Defining Endoscopic Remission in Crohn's Disease: MM-SES-CD and SES-CD Thresholds Associated With Low Risk of Disease Progression.

BACKGROUND & AIMS: We assessed Modified Multiplier Simple Endoscopic Score for Crohn's Disease (MM-SES-CD) and Simple Endoscopic Score for Crohn's Disease (SES-CD) thresholds that are best associated with low likelihood of long-term disease progression. METHODS: Data from 61 patients with early Crohn's disease (CD) who participated in the CALM long-term extension study were used as the derivation cohort and validated using the McMaster inflammatory bowel disease database (n = 99). The primary outcome was disease progression (new internal fistula/abscess, stricture, perianal fistula or abscess, CD-related hospitalization or surgery) since the end of the CALM trial. Optimal MM-SES-CD and SES-CD thresholds were determined using the maximum Youden index. Receiver operating characteristic curve analyses compared threshold scores of remission definitions on disease progression. RESULTS: In the derivation cohort, based on the maximum Youden index, the optimal thresholds associated with a low likelihood of disease progression were MM-SES-CD <22.5 and SES-CD <4. A significantly greater proportion of patients with a MM-SES-CD ≥22.5 had disease progression as compared with patients in the derivation cohort with MM-SES-CD <22.5 (10/17 [58.8%] vs 3/44 [6.8%]; P < .001). Similarly, a significantly greater number of patients with SES-CD ≥ 4 had disease progression compared with those with a SES-CD <4 (11/25 [44.0%] vs 2/36 [5.6%]; P < .001). Compared with other clinical or endoscopic remission definitions, which demonstrated poor to fair accuracy, MM-SES-CD <22.5 performed the best for predicting disease progression (area under the curve = 0.81; 95% confidence interval, 0.68-0.94; P < .001). These thresholds were confirmed in the validation cohort. CONCLUSION: Achievement of MM-SES-CD <22.5 or SES-CD <4 in patients with ileocolonic or colonic CD is associated with low risk of disease progression and may be suitable targets in clinical trials and practice for endoscopic healing.

Systematic Resection of the Visible Scar After Incomplete Endoscopic Resection of Rectal Neuroendocrine Tumors.

INTRODUCTION: When initial resection of rectal neuroendocrine tumors (r-NETs) is not R0, persistence of local residue could lead to disease recurrence. This study aimed to evaluate the interest of systematic resection of non-R0 r-NET scars. METHODS: Retrospective analysis of all the consecutive endoscopic revisions and resections of the scar after non-R0 resections of r-NETs. RESULTS: A total of 100 patients were included. Salvage endoscopic procedure using endoscopic submucosal dissection or endoscopic full-thickness resection showed an R0 rate of near 100%. Residual r-NET was found in 43% of cases. DISCUSSION: In case of non-R0 resected r-NET, systematic scar resection by endoscopic full-thickness resection or endoscopic submucosal dissection seems necessary.

Endoscopic submucosal dissection assisted by adaptive traction: results of the first 54 procedures.

BACKGROUND : Good submucosal exposure is key to successful endoscopic submucosal dissection (ESD) and can be achieved with various traction devices. Nevertheless, these devices have a fixed traction force that tends to decrease as the dissection progresses. In contrast, the ATRACT adaptive traction device increases traction during the procedure. METHODS : In this retrospective analysis of prospectively collected data (from a French database), we analyzed ESD procedures performed with the ATRACT device between April 2022 and October 2022. The device was used consecutively whenever possible. We collected details of lesion characteristics, procedural data, histologic outcomes, and clinical consequences for the patient. RESULTS : 54 resections performed in 52 patients by two experienced operators (46 procedures) and six novices (eight procedures) were analyzed. The ATRACT devices used were the ATRACT-2 (n = 21), the ATRACT 2 + 2 (n = 30), and the ATRACT-4 (n = 3). Four adverse events were observed: one perforation (1.9 %), which was closed endoscopically, and three delayed bleeding events (5.5 %). The R0 rate was 93 %, resulting in curative resection in 91 % of cases. CONCLUSION: ESD using the ATRACT device is safe and effective in the colon and rectum, but can also be used to assist with procedures in the upper gastrointestinal tract. It may be particularly useful in difficult locations.

Traction-assisted endoscopic submucosal dissection for resection of ileocecal valve neoplasia: a French retrospective multicenter case series.

BACKGROUND: The ileocecal valve (ICV) is considered to be one of the most difficult locations for endoscopic submucosal dissection (ESD). The objective of this study was to evaluate the efficacy and safety of traction-assisted ESD in this situation. METHODS: All patients who underwent traction-assisted ESD for an ICV lesion at three centers were identified from a prospective ESD database. En bloc and R0 rates were evaluated. Factors associated with non-R0 resection were explored. RESULTS: 106 patients with an ICV lesion were included. The median lesion size was 50 mm (interquartile range 38-60) and 58.5% (62/106) invaded the terminal ileum. The en bloc and R0 resection rates were 94.3% and 76.4%, respectively. Factors associated with non-R0 resection were lesions covering ≥75% of the ICV (odds ratio [OR] 0.21. 95%CI 0.06-0.76; P=0.02), and involving the anal lip (OR 0.36, 95%CI 0.13-0.99; P=0.04) or more than two sites on the ICV (OR 0.27, 95%CI 0.07-0.99; P=0.03). CONCLUSION: Traction-assisted ESD for treatment of ICV lesions was a safe and feasible option. Large lesions and anal lip involvement appeared to be factors predictive of difficulty.

The environmental impact of small-bowel capsule endoscopy.

INTRODUCTION: The environmental impact of endoscopy, including small-bowel capsule endoscopy (SBCE), is a topic of growing attention and concern. This study aimed to evaluate the greenhouse gas (GHG) emissions (kgCO2) generated by an SBCE procedure. METHODS: Life cycle assessment methodology (ISO 14040) was used to evaluate three brands of SBCE device and included emissions generated by patient travel, bowel preparation, capsule examination, and video recording. A survey of 87 physicians and 120 patients was conducted to obtain data on travel, activities undertaken during the procedure, and awareness of environmental impacts. RESULTS: The capsule itself (4 g) accounted for < 6 % of the total product weight. Packaging (43-119 g) accounted for 9 %-97 % of total weight, and included deactivation magnets (5 g [4 %-6 %]) and paper instructions (11-50 g [up to 40 %]). A full SBCE procedure generated approximately 20 kgCO2, with 0.04 kgCO2 (0.2 %) attributable to the capsule itself and 18 kgCO2 (94.7 %) generated by patient travel. Capsule retrieval using a dedicated device would add 0.98 kgCO2 to the carbon footprint. Capsule deconstruction revealed materials (e. g. neodymium) that are prohibited from environmental disposal; 76 % of patients were not aware of the illegal nature of capsule disposal via wastewater, and 63 % would have been willing to retrieve it. The carbon impact of data storage and capsule reading was negligible. CONCLUSION: The carbon footprint of SBCE is mainly determined by patient travel. The capsule device itself has a relatively low carbon footprint. Given that disposal of capsule components via wastewater is illegal, retrieval of the capsule is necessary but would likely be associated with an increase in device-related emissions.

Factors associated with decreased ovarian reserve in Crohn's disease: A systematic review and meta-analysis.

INTRODUCTION: It is still unclear whether Crohn's disease (CD) might be associated with diminished ovarian reserve (OvR) and factors influencing anti-Mullerian hormone (AMH) levels in CD are poorly known. MATERIAL AND METHODS: We conducted a comprehensive literature search of multiple electronic databases from inception to June 2022 to identify all studies reporting AMH levels or factors associated with diminished OvR in patients with CD. RESULTS: Of the 48 studies identified in our search, eight (including 418 patients with CD) were finally included. The mean difference (95% confidence interval [CI]) in the AMH level between pooled CD patients and controls was -0.56 (-1.14 to 0.03) (p = 0.06). A history of CD-related surgery was not associated with a lower OvR (odds ratio, OR [95% CI] 1.34, [0.66-2.7]; p = 0.4). While disease activity and perianal disease seems associated with a low OvR, disease location (L2 vs. L1, OR [95% CI] = 95% CI [0.47-7.4]; p = 0.4) and L3 vs. L1 (OR [95% CI] = 1.44 [0.67-3.12]; p = 0.3), CD medication, and disease behavior were not. CONCLUSIONS: Our systematic review and meta-analysis did not identify a significantly low OvR in patients with CD. Contrary to CD-related surgery risk factor, active disease was associated lower AMH levels.

Effectiveness of Switching From Intravenous to Subcutaneous Infliximab in Patients With Inflammatory Bowel Diseases: the REMSWITCH Study.

BACKGROUND AND AIMS: We assessed the effectiveness of switching from intravenous to subcutaneous infliximab in patients with inflammatory bowel diseases (IBDs) treated with or without intensified intravenous regimen. METHODS: In this multicenter observational study, IBD patients in clinical remission (partial Mayo score ≤2 or Harvey-Bradshaw index ≤4) were switched to a unique dose of subcutaneous infliximab (120 mg every other week). Pharmacological and biological data were collected at baseline, visit 1 (4-8 weeks postswitch), visit 2 (8-16 weeks postswitch), and visit 3 (16-24 weeks postswitch). Relapse was defined as clinical relapse or fecal calprotectin increase ≥150 µg/g compared with baseline. RESULTS: Among 184 eligible patients, 72.3% (n = 133 of 184) agreed to switch to subcutaneous infliximab. At visit 3, a relapse occurred in 10.2% (n = 6 of 59), 7.3% (n = 3 of 38), 16.7% (n = 3 of 18), and 66.7% (n = 10 of 15) (P < .001) of patients receiving 5 mg/kg every 8 weeks, 10 mg/kg every 8 weeks, 10 mg/kg every 6 weeks, and 10 mg/kg every 4 weeks, respectively. Dose escalation to 240 mg every other week led to recapture clinical remission in 93.3% (n = 14 of 15). Infliximab serum levels increased after the switch (P < .0001) except for patients receiving 10 mg/kg every 4 weeks. In multivariable analysis, 10 mg/kg every 4 weeks regimen (odds ratio, 12.4; 95% confidence interval, 1.6-98.4; P = .017) and fecal calprotectin >250 µg/g at baseline (odds ratio, 5.4; 95% confidence interval, 1.1-27.6; P = .042) had a higher risk of relapse as well as reduced (41.7%) or stable (36.8%) infliximab serum levels between baseline and visit 1 compared with increased serum levels (12.7%) (P = .020 and P = .019, respectively). Patients' acceptability (10-point scale) was improved by the switch (6.9 ± 1.6 vs 8.6 ± 1.4; P < .0001). No severe adverse event was reported. CONCLUSIONS: Switching from intravenous to subcutaneous infliximab 120 mg every other week is safe and well accepted, leading to a low risk of relapse in IBD patients except for those receiving 10 mg/kg every 4 weeks requiring 240 mg every other week.

Endoscopic submucosal dissection of appendicular lesions is feasible and safe: a retrospective multicenter study (with video).

BACKGROUND AND AIMS: Endoscopic submucosal dissection (ESD) is challenging for appendicular lesions. We report the outcomes of ESD in this context. METHODS: We collected data of ESD procedures for appendiceal neoplasia in a multicenter prospective registry. Main study endpoints were R0, en-bloc, and curative resection rates and adverse event rate. RESULTS: One hundred twelve patients were included, 47 (42%) with previous appendectomy. Fifty-six (50%) were Toyonaga type 3 lesions (15 [13.4%] postappendectomy). En-bloc and R0 resection rates were 86.6% and 80.4%, respectively, with no significant difference associated with different grades of appendiceal invasion (P = .9 and P = .4, respectively) or previous appendectomy (P = .3 for both). The curative resection rate was 78.6%. Additional surgery was performed in 16 cases (14.3%), including 10 (62.5%) Toyonaga type 3 lesions (P = .04). This included the treatment of 5 cases (4.5%) of delayed perforation and 1 acute appendicitis. CONCLUSIONS: ESD for appendicular lesions is a potentially safer and effective alternative to surgery for a significant proportion of patients.

Diagnostic endoscopic submucosal dissection for colorectal lesions with suspected deep invasion.

BACKGROUND: Endoscopic submucosal dissection (ESD) is potentially a curative treatment for T1 colorectal cancer under certain conditions. The aim of this study was to evaluate the feasibility and effectiveness of ESD for lesions with a suspicion of focal deep invasion. METHODS: In this retrospective multicenter study, consecutive patients with colorectal neoplasia displaying a focal (< 15 mm) deep invasive pattern (FDIP) that were treated by ESD were included. We excluded ulcerated lesions (Paris III), lesions with distant metastasis, and clearly advanced tumors (tumoral strictures). RESULTS: 124 patients benefited from 126 diagnostic dissection attempts for FDIP lesions. Dissection was feasible in 120/126 attempts (95.2 %) and, where possible, the en bloc and R0 resection rates were 95.8 % (115/120) and 76.7 % (92/120), respectively. Thirty-three resections (26.2 %) were for very low risk tumors, so considered curative, and 38 (30.2 %) were for low risk lesions. Noncurative R0 resections were for lesions with lymphatic or vascular invasion (LVI; n = 8), or significant budding (n = 9), and LVI + budding combination (n = 4). CONCLUSION: ESD is feasible and safe for colorectal lesions with an FDIP ≤ 15 mm. It was curative in 26.6 % of patients and could be a valid option for a further 30.6 % of patients with low risk T1 cancers, especially for frail patients with co-morbidities.

Use of endoscopic submucosal dissection or full-thickness resection device to treat residual colorectal neoplasia after endoscopic resection: a multicenter historical cohort study.

INTRODUCTION : Residual colorectal neoplasia (RCN) after previous endoscopic mucosal resection is a frequent challenge. Different management techniques are feasible including endoscopic full-thickness resection using the full-thickness resection device (FTRD) system and endoscopic submucosal dissection (ESD). We aimed to compare the efficacy and safety of these two techniques for the treatment of such lesions. METHODS : All consecutive patients with RCN treated either using the FTRD or by ESD were retrospectively included in this multicenter study. The primary outcome was the R0 resection rate, defined as an en bloc resection with histologically tumor-free lateral and deep margins. RESULTS : 275 patients (median age 70 years; 160 men) who underwent 177 ESD and 98 FTRD procedures for RCN were included. R0 resection was achieved in 83.3 % and 77.6 % for ESD and FTRD, respectively (P = 0.25). Lesions treated by ESD were however larger than those treated by FTRD (P < 0.001). The R0 rates for lesions of 20-30 mm were 83.9 % and 57.1 % in the ESD and FTRD groups, respectively, and for lesions of 30-40 mm were 93.6 % and 33.3 %, respectively. On multivariable analysis, ESD procedures were associated with statistically higher en bloc and R0 resection rates after adjustment for lesion size (P = 0.02 and P < 0.001, respectively). The adverse event rate was higher in the ESD group (16.3 % vs. 5.1 %), mostly owing to intraoperative perforations. CONCLUSION: ESD is effective in achieving R0 resection for RCN whatever the size and location of the lesions. When residual lesions are smaller than 20 mm, the FTRD is an effective alternative.

Endoscopic submucosal dissection combined with clip for closure of gastrointestinal fistulas including those refractory to previous therapy.

BACKGROUND: Gastrointestinal (GI) fistula is a life-threatening condition and a therapeutic challenge. Endoscopic approaches include mucosal abrasion, clip closure, or stent diversion, with moderate success rates in the long term. We assessed whether fistula endoscopic submucosal dissection with clip closure (FESDC) could lead to complete resolution of fistulas even after failure of previous endoscopic therapy. METHODS: Patients with GI fistulas, including those with previous failed treatment, were retrospectively included. The primary outcome was long-term (> 3 months) success of fistula healing. Secondary outcomes included technical success, safety, and factors associated with FESDC success. RESULTS: 23 patients (13 refractory 57 %) were included. Tight immediate sealing was achieved in 19 patients (83 %; 95 % confidence interval [CI] 61 %-95 %). Long-term closure was achieved in 14 patients (61 %; 95 %CI 39 %-80 %), with median follow-up of 20 months. Complications occurred in two patients (9 %). Previous local malignancy (P = 0.08) and radiotherapy (P = 0.047) were associated with a higher risk of failure. CONCLUSION: This novel FESDC strategy was demonstrated to be safe and feasible for permanent endoscopic closure of GI fistulas. Further studies are warranted to determine the place of this technique in the management of chronic GI fistula.

Endoscopic Treatment of Enterocutaneous Fistulas in Crohn's Disease.

BACKGROUND: Management of enterocutaneous fistulas in Crohn's disease is challenging. Most patients still need intestinal resection in the biologic era. OBJECTIVE: The aim of this study was to evaluate the efficacy of endoscopic treatment for enterocutaneous fistulas. DESIGN: This is a retrospective study of medical records. SETTINGS: This study was conducted in a single institution. PATIENTS: All consecutive patients with Crohn's disease with an enterocutaneous fistula who underwent endoscopic fistula closure with the use of an over-the-scope clip or a hemostatic clip were included. MAIN OUTCOME MEASURES: The main outcome measured was the clinical success 3 months after the procedure, which was defined as the complete closure of all fistulas at physical examination and complete cessation of the drainage from the external opening, without surgery. RESULTS: Eight patients (men, 25%; median age 45 years [interquartile range, 33-51]) were followed. Fistulas were localized at the ileocolonic or colocolonic anastomosis in 7 patients and at the stomach in 1 patient. Seven patients were treated with an over-the-scope clip, and one was treated with a hemostatic clip. Technical success was achieved in all cases. Clinical success at 3 months was achieved in 75% of cases (6/8 patients). After a median 16-month (interquartile range, 13-23) follow-up, 3 of 8 (37.5%) patients had enterocutaneous fistula closure and 2 of 8 (25%) needed intestinal resection. No complications were observed. LIMITATIONS: The retrospective nature, the small sample size of the study, and the heterogeneity of the population limit the interpretation of the results. CONCLUSIONS: Endoscopic treatment of enterocutaneous fistulas is feasible with a short-term effectiveness. Additional studies are needed to confirm these results. See Video Abstract at http://links.lww.com/DCR/B614. TRATAMIENTO ENDOSCPICO DE FSTULAS ENTEROCUTNEAS EN ENFERMEDAD DE CROHN: ANTECEDENTES:Es desafiante el manejo de las fístulas enterocutáneas en enfermedad de Crohn. En la era biológica, la mayoría de los pacientes todavía requieren de resección intestinal.OBJETIVO:Evaluar la eficacia por tratamiento endoscópico de fístulas enterocutáneas.ENTORNO CLINICO:Estudio retrospectivo de registros médicos.AJUSTE:Realizado en una sola institución.PACIENTES:Se incluyeron todos los pacientes consecutivos con fístula enterocutánea en enfermedad de Crohn, sometidos a cierre endoscópico de la fístula con clip sobre el endoscopio o clip hemostático.PRINCIPALES MEDIDAS DE VALORACION:El éxito clínico a los 3 meses después del procedimiento. Definido al examen físico, como el cierre completo de todas las fístulas y cese completo del drenaje por la abertura externa, sin cirugía.RESULTADOS:Se estudiaron a ocho pacientes (hombres, 25%, mediana de edad de 45 años (rango intercuartílico, 33-51)). En 7 pacientes, las fístulas se localizaron en la anastomosis ileocolónica o colocolónica y un paciente, en el estómago. Siete pacientes fueron tratados con clip sobre el endoscopio y uno con clip hemostático. Se logró éxito técnico en todos los casos. Se logró éxito clínico a los 3 meses en 75% de los casos (6/8 pacientes). Después de una mediana de 16 meses (rango intercuartílico, 13-23), de seguimiento 3/8 (37,5%) pacientes presentaron cierre de fístulas enterocutáneas y 2/8 (25%) requirieron resección intestinal. No se observaron complicaciones.LIMITACIONES:Estudio retrospectivo, pequeño tamaño de la muestra y heterogeneidad de la población, limitaron la interpretación de los resultados.CONCLUSIONES:Es posible el tratamiento endoscópico de fístulas enterocutáneas con efectividad a corto plazo. Se requieren nuevos estudios para confirmar estos resultados. Consulte Video Resumen en http://links.lww.com/DCR/B614. (Traducción-Dr. Fidel Ruiz Healy).

Baseline Histological Findings Do Not Predict the Risk of Subsequent Extension in Patients with Limited Ulcerative Colitis.

BACKGROUND: Among patients with limited ulcerative colitis (UC), 30% ultimately extend to pancolitis and are at increased risk of adverse clinical outcomes. Risk of endoscopic extension has been found to correlate with clinical features such as early age of onset. AIMS: We sought to determine whether histologic features correlate with disease extension. METHODS: The study population consisted of 40 patients with UC from two large academic centers diagnosed between 2006 and 2017. Eligible cases had a diagnosis of endoscopically limited UC (Montreal E1 or E2) at baseline and ≥ 2 subsequent endoscopic examinations with biopsies. Severity of inflammation was scored using both the Mount Sinai Activity Index and Nancy Histological Index. RESULTS: Patients were divided into two cohorts: those who progressed to pancolitis (Montreal E3) were defined as "Extenders" (n = 21), whereas "Non-extenders" (n = 19) were cases without progression in the follow-up period. The median follow-up time was 58.4 months. The histologic scores in the endoscopically involved mucosa of the index biopsies were not associated with subsequent extension of disease, overall. However, among extender cohort, the index histology scores correlated with biopsy scores at extension (r = 0.455, P = 0.044) and index severity was associated with a shorter time to extension (r = - 0.611, P = 0.003). Furthermore, female patients had a shorter time to extension (P = 0.013). CONCLUSIONS: Histological severity of limited UC is not an independent predictor of extension in UC. However, among patients who subsequently extend, severe inflammation at baseline correlates with shorter progression time and severe inflammation when extension occurs. Patients with limited UC but severe histologic inflammation may warrant more frequent endoscopic surveillance.

Endoscopic treatment of large gastric leaks after gastrectomy using the combination of double pigtail drains crossing a covered stent.

BACKGROUND: Endoscopy is the gold standard for the treatment of postoperative gastric leaks (GL). Large fistulas are associated with high rate of treatment failure. The objective of this study was to assess the clinical efficacy of a combining technique using a covered stent (CS) crossing through pigtails (PDs) for large postsurgical GL leaks. METHODS: All consecutive patients with large (> 10 mm) postsurgical GL treated endoscopically with a combination of a CS and PDs were included in a single-center retrospective study. The primary endpoint was the rate of GL closure. RESULTS: A total of 29 patients were included. Twenty-five patients underwent sleeve gastrectomy. The fistula (median diameter 15 mm) was diagnosed 6 days (IQR 4-9) after surgery. Technical success was observed in all procedures. After a median follow-up of 10.7 months (IQR 3.8-20.7), GL closure was observed in 82.7% with a median time of 63 days (IQR 40-90). Surgical management was finally necessary in four patients after a median of 186 days (IQR 122-250). No complications related to combined endoscopic treatment were observed especially stent migration during the follow-up. CONCLUSION: An endoscopic strategy combining CS crossing through PDs appears to be effective, safe and well tolerated for the treatment of large GL.

No Benefit of Concomitant Immunomodulator Therapy on Efficacy of Biologics That Are Not Tumor Necrosis Factor Antagonists in Patients With Inflammatory Bowel Diseases: A Meta-analysis.

BACKGROUND & AIMS: There is debate over whether patients with inflammatory bowel diseases (IBD) treated with biologics that are not tumor necrosis factor antagonists (such as vedolizumab or ustekinumab) should receive concomitant treatment with immunomodulators. We conducted a meta-analysis to compare the efficacy and safety of concomitant immunomodulator therapy vs vedolizumab or ustekinumab monotherapy. METHODS: In a systematic search of publications, through July 31, 2019, we identified 33 studies (6 randomized controlled trials and 27 cohort studies) of patients with IBD treated with vedolizumab or ustekinumab. The primary outcome was clinical benefit, including clinical remission, clinical response, or physician global assessment in patients who did vs did not receive combination therapy with an immunomodulator. Secondary outcomes were endoscopic improvement and safety. We performed random-effects meta-analysis and estimated odds ratio (OR) and 95% CIs. RESULTS: Overall, combination therapy was not associated with better clinical outcomes in patients receiving vedolizumab (16 studies: OR, 0.84; 95% CI, 0.68-1.05; I2=13.9%; Q test P = .17) or ustekinumab (15 studies: OR, 1.1; 95% CI, 0.87-1.38; I2 = 11%; Q test P = .28). Results were consistent in subgroup analyses, with no difference in clinical remission or response in induction vs maintenance studies or in patients with Crohn's disease vs ulcerative colitis in studies of vedolizumab. Combination therapy was not associated with better endoscopic outcomes in patients receiving vedolizumab (3 studies: OR, 1.13; 95% CI, 0.48-2.68; I2 = 0; Q test P=.96) or ustekinumab (2 studies: OR, 0.58; 95% CI, 0.21-1.16; I2 = 47%; Q test P = .17). Combination therapy was not associated with an increase in adverse events during vedolizumab therapy (4 studies: OR, 1.17; 95% CI, 0.75-1.84; I2 = 0; Q test P = .110). CONCLUSIONS: In a meta-analysis of data from studies of patients with IBD, we found that combining vedolizumab or ustekinumab with an immunomodulator is no more effective than monotherapy in induction or maintenance of remission.

Deep Remission at 1 Year Prevents Progression of Early Crohn's Disease.

BACKGROUND & AIMS: We investigated the effects of inducing deep remission in patients with early Crohn's disease (CD). METHODS: We collected follow-up data from 122 patients (mean age, 31.2 ± 11.3 y) with early, moderate to severe CD (median duration, 0.2 years; interquartile range, 0.1-0.5) who participated in the Effect of Tight Control Management on CD (CALM) study, at 31 sites, representing 50% of the original CALM patient population. Fifty percent of patients (n = 61) were randomly assigned to a tight control strategy (increased therapy based on fecal level of calprotectin, serum level of C-reactive protein, and symptoms), and 50% were assigned to conventional management. We categorized patients as those who were vs were not in deep remission (CD endoscopic index of severity scores below 4, with no deep ulcerations or steroid treatment, for 8 or more weeks) at the end of the follow-up period (median, 3.02 years; range, 0.05-6.26 years). The primary outcome was a composite of major adverse outcomes that indicate CD progression during the follow-up period: new internal fistulas or abscesses, strictures, perianal fistulas or abscesses, or hospitalization or surgery for CD. Kaplan-Meier and penalized Cox regression with bootstrapping were used to compare composite rates between patients who achieved or did not achieve remission at the end of the follow-up period. RESULTS: Major adverse outcomes were reported for 34 patients (27.9%) during the follow-up period. Significantly fewer patients in deep remission at the end of the CALM study had major adverse outcomes during the follow-up period (P = .01). When we adjusted for potential confounders, deep remission (adjusted hazard ratio, 0.19; 95% confidence interval, 0.07-0.31) was significantly associated with a lower risk of major adverse outcome. CONCLUSIONS: In an analysis of follow-up data from the CALM study, we associated induction of deep remission in early, moderate to severe CD with decreased risk of disease progression over a median time of 3 years, regardless of tight control or conventional management strategy.

Safety and efficacy of percutaneous transhepatic-endoscopic rendezvous procedure in a single session.

PURPOSE: To demonstrate the feasibility and safety of PTE-RV performed in a single session. MATERIALS AND METHODS: This is a retrospective review of a prospective database on ERCP between January 2014 and December 2018. PTE-RV was performed in case of second ERCP failure. Technical success was defined as the establishment of an intestinal access to the biliary tract using a PTE-RV procedure allowing an immediate internal biliary drainage. Safety endpoints included intra-operative complications, morbidity and mortality occurring within 30 days after the procedure. RESULTS: Eighty-four patients (44 M/40F) with a median age of 69 years (range 40-91 years) underwent combined PTE-RV. The PTE-RVs were successfully performed in the same session in 80 subjects, resulting in an overall technical success rate of 95.2%. Adverse events were observed in 19% (16/84) of cases. The mortality rate within 30 days after the procedure was 9.5%. CONCLUSION: Percutaneous transhepatic-endoscopic rendezvous technique is feasible in a single session with acceptable level of risk. A randomized trial is required to compare EUBD and PTE-RV.

Complete Endoscopic Healing Associated With Better Outcomes Than Partial Endoscopic Healing in Patients With Crohn's Disease.

BACKGROUND & AIMS: Mucosal healing (MH) has been associated with good outcomes of patients with Crohn's disease (CD). It is not clear what levels of endoscopic healing, based on CD endoscopic index score (CDEIS), associate with different courses of disease progression. We assessed long-term outcomes of patients with CD according to different levels of MH. METHODS: We performed a retrospective study of 84 patients with CD and MH who received biologic therapy (80% with infliximab) from 2008 through 2015 at 2 university hospitals in France and compared outcomes of patients with CD endoscopic index scores (CDEISs) of 0 vs CDEISs greater than 0 but less than 4. Patients were followed until treatment failure or through June 2016. The primary outcome measure was treatment failure, defined by the need for biologic optimization, initiation of corticosteroids, or a Harvey-Bradshaw score above 4 associated with change in treatment, CD-related hospitalization, and/or intestinal resection. RESULTS: After a median follow-up time of 4.8 years (interquartile range, 2.1-7.2), 27 patients (32%) had treatment failure and 3 patients (3.6%) underwent an intestinal resection. Rates of treatment failure were 25% in patients with a CDEIS of 0 and 48% in patients with CDEISs greater than 0 but less than 4 (P = .045). Median times to treatment failure were 21 months (interquartile range, 5-43 months) in patients with a CDEIS of 0 and 13 months (interquartile range, 3.6-35 months) in patients with CDEISs greater than 0 but less than 4 (P = .047). None of the patients with a CEDIS of 0 underwent intestinal resection whereas 11% patients with CDEISs greater than 0 but less than 4 required intestinal resection (P = .031). Patients with a CDEIS of 0 also had a significant lower rate of CD-related hospitalizations than patients with CDEISs greater than 0 but less than 4 (3.5% vs 18%; P = .013). In multivariate analysis, CDEISs greater than 0 but less than 4 (vs CDEIS = 0) was the only factor associated with treatment failure (hazard ratio, 2.6; 95% CI, 1.2-5.8; P = .02). CONCLUSIONS: Complete endoscopic healing (CDEIS = 0) is associated with better long-term outcomes than partial endoscopic healing (CDEIS = 1-4) in patients with CD, as well as fewer surgeries and hospitalizations and an overall decreased risk of treatment failure.

Stopping Mesalamine Therapy in Patients With Crohn's Disease Starting Biologic Therapy Does Not Increase Risk of Adverse Outcomes.

BACKGROUND & AIMS: Little is known about the effects of discontinuing mesalamine therapy for patients with Crohn's disease (CD) who initiate therapy with an anti-tumor necrosis factor (anti-TNF) agent. We analyzed data from 2 national population cohorts to compare outcomes of patients with CD already on mesalamine therapy who started treatment with an anti-TNF agent and then either stopped or continued mesalamine. METHODS: The primary outcome was any adverse clinical event, defined as a composite of new corticosteroid use or CD-related hospitalization or surgery. We collected data from the Truven MarketScan (IBM, Armonk, NY) health claims database in the United States and the Danish health registers. Our analysis included patients with CD who started anti-TNF therapy after at least 90 days of oral mesalamine therapy. Patients were classified as stopping mesalamine if therapy was discontinued within 90 days of starting anti-TNF. We performed multivariable Cox regression models controlling for demographics, clinical factors, and health care utilization. Adjusted hazard ratios with 95% CIs were calculated, comparing stopping mesalamine with continuing mesalamine. RESULTS: A total of 3178 patients with CD were included in our final analysis (2960 in the United States and 218 in Denmark). Stopping mesalamine after initiating anti-TNF therapy was not associated with an increased risk of adverse clinical events in the US cohort (adjusted hazard ratio, 0.89; 95% CI, 0.77-1.03; P = .13) or in the Danish cohort (adjusted hazard ratio, 1.13; 95% CI, 0.68-1.87; P = .63). Similar results were obtained from sensitivity analyses of concomitant immunomodulator use and duration of mesalamine treatment before initiation of anti-TNF therapy. CONCLUSIONS: In a retrospective analysis of 2 national databases, we found that stopping mesalamine therapy for patients with CD who were starting anti-TNF therapy did not increase their risk of adverse clinical events. These results should be validated in a prospective study.