Introduction

Fecal microbiota transplantation (FMT) has been successfully used in a series of diseases in recent years. Most studies have focused on short-term risks, which are mild and generally associated with delivery methods. There have been no reports of FMT safety in the treatment of multiple diseases and long follow-up periods.

Aims & Methods

We performed a retrospective analysis of 11025 patients who underwent FMT in the Tenth People’s Hospital of Tongji University between January 2012 and December 2023. We included patients with various gastrointestinal diseases and patients with extraintestinal diseases that involved intestinal dysfunction. A questionnaire was administered to the included patients during follow-up (2 weeks, 3 months, 1 year, and 5 years after FMT) via telephone and health portal software Haodaifu app).

Results

Most adverse events during short-term follow-up (2 weeks) were related to the method of delivery. The main adverse events in the nasogastric tube group were tube-related respiratory difficulty (40.6%,include sore throat 14.1%, nasal congestion 8.7%, nasal irritation due to nasogastric intubation 17.8%) and nausea/vomiting (12.6%). In the oral capsules group, nausea and vomiting (8.9%) occurred during oral administration because the capsules are associated with a fecal smell and taste, both of which are difficult to remove completely. For colonoscopy and enema routes, the main adverse events were diarrhea (10.7%, 9.9%) and perianal discomfort (15.3%, 8.4%), respectively. Two cases in the colonoscopy group and one case in the enema group were complicated with colon perforation, but remission with conservative treatment. The most frequently reported adverse events were mild or moderate in severity and transient. Those symptoms associated with nasogastric tube administration disappeared after tube removal at the completion of treatment. Several other new symptoms were reported during short-term follow-up, although none occurred in >1% of patients. The most common symptom reported was bloating/flatulence. Although more adverse events were reported in the nasogastric tube group, most were mild. Additionally, patients are more comfortable with the upper gastrointestinal route because they could use it for enteral nutrition support or gastrointestinal imaging according to their medical needs. Based on our clinical experience, we proposed the “Tongji FMT Requirements”and implemented them in our clinic (beginning in 2019) to standardize the indications and timing of FMT treatment and to improve FMT safety. After the implementation of these requirements for 2 years, we compared safety data collected before and after implementation; The application of the requirements has effectively reduced adverse events. The short-term (mainly FMT-related diseases) incidence rate significantly decreased from 32.6% in 2017–2019 to 17.2% in 2019–2021.

Table 1.Tongji FMT Requirements

Conclusion

FMT appears safe during both short-term and long-term follow-up. The patient group that received FMT did not exhibit an increased incidence of new diseases, and the risk of infection transmission appears to be low. Considering the widespread use of FMT, there is a need for the establishment of a national clinical and patient-reported FMT safety collection system in future.

References

• 1) Kelly CR, Yen EF, Grinspan AM, et al. Fecal microbiota transplantation is highly effective in real-world practice: initial results from the fmt national registry. Gastroenterology 2021;160:183-192
• 2) Mullish BH, Quraishi MN, Segal JP, et al. The use of faecal microbiota transplant as treatment for recurrent or refractory clostridium diffificile infection and other potential indications: Joint british society of gastroenterology (BSG) and healthcare infection society (HIS) guidelines. Gut 2018;67:1920e41
• 3) Saha S, Mara K, Pardi DS, et al. Long-term Safety of Fecal Microbiota Transplantation for Recurrent Clostridioides difficile Infection. Gastroenterology 2021;160:1961-1969
• 4) Zhang S, Chen Q, Kelly CR, et al. Donor Screening for Fecal Microbiota Transplantation in China: Evaluation of 8483 Candidates. Gastroenterology 2022;162:966-968
• 5) Parenteral and Enteral Nutrition Branch of Chinese Medical Association, et al. Chinese experts consensus on standardized methodology and clinical application of fecal microbiota transplantation. Zhonghua Wei Chang Wai Ke Za Zhi 2020;23:5-13
• 6) Wang S, Kou C, Liu Y, et al. Rural-urban differences in the prevalence of chronic disease in northeast China. Asia Pac J Public Health 2015;27:394-406

Introduction

Renal disorders are among the extra-intestinal manifestations of inflammatory bowel disease (IBD), and treatments may also lead to renal failure. However, the incidence of end-stage renal disease (ESRD), defined as the need for renal replacement therapy (dialysis and/or renal transplantation (RT)), is poorly known. The primary objective of our study was to assess the incidence of ESRD in IBD patients, and to compare it with the general health insurance scheme population.

Aims & Methods

We conducted a prognostic cohort study based on data from the French National Health Insurance Database(SNDS). Prevalent cases of IBD affiliated to the general health insurance scheme during the period 2011-2020 were identified on the basis of declarations long-term diseases ALD 24 or the presence of 2 hospital stays for IBD with ICD-10 codes or a single stay with reimbursement of specific treatments. Incident cases of ESRD were identified on the basis of a stay with a RT or a period with dialysis sessions for at least 45 days. Crude incidence rates of ESRD were calculated over the period for the IBD and the non-IBD population, with their 95% confidence intervals.

Results

A total of 280,283 IBD patients were included in the study over the period 2011-2020, 134,567 with ulcerative colitis(UC) and 145,716 with Crohn’s disease(CD). The mean age at study inclusion was 39.8 (± 17.1) years. The M/F sex ratio was 0.9. The mean age at incidence of ESRD in the non-IBD population was 65.0 (±17.0) years, the M/F sex ratio cases was 1.7.
Among IBD patients, 534 patients began replacement therapy by dialysis or RT, they were younger than non-IBD patients (60.3(±16.7)years, P<0.001).The mean incidence rate of ESRD over the period was 26.4 per 100,000 person-years (IC95% 23.1-29.6), 480 (89.9%) patients entered ESRD by dialysis, and 54 (10.1%) by preemptive RT. In the non-IBD population the mean rate of ESRD was 15.9 per 100,000 person-years (IC95% 14.8- 17.1; P<0.0001 compared with IBD): 79,606 (94.5%) patients entered ESRD by dialysis, and 4,634 (5.5%) by RT (as compared with IBD,P<0.001). In subgroup analysis, the mean incidence rate of ESRD was 22.8 per 100,000 person-years (IC95% 18.9-26.7) in UC patients and 29.5 (IC95% 25.3-33.6) in CD patients (P<0,0001). The rates of preemptive RT were 12.4% in UC patients (87.6% dialysis) and 8.6% in CD patients (91.4% dialysis).
Over a median follow-up of 6.8 years, the survival rate after ESRD was 40.8% in ESRD-IBD patients VS 34.2% in ESRD non-IBD patients (P<0.001). This difference remained significant for patients under 65 (p<0.0073).
No significant difference for the risk of re-hospitalization after RT (p=0.84), of retransplantation during the follow-up period in RT patients (p=0.67), or for the risk of hospitalization for severe infection (p=0.97) after RT in patients from the general population compared with IBD patients. The same was true for the type of severe infections after RT (p= 0.068) and for the risk of solid and haematological cancer after RT (p=0.48). However, there was a significant difference in the type of first severe infection after RT(p=0.003), but we are waiting for the results to tell us which one.

Conclusion

The incidence of ESRD is significantly higher in IBD than in the general data base population, confirming the need for regular monitoring of renal function in our patients.
Survival after ESRD onset, is higher in IBD patients.
The high incidence of RT in the IBD population confirms that access to transplantation is not restricted in this
population.

References

Kirchgesner et al, Gastroenterology 2018
Meyer et al, Aliment Pharmacol Ther. 2020
Tuppin et al, Nephrol Ther 2016

Introduction

MACE is a new, non-invasive technology which approaches the diagnostic sensitivity of OGD in gastric focal lesion detection in patients with dyspepsia. [Li et al., CGH 2016] This study compared the two in the detection of focal and diffuse lesions in patients referred for the investigation of anaemia.

Aims & Methods

MACE was performed within one week before OGD using the AnX Robotica magnet system and Navicam capsule (single camera capsule, frame rate 6/sec: Wuhan, China). Following a fast, simethicone and gastric distension using 0.5-1L water, patients swallowed the capsule semi-recumbent on the left lateral side before lying supine to allow approximation of the magnet to the chest. The examination protocol included a sequence of magnet movements and patient position changes. Inspection of an anatomical location was considered complete if sufficient to exclude any significant pathology. Endoscopists performing OGD were blinded to the MACE outcome and all findings were recorded from a pre-identified diagnostic list. Data was analysed using SPSS.

Results

45 of 81 (55.5%; median age 63 (IQR 45.5- 72), 60% male) patients had pathology identified by MACE, OGD or both. Complete views were obtained by MACE in the oesophagus (72.4%), proximal stomach (93.8%), distal stomach (93.8%) and duodenum(79.6%, p<0.001) and mean examination time was 22 minutes. Findings were concordant in 17 (37.8%: gastric erosions (n=6), ulcers (n=5), oesophagitis (n=2), eroded polyps (n=2) and gastric antral vascular ectasia (n=2)). MACE alone identified pathology in 24 (53.3%: gastric erosions (n=17), angioectasia (n=4), ulcers (n=2, oesophageal and duodenal), eroded polyp (n=1) and both angioectasia and erosions (n=1). OGD identified a distal body ulcer (n=1), small (n=1) and large (n=1) oesophageal varices and oesophageal ulcers (n=1) missed by MACE and in one patient MACE identified only an oesophageal ulcer and OGD only a duodenal ulcer, each missing the pathology detected by the other. Diagnostic yield was higher for MACE than OGD (P<0.001).

Conclusion

The improved diagnostic yield of MACE compared to OGD is accounted for mainly by minor mucosal abnormalities which could, nonetheless, contribute to occult bleeding and anaemia. Although speculative this could be because of better tolerance of MACE and a longer examination time. An increased frame capture rate, with or without a second camera, is needed to improve oesophageal visualisation.

Disclosure

I herwith declare that the magnetic capsules for the study were provided by Ankon

Introduction

Various endoscopic closure procedures including over-the-scope systems and endoscopic hand suturing have been tested in preventing delayed bleeding after endoscopic resection1). Conventional procedures are technically difficult with long procedure time1), which partially explains its limited application in clinical practice. The novel through-the-scope (TTS) helix and tack suture system has been reported with high success rates and acceptable procedure time using in vivo porcine models along with clinical experience2,3). However, past reports have not identified the proficiency rate of the TTS suture system.

Aims & Methods

The objective of this study is to determine the number of cases needed in achieving closure time of literature-based mean closure time. One beginner with less than 400 experiences of upper gastrointestinal endoscopy and one expert with clinical experience of over 500 endoscopic submucosal dissections participated in this study. Both endoscopists were familiarized with the functionality and troubleshooting of the novel TTS suture system via educational videos. Four in vivo porcine models were used to create 24 mucosal defects with diameter of 2-4 cm in the stomach. Each endoscopist were randomly allocated 12 mucosal defects to close with one set of TTS suture system per procedure. The TTS suture system engages four 5 mm helical tacks tethered to a suture thread into the defect margin and approximates the mucosal defect by applying suture tension with a cinch. The primary outcome was the number of procedures required to achieve closure procedure time below the literature-based mean closure time (7.7 minutes) by inverse curve fitting with nonlinear regression. The secondary outcomes were the success rate of complete closure and the incidence of adverse events. Complete closure was defined as over 90% closure of defect in endoscopy image assessed by two certified endoscopy technicians.

Results

Mean (±SD) size of the mucosal defects was 2.9 (±0.2) cm. Both endoscopists required six cases to achieve a closure time of less than 7.7 minutes. The median closure time was 8.2 (IQR: 5.6-10.1) minutes for the expert and 8.0 (IQR: 6.3-9.4) minutes for the beginner (P = 0.8624). The success rates of complete closure were 75.0% (9/12) for the expert and 83.3% (10/12) for the beginner. Neither endoscopist experienced any adverse events.

Conclusion

The novel TTS suture system requires a small number of cases for both expert and beginner to achieve proficiency in endoscopic closure.

References

1) Kobara H, et al. Dig Endosc. 2023;35(2):216-31.
2) Hernandez A, et al. Endosc Int Open. 2021;09:E572-7.
3) Farha J, et al. Endoscopy. Published online: 12 Jan 2023; doi:10.1055/a-1970-5528.

Introduction

Patients with IBD often have related anxiety and depression which may negatively impact disease activity and have been consistently highlighted as an unmet need by patient groups. Timely access to psychiatric and psychological support can be difficult and costly. We investigated the effectiveness of a novel cognitive behavioural therapy (CBT) program delivered by a trained mental health nurse in place of a formal psychologist.

Aims & Methods

A retrospective review of all CBT referrals made for adult patents between Sep 2019 – Dec 2022 in a tertiary IBD Centre. Referrals were from IBD Consultants, senior medical Trainees, IBD Nurses and a liaison psychiatrist. Patients are offered high-intensity CBT for up to 8 consecutive weeks as per local protocol of a minimum 4 sessions. The CBT took place virtually; over the phone or video call via MS Teams. Patients who completed at least 4 sessions of CBT were included in this review.
Our primary measure was to assess if there was an improvement in mental health using CORE-10, a brief validated psychometric questionnaire, completed at the start and end of therapy. A score of greater than 11 was an indicator of psychological distress, and a reduction of 6 points is clinically meaningful[i].

Results

96 patients were referred to the inflammatory bowel disease CBT service. Of those 47 patients went on to complete at least 4 sessions of CBT, with an average age of 33. 91% of referrals were for either anxiety or depression. With other cited indications including; anger management, PTSD and functional pain.
15 patients (32%) had UC, 31 patients (66%) had Crohn’s disease and 1 patient had indeterminate colitis. The majority of patients had 8 sessions of CBT of which all were completed virtually. The average disease duration was least 8 years at the time of referral.
26 (55%) of patients were on biologics at the time of initiating CBT, with 23% patient of patients referred having undergone at least one surgery prior to referral. Physician global assessment at the initiation of CBT showed 25 (56%) patients were in clinical remission. 21 (45%) patients were in clinical remission following their course of CBT.
Following the completed CBT sessions 37 patients had some improvement in their CORE-10 score with a mean reduction for all patients of 7.6. 20 patients had a CORE-10 reduction of at least 6. 33 patients (70%) had a CORE10 score of >11 at baseline, indicating significant psychological distress. Of the 33 patients with an initial score >11, 20 patients 61% showed reliable clinical improvement.
10 patients (21%) referred for CBT showed, either an increase (8 patients) or no change (2 patients) in their CORE10 score following at least 4 sessions of CBT.

Conclusion

Studies have consistently demonstrated a high burden of anxiety amongst patients with IBD which can have a detrimental effect on quality of life and disease outcomes. CBT delivered by a trained mental health nurse is an effective and relatively low-cost intervention for patients with IBD, delivering beneficial treatment outcomes, and maintaining good levels of engagement; including those with a severe phenotype of disease.
CBT did not significantly influence disease activity as measured by physician global assessment.

References

[i] Barkham, M., Bewick, B., Mullin, T., Gilbody, S., Connell, J., Cahill, J., Mellor-Clark, J., Richards, D., Unsworth, G. and Evans, C. (2013b). The CORE-10: A short measure of psychological distress for routine use in the psychological therapies. Counselling and Psychotherapy Research, 13(1), pp.3–13. doi:https://doi.org/10.1080/14733145.2012.729069.

Disclosure

nil

Introduction

Control of intraoperative bleeding is vital in endoscopic submucosal dissection (ESD) for gastric neoplasms. We developed an ESD method specialized for hemostasis (Spray-ESD) focusing on the Spray coagulation mode (VIO3; ERBE) with high voltage, easy spark control, and improved incision performance.

Aims & Methods

This study aimed to determine the efficacy of Spray-ESD for gastric neoplasms compared to conventional ESD (C-ESD).
An open-label, randomized, controlled trial was conducted from June 2021 to February 2022 at five centers in Japan, and patients with gastric neoplasms meeting the absolute indication for ESD were included in the study. (The clinical registration number is UMIN000034353) Patients were randomized 1:1 to Spray-ESD or C-ESD, and the outcomes of both groups were compared. ESD was performed with an electrosurgical knife: ProKnife. Hemostatic forceps: Hemostat-Y was used for soft coagulation when bleeding was difficult to control. The primary endpoint was the completion rate of ESD using the knife alone without hemostatic forceps. Secondary endpoints were the number and duration of hemostatic forceps use, ESD procedure time, radical cure, and safety.

Results

We analyzed 130 registered cases (Spray-ESD: 65 cases, C-ESD: 65 cases). The completion rate of ESD using the knife alone was significantly higher in Spray-ESD (83.1% vs. 13.8%, P<0.001). The number and duration of hemostatic forceps use were significantly lower in Spray-ESD (median: 1 vs. 3.5 times, P<0.001; 2.0 min vs. 5.5 min, P<0.001). ESD procedure time was not significantly different between the two groups (48.0 min vs. 56.0 min, P=0.11). Both groups had equally high resection rates (complete en bloc resection rate: 100% vs. 95.4%, P=0.24; curative resection rate: 90.8% vs. 87.7%, P=0.78), with a low adverse events rate. (3.1% [posterior bleeding in 2 cases] vs. 6.2% [intraoperative perforation in 1 case, posterior bleeding in 3 cases], P=0.68).

Conclusion

Spray-ESD has been shown to significantly reduce major bleeding requiring hemostats while maintaining a high en bloc resection rate; mastery of the Spray coagulation mode allows for safe ESD with reduced bleeding risk.

Introduction

Delayed bleeding (DB) is a possible adverse event following gastric endoscopic submucosal dissection (ESD). The Bleeding after ESD Trend from Japan (BEST-J) score was created as a risk prediction model for DB following gastric ESD, but is yet to be validated in non-Asiatic populations.

Aims & Methods

We aimed to apply and validate the BEST-J score on a European sample.
We have conducted a longitudinal study of all consecutive patients undergoing gastric ESD on a European Endoscopic Unit. DB was defined as a hemorrhage with clinical symptoms and confirmed by emergency endoscopy from the time of completion of ESD to 28 days after ESD.
BEST-J score (use of vitamin K antagonists +4, direct oral anticoagulants +4, aspirin or P2Y12R antagonists +2; withdrawing antithrombotic drugs -1; chronic kidney disease +3; multiple lesions +1; lesion ≥30mm +1; lesion in lower-third of the stomach +1) was calculated in each patient and confronted with the outcome (DB).

Results

Final sample included 161 patients, 102 (63.4%) male, with a mean age of 68±8 years. From these, 10 (6.2%) presented DB following ESD, with a median time to bleeding of 7 days (IQR 6.8).
According to BEST-J score, bleeding risk was low (0-1 points) in 111 (68.9%), intermediate (2 points) in 29 (18.0%), high (3-4 points) in 16 (9.9%) and very high (≥5 points) in 5 (3.1%) patients.
BEST-J score presented an excellent accuracy predicting DB in our sample, with an AUC=0.907 (95%CI=0.801-1.000; p<0.001). The optimal cut-off value to predict DB was a BEST-J score ≥3, which matches the cut-off value for high-risk of bleeding in the original investigation. This value had a sensitivity of 90% and specificity of 92%.

Conclusion

The BEST-J score still presents excellent accuracy in risk stratification for post-ESD bleeding in European individuals. Thus, this score may help to guide which patients benefit the most from prophylactic therapies following gastric ESD in this setting.