Introduction

Vedolizumab Clinical Decision Support Tool (V-CDST) identifies Crohn's disease (CD) patients most likely to benefit from vedolizumab administration. Real world data are needed to assess whether V-CDST is drug specific or can be applicable for other biologic CD agents. Aim of this study is to evaluate ability of the 5-variable V-CDST (5V-CDST) and new modified 3-variable V-CDST (3V-CDST) to predict effectiveness of adalimumab (ADA) or ustekinumab (UST) treatment for bio-naive CD patients.

Aims & Methods

A single center, noninterventional retrospective cohort review study was performed on real-life data of adult bio-naive CD patients who were treated with adalimumab (160/80 mg SC at BL/W2, then 40 mg SC every 2 Ws) or ustekinumab (6 mg/kg IV at BL then 90mg SC every 12 Ws) for a minimum of 6 months. Routine clinical, biochemical (CRP, serum albumin, fecal calprotectin - FC), and endoscopic (Simple Endoscopic Score for Crohn's disease – SES-CD; Rutgeerts score) findings were assessed according to STRIDE-II recommendations.
Treatment effectiveness was defined as FC <250 mcg/g, and/or SES-CD ≤3/Rutgeerts score ≤i2b, and/or no need for steroids, treatment escalation, switching biologics, and CD-related surgery. 5V-CDST score >19/3V-CDST score >3 were associated with high probability of treatment response and 5V-CDST score ≤19/3V-CDST score ≤3 with low probability of treatment response. Participants’ characteristics were assessed using descriptive statistics. Normal distribution was assessed using Kolmogorov-Smirnov and Shapiro-Wilk tests. Categorical variables were analyzed using the Chi-square and Fisher exact test. Binary logistic regression was carried out in order to assess the predictive capacity of 5V-CDST/3V-CDST.

Results

Total of 69 patients (53.3% females; smokers 25%) were included; 48 received ADA (median age 31.5 years), and 21 received UST (median age 52 years). Poor discriminative and predictive performance for the both 5V-CDST and 3V-CDST was observed both in the ADA and UST treated patients; there was no statisticaly significant difference between 5V-CDST and biochemical remission (ADA p=1; UST p=0.6), 3V-CDST and biochemical remission (ADA p=1; UST p=0.08), 5V-CDST and steroid-free remission (ADA p=0.36; UST p=0.28), 3V-CDST and steroid-free remission (ADA p=0.7; UST p=1), 5V-CDST and endoscopic remission (ADA p=0.36; UST p=0.6), 3V-CDST and endoscopic remission (ADA p=0.7; UST p=1), 5V-CDST and combination of steroid-free + biochemical + endoscopic remission (ADA p=0.18; UST p=0.46), 3V-CDST and combination of steroid-free + biochemical + endoscopic remission (ADA p=0.6; UST p=0.3), 5V-CDST and treatment escalation (ADA p=0.75; UST p=1), 5V-CDST and switching biologics (ADA p=0.33; UST p=1), 3V-CDST and switching biologics (ADA p=0.3; UST p=1), and 5V-CDST and CD-related surgery (ADA p=0.5 vs UST p=1). 3V-CDST in ADA group can discriminate patients with high probability for CD-related surgery; patients with 3V-CDST ≤3 are 48 times more likely to undergo operation compared to those with higher 3V-CDST (p<0.01; OR: 48). Same performance was not detected in UST group (p=0.2)

Conclusion

Regarding our cohort the 5V-CDST and 3V-CDST do not have a predictive capacity to identify groups of bio-naive CD patients which could benefit from administration of ADA or UST.

Introduction

The implementation of colorectal cancer screening programmes has been associated with an increase in the incidence of malignant polyps removed endoscopically. In those without endoscopic cure criteria, surgery can be performed to improve oncological outcomes.

Aims & Methods

Evaluate factors associated with the presence of residual malignant disease in the surgical specimen after endoscopic removal of a malignant polyp without endoscopic cure.
Retrospective, cohort study including patients with a malignant polyp endoscopically removed without endoscopic cure, who underwent surgery. The absence of endoscopic cure was defined as positive vertical resection margins (< 1 mm), poorly differentiated grade, depth of submucosal invasion > 1 mm, presence of lymphatic or vascular invasion, or presence of tumour budding. Patients with a synchronous neoplastic lesion and those with a malignant polyp without complete endoscopic removal were excluded.

Results

Included 74 consecutive patients submitted to surgery after the endoscopic removal of a malignant polyp without endoscopic cure. Most patients were male (62.2%), with a mean age of 64 ± 10 years. Regarding the endoscopic mucosal resection (EMR), 45 polyps were removed in one fragment (60.8%) and the other 29 were submitted to piecemeal EMR (39.2%). In 15 cases, snare tip spray coagulation (STSC) was performed at the margins of mucosal defects after EMR, 6 in normal-appearing margins (8.1%) and 9 in margins suspected of residual adenomatous tissue (12.2%). Considering the post-operative outcomes, 7 patients required surgical re-intervention (9.5%), 1 was admitted in the intensive care unit (1.4%), 1 patient died (1.4%), and 2 patients required re-hospitalization in the following 6 months (2.7%).
The presence of residual malignant disease in the surgical specimen occurred in 9 patients (12.2%), 7 had intramural disease (9.5%) and 2 had nodal metastasis (2.7%). Patients with polyps with a flat component were 5 times more likely to have residual disease in the surgical specimen (p=0.043). The polyp size and its location in the right colon were not associated with the presence of residual disease in the surgical specimen (p=0.140 and p=0.654, respectively). Patients with polyps submitted to piecemeal EMR were 7 times more likely to have residual disease in the surgical specimen (p=0.024), with 2 patients with residual disease after EMR in one fragment (4.4%) and 7 patients with residual disease from the piecemeal EMR group (24.1%). Those in which STSC was performed were also more likely to have residual disease in the surgical specimen (p<0.001). No statistically significant differences were found between the presence of positive margins, lymphatic or vascular invasion or well or moderately differentiated histologic grade, and the presence of residual disease in the surgical specimen (p=1.000, p=0.675 and p=0.686, respectively). Tumour budding was described in 3 patients, none of which had residual disease in the surgical specimen.

Conclusion

A minority of patients had residual malignant disease in the surgical specimen, with a higher risk for those with polyps with a flat component or that were submitted to piecemeal EMR. In fact, with piecemeal EMR almost one quarter of patients had residual disease e less than 5% of those with EMR in one fragment had residual disease in the surgical specimen, highlighting the need for a careful evaluation of the polyp before endoscopic removal and the importance of removal in one fragment, in case of suspected submucosal invasion.

Introduction

The incidence of colorectal neuroendocrine tumors (NETs) has increased over the past decades with early detection during screening colonoscopy.^1,2 The C-NET STUDY is a Japanese multicenter prospective cohort study, in which patients with colorectal NETs were consecutively enrolled.³

Aims & Methods

The study aimed to evaluate the short-term outcomes of various methods of endoscopic resection for colorectal NETs. Among the C-NET STUDY registrants, patients with colorectal NETs who underwent endoscopic treatment as the initial therapy were included. Patients who received treatment at a previous institution before participating in this study, biopsy diagnosed but the resected lesion was not pathologically diagnosed as NET, and who had defective data were excluded. The study protocol stated that endoscopic treatment should be performed if the tumor size is <10 mm in depth from the mucosa to the submucosa, with no ulceration or depression on the surface. For lesions with no treatment consensus in various guidelines, treatment selection was determined by each physician according to their policy in clinical practice. With respect to endoscopic resection procedures, several techniques were available in clinical practice, including endoscopic mucosal resection with a ligation device (ESMR-L), endoscopic mucosal resection using a cap (EMR-C), and endoscopic submucosal dissection (ESD). The major outcome measurements were short-term treatment outcomes, including en bloc resection rate, complete resection (defined as en bloc resection with tumor-free margin (R0)) rate, need for hospitalization, and treatment-related complications based on treatment modalities. Clinicopathological risk factors of incomplete resection (R1/RX) was also examined.

Results

A total of 472 patients with 477 colorectal NETs received endoscopic treatment. Of these, 418 patients with 421 lesions, who met the eligibility criteria, were included in the analysis. The median patient age was 55 years, and 56.9% of the patients were male. The lower rectum was the most common site (88.6%), and lesions <10 mm accounted for 87% of the cases. Among all cases, en bloc resection and R0 resection were achieved in 421 (100%) and 398 (94.5%) lesions. A total of 267 (63.4%) patients required hospitalization for treatment, with a median hospital stay of 3 days. Endoscopic mucosal resection with a ligation device (ESMR-L, 56.5%) was the most common method, followed by endoscopic submucosal dissection (ESD, 31.4%) and endoscopic mucosal resection using a cap (EMR-C, 8.5%). R0 resection rates <10 mm were 95.5%, 94.8 %, and 94.3% for ESMR-L, ESD, and EMR-C, respectively. All the treatment-related complications observed in 16 (3.8%) patients were treated conservatively. There were no independent clinicopathological risk factors for R1/X resection.

Conclusion

ESMR-L, ESD, and EMR-C were equally effective and safe techniques for colorectal NETs with diameter <10 mm (UMIN000025215).

References

1. Kooyker AI, Verbeek WH, van den Berg JG, et al. Change in incidence, characteristics and management of colorectal neuroendocrine tumours in the Netherlands in the last decade. United European Gastroenterol J 2020;8:59-67.
2. Ito T, Igarashi H, Nakamura K, et al. Epidemiological trends of pancreatic and gastrointestinal neuroendocrine tumors in Japan: a nationwide survey analysis. J Gastroenterol 2015;50:58-64.
3. Sekiguchi M, Hotta K, Takeuchi Y, et al. Characteristics of colorectal neuroendocrine tumors in patients prospectively enrolled in a Japanese multicenter study: a first report from the C-NET STUDY. J Gastroenterol 2022; 57: 547-558.

Introduction

There are two approaches for neoadjuvant treatment in locally advanced rectal cancer: conventional radiotherapy (RT) with concomitant chemotherapy and hypofractionated RT. In the RAPIDO study, preoperative hypofractionated RT versus conventional chemo-radiotherapy was proven to be equally effective. In our country and in our center (approximately 90%) previously, the standard treatment was conventional RT, however due to the COVID 19 pandemic in 2020, an increase in the use of hypofractionated RT was observed, this because it was a more accessible therapy for patients due to visits. In our country, the results of hypofractionation therapy compared to a conventional one have not been explored, therefore we decided to compare the outcomes between these modalities.

Aims & Methods

To compare early radiotoxicity of conventional vs. hypofractionated RT.
Methods: Retrospective study conducted in a national reference cancer center at National Institute of Cancer (INCAN) at Mexico City, during the period of April 2020 to December 2020.

Results

We analyzed 61 patients with rectal adenocarcinoma. Locally advanced were 91.8% and metastatic 8.2%. By tumor location upper third 11.4%, middle third 16.4%, middle third 72.1%. Regarding treatment, 72.1% received hypofractionation (25Gy in 5 fractions) and 27.9% conventional (45-50.4 Gy in 25-28 fractions). Techniques used 93.4% 3DCRT, 4.9% IMRT and 1.6% VMAT. Regarding general toxicity, it was observed in 30 patients (68%) in the hypofractionated group and 11 patients (64%) in the conventional treatment group p=0.794. Type of radiotoxicity is described in table 1. We observed a greater radiation mucositis grade 3 in the hypofractionated group compared with standard therapy. The other types were similar with no statistical significance. Table 1.

Conclusion

We observed a considerable increase in the use of hypofractionation in which we did not observe proctitis and cystitis in relation to conventional treatment, however caution and special attention must be exercised in radiation mucositis. We can increase the use of hypofractionated treatment with almost similar radiotoxicities. Further prospective studies are required to confirm these findings.

References

Introduction

Endoscopic ultrasound-guided gallbladder drainage is usually reserved for high surgical risk patients. The procedure was usually performed under deep sedation to ensure the best tolerability for the patient and facilitate the endoscopist’s performance.
However, many of them showed a high-risk even for deep sedation.

Aims & Methods

Our aim was to evaluate the safety and efficacy of EUS-GBD under conscious sedation (CS).
All consecutive EUS-GBD under CS performed in our hospital were prospectively enrolled from January 2020 to December 2022.
Patient characteristics, type and dosage of anesthetic drug administered (Fentanyl (FNT), Pethidine (PTD) or Benzodiazepine (BZD)), size of lumen-apposing-metal-stent (LAMS), gallbladder (GB) access, technical success, clinical success, early and late adverse events (AEs) rate were evaluated. Safety was defined as AEs occurrence. The efficacy of EUS-GBD was expressed as technical and clinical success. We defined as “conscious sedation” a drug-induced depression of consciousness during which patients respond to verbal commands or react to touch. Breathing remains intact and no support is needed.

Results

A total of 49 patients (41.7% male, mean age 82,9±10 years-old) underwent EUS-GBD under in our Unit. Among all the 49 EUS-GBD in CS, 47 (95.9%) were indicated as treatment for acute cholecystitis in high-surgical-risk patients and 2 (4.1%) as rescue-strategy after ERCP fail.
In 45 (91.8%) EUS-GBD a 10x10mm LAMS was deployed, in 3 (6.2%) procedures a 15x10mm and in 1 (2%) an 8x8mm LAMS. GB was accessed from the duodenum in 68.8% of cases.
A combination of PTD+BZD was administered in 29 (59.2%) EUS-GBD, while 18 (36.7%) procedures were performed under FNT+BZD. Only 2 (4.1%) EUS-GBD were performed only under BZD.
Mean FNT, PTD, BZD dose were 50(±11.5) mcg, 38.4(±25.6) mg and 4(±1.5) mg, respectively.
Technical success of EUS-GBD under CS was 97.9%. In one procedure the distal flange of the LAMS did not open due to LAMS malfunction. The clinical success of EUS-GBD under CS was 97.9% since in one procedure there was not a decrease of inflammatory, cytolysis and cholestasis indices. Only in 1 (2%) EUS-GBD an early AE was reported. No late AEs were described.
The statistical analysis showed that the administration of a combination of fentanyl and benzodiazepine or a combination of pethidine and benzodiazepines or the administration of only benzodiazepines affected neither technical nor clinical success, nor AEs rate (Table 1).

Conclusion

EUS-GBD under CS was a safe procedure with a low AEs rate.
The administration of FNT+BZD, PTD+BZD or BZD alone did not affect procedure outcome.

Introduction

Though the burden of musculoskeletal injury(MSI) by long-term accumulation of endoscopy procedures is well known, there is little data on the techniques that can reduce or prevent MSI.

Aims & Methods

The purpose of this study is to develop a new method for MSI assessment in long-term endoscopy practitioners and to establish an individualized MSI restoration plan through the special 16-week intervention of Kinetic Ergonomics based on Movement Analysis(KEMA) program by physical therapists.
Fifteen volunteer endoscopists practicing more than 10 years from 4 tertiary medical centers, were evaluated by demographics, endoscopy burden, location and degree of pain, and endoscopy posture. A comprehensive functional evaluations of ergonomic position, posture, and MSI and load during endoscopy was made by the physical therapist and self-perception questionnaire for involved joints was also evaluated. Then personalized KEMA program (musculoskeletal function evaluation and customized exercise program based on ergonomics) was delivered for 16 weeks by physical therapists on a one to one basis. KEMA program included recommendations for individualized exercises, static and dynamic posture re-education during and between procedures, optimization of procedure suite set-up and pain education. The endoscopists were re-evaluated regarding their perception and adherence to ergonomics and subjective symptoms at the end of the program.

Results

Various ergonomic problems were found to varying degrees in all 15 long-term endoscopy practioners including ergonomic inefficiencies and suboptimal movement patterns. Among 12 areas evaluated, pain areas were most commonly found in the order of the low back, neck, shoulder, wrist, and thumb. In addition, cumulative endoscopy time and neck and thumb pain, cumulative number of endoscopy cases and neck, back, and hip pain scores, neck and shoulder pain, and wrist and elbow pain showed positive correlations with each other. After 16-weeks KEMA program, among these 5 main painful joints, the remaining 4 joints (80%) showed improvement in the intensity and frequency of pain, except for the shoulder. Before and after the program, the level of understanding of knowledge about ergonomics increased from an average of 28 points to 33.6 (5-point scale of 10 items), but unfortunately, ergonomic attitudes and performance did not show significant changes.

Conclusion

The evaluation of MSI based on kinetic ergonomics for endoscopists and customized exercise program helped to recognize one's own body condition and relieve pain and recovery of the MSI even with a relatively short-term management of 16 weeks. These ergonomic interventions used here could potentially contribute to career longevity, decreased burnout, reduce lost days of work and most importantly reduction in pain and fatigue among practitioners.