of the self-expandable metallic stent versus transanal drainage tube and emergency surgery for malignant left-sided colon obstruction. Asian J Surg. 2018;41:498-505.

Introduction

Up to 30% of the under 18 years age group suffer from functional constipation with significant impact on health-related quality of life. In addition to lifestyle and dietary modifications, the currently available medication (e.g. polyethylene glycol, lactulose, stimulant laxatives) have low response rates, frequent side-effects, and non-sustained effects. Lubiprostone is an oral chloride channel-2 activator that stimulates gastrointestinal fluid secretion, softens stools, and facilitates bowel movements. It is approved in the United States for the treatment of chronic idiopathic constipation in adults. The evidence about the effectiveness and safety of lubiprostone in pediatric age group is still limited, representing a gap in clinical practice.

Aims & Methods

Aim: To evaluation of the effectiveness and safety of lubiprostone in children and adolescents with functional constipation.
Patients and Methods: In an open label, randomized, controlled trial, we included 277 patients in the age group 8-18 years diagnosed as functional constipation (FC). The diagnosis of FC was dependent on ROME IV criteria. After physical evaluation, patients were randomly (Simple randomization) assigned to one of 2 arms. First arm (n =137): patients received lubiprostone at doses of 24 mcg/day on divided doses or 24 mcg BID if weighing < 50 kg or ≥ 50 kg, respectively. Second arm (control, n = 140): patients received Bisacodyl, lactulose, or Sodium Picosulfate in appropriate doses. Treatment extended for 12 weeks followed by 4 weeks follow-up after treatment cessation (week 16). Evaluation during the study was done at baseline, weeks 2, 8, 12, and 16 of the study. The primary endpoint was spontaneous bowel movements (SBM) at week 12 and 16 compared to baseline. Improvement in the constipation was defined as increased SBM ≥ 1 SBM/week in frequency compared with baseline and maintaining ≥ 3 SBMs/week for at least 8 weeks (including the last 4 study weeks and the 4 weeks of follow-up). Safety assessment was done at clinic visits and by telephone as well as recording of patient-reported AEs.

Results

The two arms were matched as regards the mean ± SD of SBM at baseline (1.23 ± 0.37 motions/week for lubiprostone vs. 1.19 ± 0.28 motions/ week for control, P = 0.24). the primary endpoint was achieved in 128 (93.4%) patients of lubiprostone group, and in 48 (34.3%) patients of the control group (p < 0.001, ꭓ² = 105.42). In subgroup analysis, lubiprostone was superior to different laxatives in the control arm (p< 0.001, F = 95.6). At 12 weeks, the mean SMB in lubiprostone arm was (4.78 ± 0.99 motion/week) vs. (2.70 ± 1.04 /week) for control group (P <0.001). This difference was sustained for 4 weeks follow-up in lubiprostone group only. The overall side-effects occurred among 46% of lubiprostone group, and 48% in control group (p = 0.99). The most common adverse event in lubiprostone group were colicky abdominal pain (26%), and headache (14%), There was no life-threatening drug-related adverse events.

Conclusion

Lubiprostone is superior to conventional laxatives, and well tolerated treatment for functional constipation in pediatric and adolescent age groups.

References

van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroentero 2006;101:2401–9.
Hyams, J. S., Di Lorenzo, C., Saps, M., Shulman, R. J., Staiano, A., & van Tilburg, M. Childhood Functional Gastrointestinal Disorders: Child/Adolescent. Gastroenterology 2016; 150(6), 1456–1468.e2.
Levy EI, Lemmens R, Vandenplas Y, Devreker T. Functional constipation in children: challenges and solutions. Pediatric Health Med Ther. 2017 Mar 9;8:19-27. doi: 10.2147/PHMT.S110940.
Benninga, M. A., Hussain, S. Z., Sood, M. R., Nurko, S., Hyman, P., Clifford, R. A., et al. Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension. Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2022; 20(3), 602–610.e5.

Disclosure

Nothing to declare