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1.
Gut Liver ; 2024 Jun 05.
Article in English | MEDLINE | ID: mdl-38835325

ABSTRACT

Background/Aims: Studies on elective switching to the subcutaneous (SC) formulation of infliximab revealed comparable efficacy and safety and higher infliximab level than those exhibited by intravenous (IV) infliximab. However, no studies have reported on the effectiveness of SC switching in ulcerative colitis (UC) patients who experienced IV infliximab failure during maintenance treatment. Methods: This retrospective study included UC patients who had been switched to SC infliximab because of IV infliximab failure, between January 2021 and January 2023. Group A was defined as having clinically and biochemically active UC (secondary loss of response), and group B consisted of patients with stable symptoms but biochemically active UC. Results: Twenty-three patients met the inclusion criteria: 15 in group A and eight in group B. The serum infliximab levels significantly increased after SC switching in both groups. The electively switched group also exhibited increased infliximab levels after SC switching. Patients in group A showed improved partial Mayo score with a significant decrease in fecal calprotectin and C-reactive protein after switching. In group B, the fecal calprotectin level significantly decreased without clinical relapse after switching. A high proportion of patients (≥80%) in both groups achieved clinical and/or biochemical responses at the last follow-up. During the follow-up period, only two patients in group A discontinued SC infliximab, and only one complained of severe injection site reaction. Conclusions: In UC patients who experience IV infliximab failure during maintenance treatment, switching to SC infliximab may be a promising option because of better efficacy and safety.

2.
Article in English | MEDLINE | ID: mdl-38866064

ABSTRACT

BACKGROUND: The impact of continuing or stopping 5-aminosalicylates (5-ASA) after commencing anti-tumour necrosis factor (anti-TNF) therapy in patients with inflammatory bowel disease (IBD) remains unclear. AIMS: To compare the outcomes of patients with IBD who stopped or continued 5-ASA after starting anti-TNF therapy. METHODS: We analysed data from the Korean National Health Insurance claims database between 2007 and 2020. We compared the clinical outcomes of patients who stopped or continued 5-ASA within 90 days of anti-TNF initiation. The primary outcome was any adverse clinical event defined as a composite of new corticosteroid use, IBD-related hospitalisation, or intestinal surgery. RESULTS: Among 7442 patients included for analysis (4479 [60.2%] with Crohn's disease [CD] and 2963 [39.8%] with ulcerative colitis [UC]), 1037 (13.9%) discontinued 5-ASA within 90 days of starting anti-TNF therapy. During a median 4.3-year follow-up, discontinuation of 5-ASA was not associated with an increased risk of adverse clinical events (adjusted hazard ratio 1.01, 95% confidence interval 0.93-1.10). The cumulative incidence of each adverse clinical event and the composite outcome were not significantly different between groups (all, p > 0.05). Additionally, separate analyses in CD and UC cohorts revealed no differences in adverse clinical outcomes between the 5-ASA continuation and discontinuation groups. Subgroup analyses by presumed risk factors for disease relapse showed no significant differences in the risk of adverse events between groups. CONCLUSIONS: In this nationwide population-based study, discontinuing 5-ASA after starting anti-TNF therapy was not associated with an increased risk of adverse events in patients with IBD.

3.
Dig Endosc ; 2024 Jun 27.
Article in English | MEDLINE | ID: mdl-38934243

ABSTRACT

OBJECTIVES: There have been significant advances in the management of large (≥20 mm) laterally spreading tumors (LSTs) or nonpedunculated colorectal polyps; however, there is a lack of clear consensus on the management of these lesions with significant geographic variability especially between Eastern and Western paradigms. We aimed to provide an international consensus to better guide management and attempt to homogenize practices. METHODS: Two experts in interventional endoscopy spearheaded an evidence-based Delphi study on behalf of the World Endoscopy Organization Colorectal Cancer Screening Committee. A steering committee comprising six members devised 51 statements, and 43 experts from 18 countries on six continents participated in a three-round voting process. The Grading of Recommendations, Assessment, Development and Evaluations tool was used to assess evidence quality and recommendation strength. Consensus was defined as ≥80% agreement (strongly agree or agree) on a 5-point Likert scale. RESULTS: Forty-two statements reached consensus after three rounds of voting. Recommendations included: three statements on training and competency; 10 statements on preresection evaluation, including optical diagnosis, classification, and staging of LSTs; 14 statements on endoscopic resection indications and technique, including statements on en bloc and piecemeal resection decision-making; seven statements on postresection evaluation; and eight statements on postresection care. CONCLUSIONS: An international expert consensus based on the current available evidence has been developed to guide the evaluation, resection, and follow-up of LSTs. This may provide guiding principles for the global management of these lesions and standardize current practices.

4.
Article in English | MEDLINE | ID: mdl-38766682

ABSTRACT

BACKGROUND AND AIM: Reliable bowel preparation assessment is important in colonoscopy. However, current scoring systems are limited by laborious and time-consuming tasks and interobserver variability. We aimed to develop an artificial intelligence (AI) model to assess bowel cleanliness and evaluate its clinical applicability. METHODS: A still image-driven AI model to assess the Boston Bowel Preparation Scale (BBPS) was developed and validated using 2361 colonoscopy images. For evaluating real-world applicability, the model was validated using 113 10-s colonoscopy video clips and 30 full colonoscopy videos to identify "adequate (BBPS 2-3)" or "inadequate (BBPS 0-1)" preparation. The model was tested with an external dataset of 29 colonoscopy videos. The clinical applicability of the model was evaluated using 225 consecutive colonoscopies. Inter-rater variability was analyzed between the AI model and endoscopists. RESULTS: The AI model achieved an accuracy of 94.0% and an area under the receiver operating characteristic curve of 0.939 with the still images. Model testing with an external dataset showed an accuracy of 95.3%, an area under the receiver operating characteristic curve of 0.976, and a sensitivity of 100% for the detection of inadequate preparations. The clinical applicability study showed an overall agreement rate of 85.3% between endoscopists and the AI model, with Fleiss' kappa of 0.686. The agreement rate was lower for the right colon compared with the transverse and left colon, with Fleiss' kappa of 0.563, 0.575, and 0.789, respectively. CONCLUSIONS: The AI model demonstrated accurate bowel preparation assessment and substantial agreement with endoscopists. Further refinement of the AI model is warranted for effective monitoring of qualified colonoscopy in large-scale screening programs.

5.
Intest Res ; 22(2): 186-207, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38720467

ABSTRACT

BACKGROUND/AIMS: We investigated the clinical practice patterns of post-polypectomy colonoscopic surveillance among Korean endoscopists. METHODS: In a web-based survey conducted between September and November 2021, participants were asked about their preferred surveillance intervals and the patient age at which surveillance was discontinued. Adherence to the recent guidelines of the U.S. Multi-Society Task Force on Colorectal Cancer (USMSTF) was also analyzed. RESULTS: In total, 196 endoscopists completed the survey. The most preferred first surveillance intervals were: a 5-year interval after the removal of 1-2 tubular adenomas < 10 mm; a 3-year interval after the removal of 3-10 tubular adenomas < 10 mm, adenomas ≥ 10 mm, tubulovillous or villous adenomas, ≤ 20 hyperplastic polyps < 10 mm, 1-4 sessile serrated lesions (SSLs) < 10 mm, hyperplastic polyps or SSLs ≥ 10 mm, and traditional serrated adenomas; and a 1-year interval after the removal of adenomas with highgrade dysplasia, >10 adenomas, 5-10 SSLs, and SSLs with dysplasia. In piecemeal resections of large polyps ( > 20 mm), surveillance colonoscopy was mostly preferred after 1 year for adenomas and 6 months for SSLs. The mean USMSTF guideline adherence rate was 30.7%. The largest proportion of respondents (40.8%-55.1%) discontinued the surveillance at the patient age of 80-84 years. CONCLUSIONS: A significant discrepancy was observed between the preferred post-polypectomy surveillance intervals and recent international guidelines. Individualized measures are required to increase adherence to the guidelines.

6.
Diagnostics (Basel) ; 14(8)2024 Apr 22.
Article in English | MEDLINE | ID: mdl-38667499

ABSTRACT

Fecal calprotectin (FC) is commonly used to assess Crohn's disease (CD) activity. However, standardized cut-off values accounting for bowel resection history and disease location are lacking. In this study, we analyzed data from patients with CD who underwent magnetic resonance enterography, ileocolonoscopy, and FC measurements from January 2017 to December 2018. In 267 cases from 254 patients, the FC levels in the 'operated' patients were higher when the disease was active compared with those who were in the remission group (178 vs. 54.7 µg/g; p < 0.001), and similar findings were obtained for the 'non-operated' patients (449.5 vs. 40.95 µg/g; p < 0.001). The FC levels differed significantly according to the location of inflammation, with lower levels in the small bowel compared to those in the colon. The FC cut-off levels of 70.8 µg/g and 142.0 µg/g were considered optimal for predicting active disease for operated and non-operated patients, respectively. The corresponding FC cut-off levels of 70.8 µg/g and 65.0 µg/g were observed for patients with disease only in the small bowel. In conclusion, different FC cut-off values would be applicable to patients with CD based on their bowel resection history and disease location. Tight control with a lower FC target may benefit those with a history of bowel resection or small-bowel-only disease.

7.
Yonsei Med J ; 65(5): 276-282, 2024 May.
Article in English | MEDLINE | ID: mdl-38653566

ABSTRACT

PURPOSE: This study aimed to evaluate the safety of biologics and small molecules for the treatment of inflammatory bowel diseases (IBD) in patients receiving antirejection therapies after organ transplants. MATERIALS AND METHODS: We reviewed the medical records of patients with IBD who received organ transplants at the Asan Medical Center between January 1989 and December 2021. We compared the parameters of patients receiving biologics or small molecules to those of patients without those therapies. RESULTS: This study included a total of 53 patients (ulcerative colitis, 41; Crohn's disease, 6; and gastrointestinal Behçet's disease, 6). Among them, 15 patients were receiving biologics or small molecules and 38 were not. During a mean follow-up of 119 months, the proportion of patients experiencing severe infections was significantly higher in those treated with biologics or small molecules than in those not treated. However, other safety outcomes (e.g., malignancies, adverse events, including organizing pneumonia or hepatic failure, and death) were not different between the two groups. Kaplan-Meier curve analysis revealed no significant difference in the safety outcome rate related to the use of biologics or small molecules. During follow-up, eight patients underwent bowel resections for IBD. The rate of bowel resection was not different between the two groups. CONCLUSION: The use of biologics or small molecules for patients with IBD who received organ transplants did not show a significant difference in safety outcomes. However, the possibility of severe infections must be considered.


Subject(s)
Biological Products , Inflammatory Bowel Diseases , Humans , Male , Female , Adult , Middle Aged , Biological Products/therapeutic use , Biological Products/adverse effects , Inflammatory Bowel Diseases/drug therapy , Retrospective Studies , Organ Transplantation/adverse effects , Transplant Recipients , Aged , Young Adult
8.
Sci Rep ; 14(1): 4047, 2024 02 19.
Article in English | MEDLINE | ID: mdl-38374188

ABSTRACT

Somatostatin analogues have recently been used as therapeutic targets for metastatic or surgically unresectable gastroenteropancreatic (GEP) neuroendocrine tumors (NETs), and associated somatostatin receptor (SSTR) expression has been well demonstrated in most GEP NETs, with the exception of rectal NETs. SSTR2 immunohistochemical expressions were evaluated in 350 surgically or endoscopically resected rectal NETs and compared to clinicopathologic factors. SSTR2 expression was observed in 234 (66.9%) rectal NET cases and associated tumors with smaller size (p = 0.001), low pT classification (p = 0.030), low AJCC tumor stage (p = 0.012), and absence of chromogranin expression (p = 0.009). Patients with rectal NET and SSTR2 expression had significantly better overall survival than those without SSTR2 expression both by univariable (p = 0.006) and multivariable (p = 0.014) analyses. In summary, approximately two-thirds of rectal NETs expressed SSTR2. SSTR2 expression was significantly associated with favorable behavior and good overall survival in patients with rectal NETs. Furthermore, SSTR2 expression can be used as prognostic factors. When metastatic disease occurs, SSTR2 expression can be used a possible target for somatostatin analogues.


Subject(s)
Intestinal Neoplasms , Neuroendocrine Tumors , Pancreatic Neoplasms , Rectal Neoplasms , Stomach Neoplasms , Humans , Neuroendocrine Tumors/genetics , Neuroendocrine Tumors/pathology , Prognosis , Receptors, Somatostatin/genetics , Receptors, Somatostatin/metabolism , Rectal Neoplasms/genetics , Rectal Neoplasms/surgery , Rectal Neoplasms/drug therapy , Somatostatin/metabolism
9.
World J Gastrointest Oncol ; 16(1): 51-60, 2024 Jan 15.
Article in English | MEDLINE | ID: mdl-38292837

ABSTRACT

BACKGROUND: The incidence of colorectal cancer (CRC) and preinvasive CRC (e.g., early colon cancer and advanced adenoma) is gradually increasing in several countries. AIM: To evaluate the trend in incidence of CRC and preinvasive CRC according to the increase in the number of colonoscopies performed in Korea. METHODS: This retrospective cohort study enrolled Korean patients from 2002 to 2020 to evaluate the incidence of CRC and preinvasive CRC, and assess the numbers of diagnostic colonoscopies and colonoscopic polypectomies. Colonoscopy-related complications by age group were also determined. RESULTS: The incidence of CRC showed a rapid increase, then decreased after 2012 in the 50-75 year-age group. During the study period, the rate of incidence of preinvasive CRC increased at a similar level in patients under 50 and 50-75 years of age. Since 2009, the increase has been rapid, showing a pattern similar to the increase in colonoscopies. The rate of colonoscopic polypectomy in patients aged under 50 was similar to the rate in patients over 75 years of age after 2007. The rate of complications after colonoscopy and related deaths within 3 mo was high for those over 75 years of age. CONCLUSION: The diagnosis of preinvasive CRC increased with the increase in the number of colonoscopies performed. As the risk of colonoscopy-related hospitalization and death is high in the elderly, if early lesions at risk of developing CRC are diagnosed and treated under or at the age of 75, colonoscopy-related complications can be reduced for those aged 76 years or over.

10.
Surg Endosc ; 38(4): 1775-1783, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38278933

ABSTRACT

BACKGROUND: An anastomotic stricture after colorectal surgery is principally managed by endoscopic balloon dilation (EBD). Although this intervention is effective, however, subsequent procedures or surgical interventions are often required. This study aimed to assess the long-term outcomes of EBD for anastomotic stricture arising from colorectal cancer surgery. MATERIALS AND METHODS: We analyzed 173 patients who received curative surgery for colorectal cancer at our hospital between January 2000 and December 2022 and had undergone EBD to manage anastomotic stricture. The medical records of these cases were retrospectively reviewed to assess the outcomes and risk factors for restenosis and permanent stoma. RESULTS: Of the 173 study patients, 41 (23.7%) presented with restenosis with a median time to recurrence of 49 [37-150] days. The restenosis group was significantly younger (55.6 years versus 60.8 years), with a more prominent rectal location (80.5% versus 57.6%), a higher incidence of hand-sewn anastomosis (24.4% versus 5.3%), and a higher percentage of neoadjuvant radiotherapy (34.1% versus 5.3%, P < 0.001). Multivariable analysis indicated neoadjuvant radiotherapy (adjusted HR 2.48; 95% CI 1.03-5.95) and cerebral vascular disease (adjusted HR 6.97; 95% CI 2.15-22.54) as independent prognostic factors for restenosis. Fourteen patients (8.1%) required a permanent stoma due to treatment failure. All cases needing a permanent stoma were male (14 patients, 100%, P = 0.007) and this group had a higher rate of neoadjuvant radiotherapy, adjuvant chemotherapy, and hand-sewn anastomosis. CONCLUSION: Patients receiving neoadjuvant radiotherapy are most prone to restenosis after an EBD intervention to manage an anastomotic stricture. Neoadjuvant radiotherapy is also a strong risk factor for requiring a permanent stomas due to treatment failure.


Subject(s)
Colorectal Neoplasms , Colorectal Surgery , Humans , Male , Female , Constriction, Pathologic/etiology , Constriction, Pathologic/surgery , Retrospective Studies , Dilatation/methods , Anastomosis, Surgical/adverse effects , Colorectal Neoplasms/surgery , Colorectal Neoplasms/complications , Risk Factors , Treatment Outcome
11.
Korean J Intern Med ; 39(2): 238-247, 2024 Mar.
Article in English | MEDLINE | ID: mdl-38062724

ABSTRACT

BACKGROUND/AIMS: Small rectal neuroendocrine tumors (NETs) can be treated with modified endoscopic mucosal resection (EMR). However, an optimal EMR method remains to be established. We aimed to assess the non-inferiority of Tip-in EMR versus precut EMR (EMR-P) for treating rectal NETs. METHODS: This prospective, multicenter, randomized controlled trial enrolled patients with rectal NETs of < 10 mm in diameter. The patients were randomly assigned to EMR-P and Tip-in EMR groups in a 1:1 ratio. Primary outcome was margin-negative (R0) resection rate between the two methods, with a noninferiority margin of 10%. RESULTS: Seventy-five NETs in 73 patients, including 64 eligible lesions (32 lesions in each, EMR-P and Tip-in EMR groups), were evaluated. In a modified intention-to-treat analysis, R0 resection rates of the EMR-P and Tip-in EMR groups were 96.9% and 90.6%, respectively, which did not demonstrate non-inferiority (risk difference, -6.3 [95% confidence interval: -18.0 to 5.5]). Resection time in the EMR-P group was longer than that in the Tip-in EMR group (p < 0.001). One case of intraprocedural bleeding was reported in each group. CONCLUSION: We did not demonstrate the non-inferiority of Tip-in EMR compared to EMR-P for treating small rectal NETs. However, the R0 resection rates for both techniques were high enough for clinical application.


Subject(s)
Endoscopic Mucosal Resection , Neuroendocrine Tumors , Rectal Neoplasms , Humans , Endoscopic Mucosal Resection/adverse effects , Neuroendocrine Tumors/diagnostic imaging , Neuroendocrine Tumors/surgery , Neuroendocrine Tumors/pathology , Prospective Studies , Treatment Outcome , Intestinal Mucosa/diagnostic imaging , Intestinal Mucosa/surgery , Intestinal Mucosa/pathology , Retrospective Studies , Rectal Neoplasms/surgery , Rectal Neoplasms/pathology
12.
Sci Rep ; 13(1): 18303, 2023 10 25.
Article in English | MEDLINE | ID: mdl-37880332

ABSTRACT

Leg pain can be caused by both lumbar spinal disease and chronic venous disorder (CVD) of leg veins, but their clinical differences have not been thoroughly investigated. This study aimed to determine the incidence of CVD among patients visiting a spine center for leg pain. A total of 196 cases underwent ultrasound examination with a diagnosis rate were 85.7% (168 cases). CVD-diagnosed cases were divided into two groups based on the severity of lumbar spinal disease. The Clinical grades, symptom areas, and symptom types were compared. The differences in symptom improvements with vasoactive medication were also assessed. The most common symptom area was calf then the foot in CVD, while calf then thigh in lumbar spinal disease. Tingling-paresthesia was the most common symptom type for both, with pain and cramping similarly common in CVD and pain more common than cramping in lumbar spinal disease. Considering that the majority of CVD cases (78.6%) had minor cutaneous changes and almost half of cases (41.7%) had refluxes only in tributaries, significant differences in symptom improvement in CVD-dominant group suggested that early-stage venous reflux is a symptomatic disease and a possible cause of leg pain and other symptoms.


Subject(s)
Spinal Diseases , Vascular Diseases , Humans , Leg/blood supply , Pain/etiology , Vascular Diseases/complications , Veins , Chronic Disease , Spinal Diseases/complications
13.
J Gastroenterol Hepatol ; 38(12): 2090-2096, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37655723

ABSTRACT

BACKGROUND AND AIM: Low-volume bowel preparation solutions, including 1-L polyethylene glycol plus ascorbate (PEG-A), have been developed to improve tolerability. The oral sodium sulfate tablet (OST) is a new agent with simethicone as a preloaded component. We investigated the efficacy, safety, and tolerability of OST compared to 1-L PEG-A. METHODS: A single-center, prospective, controlled study was performed with randomization into the OST (group A) and 1-L PEG-A (group B) groups. Bowel preparation efficacy was assessed on the Boston Bowel Preparation Scale (BBPS) and Bubble Scale. Safety and tolerability were evaluated using a questionnaire and laboratory examination. RESULTS: Final analysis was performed on 171 patients (group A: 87, group B: 84). The proportion of bowel preparation success (BBPS ≥ 2 for each colonic segment) in group A was not inferior compared to group B (95.4% vs 96.4%, P = 0.736, 1-sided 97.5% lower confidence limit -7.0%). The adenoma detection rate was not different (59.6% vs 41.9%; P = 0.087). The bubble scale was better in group A (0.2 ± 0.9 vs 1.9 ± 1.7, P < 0.001). All adverse events were mild in both groups. Nausea was less frequent in group A (14.9% vs 38.1%, P = 0.001). Overall satisfaction was better in group A (8.1 ± 2.1 vs 6.4 ± 2.8, P < 0.001). No clinically significant laboratory abnormality developed in both groups. These findings were similarly shown in old patients ≥65 years. CONCLUSIONS: Both OST and 1-L PEG-A were efficacious, safe, and tolerable for bowel preparation of colonoscopy. The OST showed fewer bubbles and slightly better tolerability.


Subject(s)
Cathartics , Polyethylene Glycols , Humans , Polyethylene Glycols/adverse effects , Prospective Studies , Cathartics/adverse effects , Colon , Colonoscopy , Ascorbic Acid/adverse effects
14.
J Gastroenterol Hepatol ; 38(12): 2152-2159, 2023 Dec.
Article in English | MEDLINE | ID: mdl-37646418

ABSTRACT

BACKGROUND AND AIM: This study aimed to investigate the effect of stenting-related factors, including endoscopists' expertise, on clinical outcomes after bridge-to-surgery (BTS) stenting for obstructive colorectal cancer (CRC). METHODS: We analyzed BTS stenting-related factors, including stenting expertise and the interval between stenting and surgery, in 233 patients (63 [13] years, 137 male) who underwent BTS stenting for obstructive CRC. We evaluated the influence of these factors on post-BTS stenting clinical outcomes such as stent-related complications and cancer recurrence. RESULTS: The interval between stenting and surgery was ≤ 7 days in 79 patients (33.9%) and > 7 days in 154 patients (66.1%). BTS stenting was performed by endoscopists with ≤ 50, 51-100, and > 100 prior stenting experiences in 94, 43, and, 96 patients, respectively. The clinical success rate of BTS stenting was 93.1%. Stent-related and postoperative complications developed in 19 (8.2%) and 20 (8.6%) patients, respectively. Cancer recurrence occurred in 76 patients (32.6%). Short BTS interval of ≤ 7 days increased the risk of postoperative complications (odds ratio [OR], 2.61 [1.03-6.75]; P = 0.043). Endoscopists' stenting experience > 100 showed greater clinical success of stenting (OR, 5.50 [1.45-28.39]; P = 0.021) and fewer stent-related complications (OR, 0.26 [0.07-0.80]; P = 0.028) compared with stenting experience ≤ 50. BTS stenting-related factors did not affect long-term oncological outcomes. CONCLUSION: Greater expertise of endoscopists was associated with better short-term outcomes, including high stenting success rate and low rate of stent-related complications after BTS stenting for obstructive CRC. An interval of > 7 days between BTS stenting and surgery was required to decrease postoperative complications.


Subject(s)
Colorectal Neoplasms , Intestinal Obstruction , Humans , Male , Colorectal Neoplasms/surgery , Colorectal Neoplasms/complications , Neoplasm Recurrence, Local/complications , Stents/adverse effects , Postoperative Complications/epidemiology , Postoperative Complications/etiology , Intestinal Obstruction/etiology , Treatment Outcome , Retrospective Studies
15.
J Gastroenterol ; 58(11): 1114-1123, 2023 Nov.
Article in English | MEDLINE | ID: mdl-37542674

ABSTRACT

BACKGROUND AND AIMS: The use of conventional oral sulfate tablets (OSTs) has gained popularity; nonetheless, they may be not only inconvenient to swallow but also difficult to dissolve. A novel mini-OST has recently been developed to enhance compliance with conventional OST use. This study aimed to compare the efficacy, tolerability, and safety between mini-OST and conventional OST. METHODS: This was a prospective, randomized, investigator-blinded, multicenter, and non-inferior phase 3 trial conducted between September 2022 and December 2022. The efficacy, safety, and tolerability were compared between mini-OST and conventional OST. RESULTS: Exactly 83 patients were evaluated based on a full analysis set (FAS), whereas 82 patients were evaluated as a per-protocol set (PPS). With respect to the efficacy of preparation, successful and high-quality preparation was excellent in the mini-OST and conventional OST groups on both FAS and PPS analyses, without significant differences between the two groups. On the FAS analysis, the satisfaction and tolerability scores were high in both groups, without significant differences. The first bowel movement after taking the investigational product occurred 30 min earlier in the mini-OST group than in the OST group. Mild, moderate, and severe adverse events (AEs) were comparable between the two groups; however, any AEs were more common in the mini-OST group than in the conventional OST group overall. CONCLUSIONS: Compared with conventional OST, the novel mini-OST preparation showed similar efficacy, tolerability, and safety, including mild eight solicited AEs and moderate-to-severe AEs. Clinical trial registration NCT05670470.

16.
Clin Endosc ; 56(4): 423-432, 2023 Jul.
Article in English | MEDLINE | ID: mdl-37501624

ABSTRACT

Compared to endoscopic mucosal resection (EMR), colonoscopic endoscopic submucosal dissection (C-ESD) has the advantages of higher en bloc resection rates and lower recurrence rates of colorectal neoplasms. Therefore, C-ESD is considered an effective treatment method for laterally spread tumors and early colorectal cancer. However, C-ESD is technically more difficult and requires a longer procedure time than EMR. In addition to therapeutic efficacy and procedural difficulty, safety concerns should always be considered when performing C-ESD in clinical practice. Bleeding and perforation are the main adverse events associated with C-ESD and can occur during C-ESD or after the completion of the procedure. Most bleeding associated with C-ESD can be managed endoscopically, even if it occurs during or after the procedure. More recently, most perforations identified during C-ESD can also be managed endoscopically, unless the mural defect is too large to be sutured with endoscopic devices or the patient is hemodynamically unstable. Delayed perforations are quite rare, but they require surgical treatment more frequently than endoscopically identified intraprocedural perforations or radiologically identified immediate postprocedural perforations. Post-ESD coagulation syndrome is a relatively underestimated adverse event, which can mimic localized peritonitis from perforation. Here, we classify and characterize the complications associated with C-ESD and recommend management options for them.

17.
Neurogastroenterol Motil ; 35(9): e14630, 2023 09.
Article in English | MEDLINE | ID: mdl-37392417

ABSTRACT

BACKGROUND: In this prospective cohort study, we evaluated features of "adult-onset megacolon with focal hypoganglionosis." METHODS: We assessed the radiologic, endoscopic, and histopathologic phenotyping and treatment outcomes of 29 patients between 2017 and 2020. Data from community controls, consisting of 19,948 adults undergoing health screenings, were analyzed to identify risk factors. Experts reviewed clinical features and pathological specimens according to the London Classification for gastrointestinal neuromuscular pathology. KEY RESULTS: The median age of the patients with adult-onset megacolon with focal hypoganglionosis at symptom onset was 59 years (range, 32.0-74.9 years), with mean symptom onset only 1 year before diagnosis. All patients had focal stenotic regions with proximal bowel dilatation (mean diameter, 78.8 mm; 95% confidence interval [CI], 72-86). The comparison with community controls showed no obvious risk factors. Ten patients underwent surgery, and all exhibited significant hypoganglionosis: 5.4 myenteric ganglion cells/cm (interquartile range [IQR], 3.7-16.4) in the stenotic regions compared to 278 cells/cm (IQR, 190-338) in the proximal and 95 cells/cm (IQR, 45-213) in the distal colon. Hypoganglionosis was associated with CD3+ T cells along the myenteric plexus. Colectomy was associated with significant symptom improvement compared to medical treatment [change in the Global Bowel Satisfaction score, -5.4 points (surgery) vs. -0.3 points (medical treatment); p < 0.001]. CONCLUSIONS AND INFERENCES: Adult-onset megacolon with focal hypoganglionosis has distinct features characterized by hypoganglionosis due to inflammation. Bowel resection appears to benefit these patients.


Subject(s)
Megacolon , Humans , Adult , Middle Aged , Aged , Prospective Studies , Megacolon/pathology , Colon/pathology , Myenteric Plexus/pathology , Colectomy
18.
PLoS One ; 18(5): e0286189, 2023.
Article in English | MEDLINE | ID: mdl-37228164

ABSTRACT

Indocyanine green (ICG) has been used in clinical practice for more than 40 years and its safety and preferential accumulation in tumors has been reported for various tumor types, including colon cancer. However, reports on clinical assessments of ICG-based molecular endoscopy imaging for precancerous lesions are scarce. We determined visualization ability of ICG fluorescence endoscopy in colitis-associated colon cancer using 30 lesions from an azoxymethane/dextran sulfate sodium (AOM/DSS) mouse model and 16 colon cancer patient tissue-samples. With a total of 60 images (optical, fluorescence) obtained during endoscopy observation of mouse colon cancer, we used deep learning network to predict four classes (Normal, Dysplasia, Adenoma, and Carcinoma) of colorectal cancer development. ICG could detect 100% of carcinoma, 90% of adenoma, and 57% of dysplasia, with little background signal at 30 min after injection via real-time fluorescence endoscopy. Correlation analysis with immunohistochemistry revealed a positive correlation of ICG with inducible nitric oxide synthase (iNOS; r > 0.5). Increased expression of iNOS resulted in increased levels of cellular nitric oxide in cancer cells compared to that in normal cells, which was related to the inhibition of drug efflux via the ABCB1 transporter down-regulation resulting in delayed retention of intracellular ICG. With artificial intelligence training, the accuracy of image classification into four classes using data sets, such as fluorescence, optical, and fluorescence/optical images was assessed. Fluorescence images obtained the highest accuracy (AUC of 0.8125) than optical and fluorescence/optical images (AUC of 0.75 and 0.6667, respectively). These findings highlight the clinical feasibility of ICG as a detector of precancerous lesions in real-time fluorescence endoscopy with artificial intelligence training and suggest that the mechanism of ICG retention in cancer cells is related to intracellular nitric oxide concentration.


Subject(s)
Carcinoma , Colonic Neoplasms , Precancerous Conditions , Mice , Animals , Indocyanine Green , Artificial Intelligence , Nitric Oxide , Colonic Neoplasms/diagnostic imaging , Colonic Neoplasms/pathology , Precancerous Conditions/diagnostic imaging , Endoscopy, Gastrointestinal , Optical Imaging/methods
19.
Sci Rep ; 13(1): 2604, 2023 02 14.
Article in English | MEDLINE | ID: mdl-36788338

ABSTRACT

The clinical usefulness of repeat colonoscopic polypectomy in patients with numerous polyps has not been sufficiently determined. We aimed to analyze the clinical outcomes of colonoscopic polypectomy with surveillance colonoscopies in patients with ≥ 10 polyps. We reviewed the medical records of 152 patients who underwent polypectomy of ≥ 10 polyps at the baseline colonoscopy. We investigated polyp number, polyp size, polypectomy method, procedure time, and adverse events of the baseline colonoscopy. We also investigated the frequency and interval of surveillance colonoscopies and their findings. The mean number of polyps detected at the baseline colonoscopy was 20.0, of which 16.0 polyps were endoscopically resected. The mean size of the largest polyp was 13.4 mm. The mean procedure time was 54.9 min. Post-polypectomy bleeding occurred in 6 (3.9%) patients, all of whom were treated conservatively. No patients developed perforation. With an increasing number of surveillance colonoscopies, the number of detected polyps and the procedure time decreased. Surveillance colonoscopies identified colorectal cancer only in three patients (2.0%), all of which were mucosal cancers that could be curatively treated by polypectomy. Colonoscopic polypectomy with repeat surveillance colonoscopies is a clinically effective, efficient, and safe management option in patients with ≥ 10 polyps.


Subject(s)
Colonic Polyps , Colorectal Neoplasms , Humans , Colectomy , Colonic Polyps/surgery , Colonoscopy/methods , Colorectal Neoplasms/surgery , Intestinal Polyps
20.
Lasers Surg Med ; 55(4): 378-389, 2023 04.
Article in English | MEDLINE | ID: mdl-36802075

ABSTRACT

OBJECTIVES: High-contrast and high-resolution imaging techniques would enable real-time sensitive detection of the gastrointestinal lesions. This study aimed to investigate the feasibility of novel dual fluorescence imaging using moxifloxacin and proflavine in the detection of neoplastic lesions of the human gastrointestinal tract. METHODS: Patients with the colonic and gastric neoplastic lesions were prospectively enrolled. The lesions were biopsied with forceps or endoscopically resected. Dual fluorescence imaging was performed by using custom axially swept wide-field fluorescence microscopy after topical moxifloxacin and proflavine instillation. Imaging results were compared with both confocal imaging with cell labeling and conventional histological examination. RESULTS: Ten colonic samples (one normal mucosa, nine adenomas) from eight patients and six gastric samples (one normal mucosa, five adenomas) from four patients were evaluated. Dual fluorescence imaging visualized detail cellular structures. Regular glandular structures with polarized cell arrangement were observed in normal mucosa. Goblet cells were preserved in normal colonic mucosa. Irregular glandular structures with scanty cytoplasm and dispersed elongated nuclei were observed in adenomas. Goblet cells were scarce or lost in the colonic lesions. Similarity analysis between moxifloxacin and proflavine imaging showed relatively high correlation values in adenoma compared with those in normal mucosa. Dual fluorescence imaging showed good detection accuracies of 82.3% and 86.0% in the colonic and the gastric lesions, respectively. CONCLUSIONS: High-contrast and high-resolution dual fluorescence imaging was feasible for obtaining detail histopathological information in the gastrointestinal neoplastic lesions. Further studies are needed to develop dual fluorescence imaging as an in vivo real-time visual diagnostic method.


Subject(s)
Adenoma , Proflavine , Humans , Moxifloxacin , Prospective Studies , Feasibility Studies , Adenoma/pathology , Optical Imaging
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