Introduction

There are no established treatments for esophageal anastomotic stricture refractory to endoscopic balloon dilation (EBD). Patients experience a reduced quality of life and suffer a financial burden after surgery until the strictures are relieved. New treatments for refractory anastomotic stricture are clearly needed. Local steroid injection is reported to improve the effects of EBD. In addition, EBD with local steroid injection is a current community standard treatment for patients with refractory anastomotic stricture after esophagectomy, although the effect is limited. A new endoscopic treatment for such strictures is radial incision and cutting (RIC), which improves strictures by cutting through scar tissue at the stricture site with an electrocautery knife and removing any fibrous tissue that may cause re-stricture. However, the evidence for its effectiveness is limited to retrospective studies and small case series.

Aims & Methods

The aim of this multicenter, randomized, open-label, phaseⅡ/Ⅲ trial was to investigate the safety and the superiority of RIC with steroid injection compared with EBD with steroid injection for patients with refractory anastomotic stricture after esophagectomy for thoracic esophageal cancer. This is the first randomized controlled trial in the world for patients with refractory esophageal anastomotic strictures. Patients with Dysphagia Score ≥2 (able to swallow only semisolid foods or liquids) who had strictures through which a conventional endoscope (diameter, 9.6–10.4 mm) did not pass despite three or more EBDs or bougienage dilations were eligible for this trial. The primary endpoint in the phase II part was proportion of hemorrhages, post-operative esophageal perforations, esophageal hemorrhages, pneumothorax, lung or mediastinum infections or other unexpected adverse events. Co-primary endpoints in the phase III part were re-stricture-free survival and number of dilations for 24 weeks after treatment. This study was registered with the Japan Registry of Clinical Trials jRCTs031180177.

Results

From May 2014 to March 2022, 130 patients were enrolled from 32 institutions participating Gastrointestinal Endoscopy Study Group of the Japan Clinical Oncology Group and 65 patients each were randomized to EBD arm and RIC arm. The median number of dilations before registration was five in each arm. Dysphagia Score represented grade 2 (able to swallow semisolid foods) in 104 (80.0%) patients, grade 3 (able to swallow liquids only) in 25 (19.2%) patients, and grade 4 (unable to swallow liquids) in 1 (0.8%) patient in whole of study. Grade 3/4 pre-defined adverse events occurred in 1 (1.5%) patient in each arm. Median re-stricture-free survival in EBD arm was 10.6 weeks (95% CI: 6.9-20.1 weeks) and 8.7 weeks (95% CI: 7.1-10.9 weeks) in RIC arm (hazard ratio 1.22, 90% CI 0.85-1.74, one-sided p=0.82). The median number of dilations for 24 weeks after initial treatment was once (IQR: 0-2) in EBD arm and twice (IQR: 0-4) in RIC arm (one-sided p=0.99). The proportion of patients with anastomotic diameter >10 mm at 8 weeks after treatment was 27.7% (95% CI: 17.3-40.2%) in EBD arm and 24.6% (95% CI: 14.8-36.9%) in RIC arm.

Conclusion

RIC with steroid injection was not superior to repeated EBD with steroid injection for refractory anastomotic stricture after esophagectomy. EBD combined with steroid injection remains the standard of care for refractory anastomotic stricture after esophagectomy.

Introduction

Endoscopic submucosal dissection (ESD) is one of the effective treatments for superficial non-ampullary duodenal epithelial tumors (SNADETs). To avoid postoperative perforation and bleeding, our hospital had introduced D-LECS with ESD for SNADETs. From 2021, D-LECS was divided into D-LECS with FTR, which is a full-thickness resection, and D-LECS with ESD, which is intended for post-ESD reinforcement (1). D-LECS with ESD is considered to be a therapeutic procedure that not only ensures safety but also contributes to the improvement of endoscopic skills.

Aims & Methods

The aim of this study is to evaluate the impact of D-LECS with ESD on the skill development of endoscopists. The subjects were 17 cases in which D-LECS was performed among 79cases diagnosed with SNADA by biopsy at our hospital between January 2000 and October 2023. 5 cases in which D-LECS with ESD was performed. The ESD assessment score was defined using a ladder chart based on muscle layer exposure, perforation, ESD time, and pathological examination results. The scoring for points each item is as follows. (Exposure of muscle layer none: 0, <3mm: 1pt, 3~10mm: 2pt, 10mm<: 3pt, Perforation of the muscle none: 0, <3mm: 1pt, 3~10mm: 5pt, 10mm<: 10pt, ESD time <60min.: 0pt, 60~120min.: 5pt, 120min.<: 10pt, Pathological examination result pR0: 0pt, cR0+pRX: 5pt, pR1:10pt) Images and videos were used in combination to evaluate the muscle layer.

Results

ESD assessment scores of cases undergoing D-LECS with ESD were presented. The state of exposure of the muscle layer had a median of 5 (1-7), a mean of 4.8, and a standard deviation (SD) of 2.3. The state of perforation of the muscle layer had a median of 0 (0-10), a mean of 2.6, and a SD of 4.3. The median ESD time was 170 minutes, the mean was 146 minutes (41-198). The state of pathological examination had a median of 0 (0-10), a mean of 2.0, and a SD of 4.5. The ESD assessment scores are presented as follows: (Exposure of muscle layer, Perforation of muscles layer, ESD, Pathological examination result). The results of each score are as shown on the right, Case1: (7, 0,10, 0), Case2: (5,10, 10, 0), Case3: (5, 0, 10, 0), Case4: (6, 3, 10, 10), Case5: (1, 0, 1, 0). Although the number of cases was small, the time required for ESD was shortened and the degree of perforation tended to improve with experience. 2 examples revealed some important points. Case 1: This case had many blood vessels, and the ST hood was needed because it is difficult to perform ESD. When the endoscope was extended, perforation occurred. Once the perforation was made, it was difficult to move the patient to other bed, so the muscle layer was sutured with OTSC, and a PGA sheet. Case 2: The endoscopic strategy and device were improved, and the lesion could be dissected within 1 hour. ESD was performed with Dual Knife J 1.5. Pulling the lesion with an S-O clip. The RDI function was used during hemostasis to avoid the burn effect on the muscle layer.

Conclusion

D-LECS with ESD will lead to improvements of duodenal ESD techniques. But to ensure safety, laparoscopic closure is preferable until reliable suturing via endoscope becomes possible.

References

(1) Souya Nunobe, Motonari Ri, Naoki Hiki et al: Safety and Feasibility of laparoscopic and endoscopic cooperative surgery for duodenal neoplasm: a retrospective multicenter study. Endoscopy 53: 1065-1068, 2021

Introduction

Acute severe colitis (ASC) is an important cause of morbidity and mortality in Ulcerative Colitis (UC), requiring hospitalisation and, frequently, colectomy. Intravenous corticosteroids (CS) remain the first-line medical treatment. Approximately 40% of episodes of ASC do not respond to this treatment and require rescue therapy with ciclosporin (CIC) or infliximab (IFX)¹. In the past decades, these treatments and protocol-driven management algorithms led to reduced mortality and colectomy rates. A simple clinical scoring system (the Admission Model for the Intensification of Therapy in Acute Severe Colitis (ADMIT-ASC))³, based on CRP, albumin, and the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score, was recently developed to predict the steroid response on admission.

Aims & Methods

We aimed to retrospectively assess the steroid non-response during admission with ASC and the usefulness of the new prognostic clinical index ADMIT-ASC at admission to predict steroid response in a Belgian tertiary center. All patients admitted with ASC between 1^st January 2015 and 1^st April 2023 were identified from our inflammatory bowel disease database at Erasme University Hospital. Inclusion criteria were ASC patients admitted at the hospital, standard treatment with at least 3 days of intravenous CS and endoscopy evaluation upon admission. ASC was defined according to modified Truelove and Witts’ criteria as ≥6 bloody stools/day with one or more markers of systemic disturbance (tachycardia >90 beats/min, temperature >37.8°C, haemoglobin <105 g/L or CRP >30 mg/L). Steroid non-response was defined as the need for medical rescue therapy (CIC of IFX) or colectomy during the admission. ADMIT-ASC index consists of four points: CRP ≥100 mg/L (1 point), albumin ≤25 g/L (1 point) and UCEIS score ≥4 (1 point) or ≥7 (2 points).

Results

Table I Admission Demographics data (n= 84)	Steroid response (n=49)	Steroid non-response (n=35)	P value
Median disease duration (years) (IQR)	3.6 (0.3-0.9)	2.1 (0.8-5.5)	0.5
Montreal Classification	E1 : 5/49 (10%) E2 : 20/49 (41%) E3 : 24/49 (49%)	E1 : 0/35 E2 : 12/35 (34%) E3 : 23/35 (66%)	0.084
5-ASA, n (%)	22 (45%)	10 (29%)	0.13
Methotrexate or thiopurine, n (%)	6 (12%)	9 (26%)	0.11
Infliximab, n (%)	4 (8.2%)	8 (23%)	0.058
Vedolizumab, n (%)	7 (14%)	5 (14%)	>0.9
Tofacitinib, n (%)	2 (4.1%)	2 (5.7%)	>0.9
Readmission, n (%)	12 (24%)	10 (29%)	0.7
5-ASA, 5-aminosalicylate P values from Wilcoxon rank-sum test or Fisher’s exact test.

Out of 127 patients admitted with UC and treated with intravenous CS during three days, 84 (45% male, median age of 31 years old) were included in the study. Admission demographics and clinical characteristics are described in Table 1.
For 17 patients (20%), the admission was their index presentation of UC. Response to CS was seen in 49 patients (58%). Thirty-three patients (39%) received medical rescue therapy (17/33 IFX and 16/33 CIC). Colectomy rate during admission was 13% after a median duration of 18 days (IQR: 16-54). Admission C reactive protein (CRP) (p=0.036), albumin (p=0.026) and UCEIS scores (p=0.022) were significantly associated with steroid non-response. Patients scoring 0, 1, 2, 3 and 4 had steroid response rates of 90%,75%, 55%, 19% and 0%, respectively. Scoring of ≥3 was 75% (95% CI, 0.43 to 0.95) predictive of steroid failure (OR 5.08, 95%, CI 1.38 to 24.5).

Conclusion

In this tertiary referral cohort study, we confirmed that the ADMIT-ASC index is a simple clinical tool that can be used on the day of admission to predict steroid non-response in ASC with a threshold of ≥3 to identify patients who are unlikely to respond to intravenous CS and enabling timely treatment escalation or surgery.

References

1. Travis S, Satsangi J, Lémann M. Predicting the need for colectomy in severe ulcerativecolitis: a critical appraisal of clinical parameters and currently available biomarkers. Gut 2011;60:3–9.
2. Travis SP, Farrant JM, Ricketts C, et al. Predicting outcome in severe ulcerative colitis.Gut 1996;38:905–10.
3. Adams A, Gupta V, Mohsen W, et al. Gut 2023;72:433–442.

Disclosure

VB has not disclosure.
CDT has not disclosure.
CM has not disclosure.
AC has received lecture fees from Galapagos, Abbvie, Janssen, celltrion, Pfizer, Takeda.
DF has received lecture fees from Abbvie, Astrazeneca, Dr.Falk Pharma, Ferring, Janssen, Mundipharma, MSD, Pfizer, Takeda, Amgen, and advisory board fees from Abbvie, Janssen,Takeda, Celltrion, Amgen.
CL has received consultancy fees from Janssen, Abbvie, Takeda and Galapago and speaker fees from Sandoz, Janssen, Abbvie

Introduction

Rigid surgical instruments used for conventional laparoscopic surgery provide limited movement, and it is difficult to perform skillful surgery due to their long, jointless straight features. Articulated instruments could have the same advantages seen in robotic surgery, such as excellent control in smaller spaces, restoration of more intuitive and ergonomic movements, and the ability to overcome obstacles on a direct visual line. The aim of this study was to evaluate the surgical performance and clinical outcomes of patients following laparoscopic colorectal surgery with multijoint laparoscopic instruments, ArtiSential® (LivsMed, Seongnam, Korea), compared with those using conventional instruments.

Aims & Methods

Patients aged 19–80 years undergoing elective laparoscopic surgery for colorectal disease between December 2021 and November 2022, were consecutively enrolled. The first 20 cases underwent conventional laparoscopic surgery, and the latter 50 cases underwent laparoscopic surgery using ArtiSential®. Unedited operative videos were submitted to the Crowd-Sourced Assessment of Technical Skills (C-SATS) platform for evaluation using the Global Operative Assessment of Laparoscopic Skills (GOALS), which is a validated tool for technical proficiency. Each of GOALS’ four domains (bimanual dexterity, depth perception, efficiency, and tissue handling) was scored on a Likert scale between 1 and 5, scoring anchor, with a total score ranging from 4 to 20. The learning curve analysis was performed using the cumulative sum control chart (CUSUM) for GOALS grades (Registration number: KCT0006798).

Results

There was no significant difference between group with regards to type of operation, hospital stay, and 30-day postoperative complication. The GOALS’ grades were similar between the two groups (15.7 ± 0.7 vs. 15.9 ± 0.5, P = 0.190), but the scores in two domains (depth perception and tissue handling) were significantly higher in the ArtiSential® group (3.9 ± 0.3 vs. 4.0 ± 0.2, P = 0.014 and 3.9 ± 0.2 vs. 4.1 ± 0.2, P = 0.048, respectively) compared with those in the conventional group. In addition, patients in the ArtiSential® group experienced a shorter operation time (122.3 ± 58.9 vs. 88.1 ± 35.1, P = 0.022) and less intraoperative blood loss (56.5 ± 69.9 vs. 29.8 ± 1.4, P = 0.002) than those in the conventional group. According to the CUSUM learning curve analysis, the first 10 cases using ArtiSential® were in the inexperienced phase, and the remaining 40 cases were in the experienced phase. The GOALS’ score in the experienced phase of ArtiSential® was improved compared with that in the conventional group (16.0 ± 0.5 vs. 15.7 ± 0.7, P = 0.037).

Conclusion

A plateau in the learning curve of laparoscopic colorectal surgery performed with an articulated instrument was observed in approximately 10 cases, and it can be expected that surgical proficiency in the experienced phase increases without deterioration of clinical outcome as compared to that in conventional surgery.

References

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Disclosure

This research was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea (grantnumber: HI20C2092).

Introduction

To evaluate the utility of the unroofing technique in the diagnosis of gastrointestinal subepithelial tumors (SETs), we performed a multicenter retrospective study.

Aims & Methods

This study was conducted in 10 hospitals and involved all eligible patients who underwent unroofing techniques to gain biopsy for gastrointestinal SETs between April 2015 and March 2021. The primary endpoint was the rate of correct diagnosis with the unroofing technique, and the secondary endpoints were the incidence of adverse events and the factors contributing to the correct diagnosis.

Results

The study included 61 patients with 61 gastrointestinal SETs, a median tumor size of 20 mm, and a median procedure time of 38 minutes with 82% successful tumor exposure. The rate of tissue acquisition was 98.4%, and the rate of pathological diagnosis was 72.1%. In 44 cases with a pathological diagnosis, two showed discrepancies with the postresection pathological diagnosis. No factors, including facility experience, organ, tumor size, or tumor exposure, significantly affected the correct diagnosis. No significant differences in the correct diagnosis rate were observed between less than ten experiences and more than ten experiences (74.1 vs. 70.6%). The correct diagnosis rates for tumors <20 mm and ≥20 mm were 76.9% and 65.7%, respectively. There was one case of delayed bleeding and two cases of perforations.

Conclusion

The diagnostic yield of the unroofing technique was acceptable. The unroofing technique was beneficial regardless of institutional experience, organ, tumor size, or actual tumor exposure.

Introduction

In the southwest Netherlands, hospitals collaborate to provide high quality, uniform care for inflammatory bowel disease (IBD). To achieve this, a care pathway (CP) was implemented for treating IBD with biologics and small molecules (1). The CP consists of protocols addressing different stages in IBD treatment, such as initiation and switching of therapy, frequency and type of follow-up. This study assessed the adherence to the CP and identified barriers and facilitators to its implementation.

Aims & Methods

A mixed-methods study was conducted. Quantitative data was used to evaluate the adherence to different protocols of the CP and was collected retrospectively from electronic health records (EHRs) from December 2020 until March 2023. Surveys and semi-structured interviews were used to identify barriers and facilitators, using the Extended Normalisation Theory. Surveys were sent to all healthcare providers and interviews were conducted with gastroenterologists, IBD-nurses, healthcare assistants, and IT-personnel.

Results

A total of 299 patients were included. Adherence to the CP regarding the documentation of travel plans and vaccination status improved after implementing the CP (15% pre-implementation vs. 33% post-implementation), as well as written communication with general practitioners (31% vs. 83%) and body weight registration (12% vs. 50%). Among patients switching medication, 25% had a repeated screening for HIV, tuberculosis, and hepatitis B and C documented if prior tests were over a year old. Post-implementation, scheduling outpatient visits were more closely aligned with CP recommendations across CP protocols (57% vs. 100%), as did blood test ordering (10% vs. 44%). Disease activity scoring with validated questionnaires remained low (7% vs. 21%).  Adherence to registering medication adherence, current smoking status, and side effects during annual outpatient visits remained low (18% vs. 40%).
Of 85 surveys, 42 were completed, and 11 interviews were conducted. Facilitators were improving collaboration between healthcare providers and the potential to standardise care. Barriers included the complexity of the use in EHRs, difficulty for healthcare providers to change their current routine, and the heterogeneity of IBD.

Conclusion

A CP for the treatment of IBD with biologics and small molecules has been implemented to improve IBD care, however, adherence appears to be challenging, partially contributed to the difficulty healthcare providers experience in changing their behaviour. The gradual improvement indicates that increased familiarity with the CP may enhance adoption. Discrepancies between performed and documented tasks in EHRs may also contribute to lower adherence rates, which could be improved by audit and feedback sessions.

References

1. van Linschoten R, van Leeuwen N, Nieboer D, Birnie E, Scherpenzeel M, Verweij KE, et al. Value-based care pathway for inflammatory bowel disease: a protocol for the multicentre longitudinal non-randomised parallel cluster IBD Value study with baseline period. (2044-6055 (Electronic))

Disclosure

Drs. Visser received speaker fees from Lilly outside the submitted work. Prof. Dr. van der Woude reports grants from Pfizer and Janssen and personal fees from AbbVie and Celltrion outside the submitted work. Dr. van Noord reports personal fees from Janssen, Takeda, and Falk outside the submitted work. Dr. West reports personal fees from AbbVie, Janssen, and Pfizer outside the submitted work.