Feasibility of a tailored operative strategy from organ preservation to pelvic exenteration for cT4 rectal cancer depending on neoadjuvant response.

PURPOSE: Improvements in neoadjuvant therapy for locally advanced cT4 rectal cancer have led to improved tumour response and thus a variety of suitable management strategies. The aim of this study was to report management and outcomes of patients with cT4 rectal cancer undergoing a spectrum of treatment strategies from organ preservation (OP) to pelvic exenteration (PE). METHODS: Patients who underwent elective treatment for cT4 rectal cancer between 2016 and 2021 were included. All patients were treated with curative intent. Surgical management was adapted to tumour response. Kaplan-Meier curves were generated to compare 3-year overall survival (3y-OS), local recurrence (3y-LR) and distant metastases (3y-DM) between different strategies. RESULTS: Among 152 patients included, 13 (8%) underwent OP, 71 (47%) TME and 68 (45%) APR/PE. The median follow-up was 31.3 months. Patients undergoing OP had a lower tumour pretreatment (p < 0.001). Compared to patients with TME, those with APR/PE had a higher rate of ypT4 (p = 0.001) with a lower R0 rate (p = 0.044). The 3y-OS and 3y-DM were 78% and 15.1%, respectively, without significant differences. The 3y-LR was 6.6%, and patients with OP had a significantly worse 3y-local regrowth compared to 3y-LR in patients with TME and APR/PE (30.2% vs. 5.4% vs. 2%, p = 0.008). CONCLUSION: cT4 tumours may be suitable for the full spectrum of rectal cancer management from organ preservation to pelvic exenteration depending on tumour response to neoadjuvant therapy. However, careful attention is required in OP as local regrowth in up to 30% of cases reinforces the need for sustained active surveillance in Watch&Wait programmes.

The Crying Need for a Better Response Assessment in Rectal Cancer.

OPINION STATEMENT: Since total neoadjuvant treatment achieves almost 30% pathologic complete response, organ preservation has been increasingly debated for good responders after neoadjuvant treatment for patients diagnosed with rectal cancer. Two organ preservation strategies are available: a watch and wait strategy and a local excision strategy including patients with a near clinical complete response. A major issue is the selection of patients according to the initial tumor staging or the response assessment. Despite modern imaging improvement, identifying complete response remains challenging. A better selection could be possible by radiomics analyses, exploiting numerous image features to feed data characterization algorithms. The subsequent step is to include baseline and/or pre-therapeutic MRI, PET-CT, and CT radiomics added to the patients' clinicopathological data, inside machine learning (ML) prediction models, with predictive or prognostic purposes. These models could be further improved by the addition of new biomarkers such as circulating tumor biomarkers, molecular profiling, or pathological immune biomarkers.

IDEAL Stage 2a/b prospective cohort study of transanal transection and single-stapled anastomosis for rectal cancer.

AIM: There are several anastomotic techniques available to facilitate restorative rectal cancer surgery after total mesorectal excision (TME), including double-stapled anastomosis (DST) and handsewn coloanal anastomosis (CAA). However, to date no one technique is superior with regard to anastomotic leakage (AL) or functional outcomes. Transanal transection single-stapled anastomosis (TTSS) aims to overcome some of the technical challenges and offer comparable clinical and functional outcomes to traditional anastomotic techniques. The aim of this study was to explore the role of TTSS in modern rectal cancer surgery and to provide comparative clinical and functional outcome data with DST and CAA. METHOD: A prospective cohort study was undertaken to assess the safety and clinical and patient-reported outcomes associated with the TTSS procedure. All patients undergoing sphincter-preserving surgery for rectal cancer with an anastomosis performed within 6 cm of the anal verge between January 2016 and April 2021 were prospectively enrolled into this study. Clinical and patient-reported outcome data, including low anterior resection syndrome (LARS) assessment, were collected. The primary endpoint was anastomotic leakage within 30 days. RESULTS: A total of 275 patients participated in this study, with 70 (25%) patients undergoing a TTSS, 110 (40%) undergoing a DST and 95 (35%) undergoing a CAA. Patients undergoing a CAA had more distal tumours than those having a TTSS or DST, with a median tumour height of 5, 7 and 9 cm (p < 0.001), respectively. We observed a statistically significant reduction in AL in the TTSS group compared with the DST group, with rates of 8.6% versus 20.9% (p = 0.028). There was no difference in LARS scores between patients undergoing TTSS and DST (p = 0.228), while patients with a CAA had worse LARS scores than TTSS patients (p = 0.002). CONCLUSION: TTSS is a technically safe and feasible anastomotic technique in rectal cancer surgery as an alternative to DST and CAA. Its advantages over DST are a reduced AL rate and, over CAA, improved function. It should therefore be considered as an alternative technique to improve clinical and patient-reported outcomes in restorative rectal cancer surgery.

Low-impact laparoscopy in colorectal resection-A multicentric randomised trial comparing low-pressure pneumoperitoneum plus microsurgery versus low-pressure pneumoperitoneum alone: The PAROS II trial.

INTRODUCTION: Low-pressure pneumoperitoneum (LLP) in laparoscopy colorectal surgery (CS) has resulted in reduced hospital stay and lower analgesic consumption. Microsurgery (MS) in CS is a technique that has a significant impact with respect to postoperative pain. The combination of MS plus LLP, known as low-impact laparoscopy (LIL), has never been applied in CS. Therefore, this trial will assess the efficacy of LLP plus MS versus LLP alone in terms of decreasing postoperative pain 24 h after surgery, without taking opioids. METHOD: PAROS II will be a prospective, multicentre, outcome assessor-blinded, randomised controlled phase III clinical trial that compares LLP plus MS versus LLP alone in patients undergoing laparoscopic surgery for colonic or upper rectal cancer or benign pathology. The primary outcome will be the number of patients with postoperative pain 24 h after the surgery, as defined by a visual analogue scale rating ≤3 and without taking opioids. Overall, PAROS II aims to recruit 148 patients for 50% of patients to reach the primary outcome in the LLP plus MS arm, with 80% power and an 5% alpha risk. CONCLUSION: The PAROS II trial will be the first phase III trial to investigate the impact of LIL, including LLP plus MS, in laparoscopic CS. The results may improve the postoperative recovery experience and decrease opioid consumption after laparoscopic CS.

Stapled side-to-side anastomosis for ileostomy reversal: a simple and reproducible technique with video.

INTRODUCTION: Protective diverting ileostomy is commonly performed in rectal surgery to avoid septic complications of low colorectal anastomosis. Ileostomy closure usually occurs three months after the surgery and can be realized in two ways: hand sewn or stapled. Existing randomized studies comparing the two techniques showed no difference in terms of complications. METHODS: Our study describes the standard technique of ileostomy reversal as done in Bordeaux University Hospital in 10 steps individually illustrated and with an explicative video. We also collected data concerning the 50 last patients who underwent an ileostomy reversal in our center from June 2021 to June 2022. RESULTS: Mean duration of the ileostomy closure was 46.8 minutes, and the mean total hospital stay was 4.66 days. Five of 50 (10%) patients had a post-operative bowel obstruction, 2/50 (4%) patients had a post-operative bleeding, 1/50 (2%) patient had a wound infection, and there was no anastomotic leakage observed. CONCLUSION: Stapled side-to-side anastomosis is a rapid, simple, and reproducible technique for ileostomy reversal. There are no more complications compared to hand-sewn anastomosis. It engenders an additional cost compensated by the gain in operating time which altogether saves money.

Waiting for bile duct dilation before repair of bile duct injury: a worthwhile strategy?

BACKGROUND: Hepaticojejunostomy (HJ) is the gold standard procedure for repairing major bile duct injury (BDI). Dilation status of the BD before repair has not been assessed as a risk factor for anastomotic stricture. METHOD: This retrospective single-centre study was performed on a population of 87 patients with BDI repaired by HJ between 2007 and 2021. Dilation status was assessed preoperatively, and dilation was defined as the presence of visible peripheral intrahepatic BDs with remaining BD diameter > 8 mm. The short- and long-term outcomes of HJ were assessed according to preoperative dilation status. RESULTS: Before final repair, the BDs were dilated (dBD) in 56.3% of patients and not dilated (ND) in 43.7%. Patients with ND at the time of repair had more severe BDI injury than those with dBD (94.7% vs. 77.6%, p = 0.026). The rate of preoperative cholangitis was lower in patients with ND than in those with dBD (10.5% vs. 44.9%, p = 0.001). The rate of short-term morbidity after HJ was 33.3% (ND vs. dBD: 38.8% vs. 26.3%, p = 0.32). Long-term anastomotic stricture rate was 5.7% with a mean follow-up period of 61.3 months. There were no differences in long-term biliary complications according to dilation status (ND vs. dBD: 12.2% vs. 10.5%, p = 1). CONCLUSION: Dilation status of the BD before HJ for BDI seemed to have no impact on short- or long-term outcomes. Both surgical and radiological external biliary drainages after BDI appear to be acceptable options to reduce cholangitis before repair without increasing risk for long-term anastomotic stricture.

Fetal Growth Velocity according to the Mode of Assisted Conception.

INTRODUCTION: Pregnancies conceived through assisted reproductive techniques (ARTs) are on the rise worldwide and have been associated with a higher risk of placental-related disease in the third trimester. METHODS: A cohort was created of singleton pregnancies after assisted reproduction, admitted at our institution for delivery, between January 2020 and August 2022. Fetal growth velocity from the second trimester to delivery was compared against a gestational-age-matched group of pregnancies spontaneously conceived according to the origin of the selected oocyte (i.e., autologous vs. donated). RESULTS: 125 singleton pregnancies conceived through ART were compared to 315 singleton spontaneous conceptions. Overall, after adjusting for possible confounders, multivariate analysis demonstrated that ART pregnancies had a significantly lower estimated fetal weight (EFW) z-velocity from the second trimester to delivery (adjusted mean difference = -0.002; p = 0.035) and a higher frequency of EFW z-velocity in the lowest decile (adjusted OR = 2.32 [95% CI, 1.15-4.68]). Also, when ART pregnancies were compared according to the type of oocyte, those conceived with donated oocytes showed a significantly lower EFW z-velocity from the second trimester to delivery (adjusted mean difference = -0.008; p = 0.001) and a higher frequency of EFW z-velocity in the lowest decile (adjusted OR = 5.33 [95% CI, 1.34-21.5]). CONCLUSIONS: Pregnancies achieved through ART exhibit a pattern of lower growth velocity across the third trimester, especially those conceived with donated oocytes. The former represents a sub-group at the highest risk of placental dysfunction that may warrant closer follow-up.

Preemptive wirsungostomy: a safe fistula for avoiding a dreadful fistula in elective or planned pancreatoduodenectomy.

BACKGROUND: High-risk pancreatic anastomosis can lead to a high mortality rate after PD due to the development of postoperative pancreatic fistula (POPF). Performing a wirsungostomy by externalizing the pancreatic duct is a poorly known alternative to anastomosis which could reduce the risk of POPF and the associated severe morbidity METHODS: We retrospectively evaluated patients who underwent primary wirsungostomy with PD from January 2007 to December 2021 in our tertiary referral center. Rates of morbidity and mortality with long-term pancreatic functions were studied. RESULTS: Sixty patients were included. The median Updated Alternative Fistula Risk Score (ua-FRS) was 52%, with 95% patients in the high-risk ua-FRS category and 88.3% patients with stage D risk of developing POPF according to the classification of the ISGPS. The mortality rate was 3.3%, and overall 90-day postoperative morbidity was 63.7% with 50% of patients developing major complications. Mean follow-up was 29.8 months. Twelve patients (20%) became diabetic and 35 patients (58.3%) had preserved pancreatic endocrine function CONCLUSION: Preemptive wirsungostomy with PD could be an appropriate procedure for patients with high-risk pancreatic anastomosis. The high associated morbidity could be compromised by the low mortality and preservation of endocrine function compared to total pancreatectomy or severe POPF.

Impact of rheumatoid arthritis on sexuality: adaptation and validation of the Qualisex questionnaire for use in Spain.

Patients with rheumatoid arthritis (RA) have a significantly increased risk of sexual dysfunction. However, it is not properly included in commonly used questionnaires to assess health-related quality of life in RA. Qualisex is a questionnaire developed in France to assess the impact of RA on patients´ sexual function. Our aim was to adapt and validate this questionnaire for use with Spanish RA patients. Two independent translations and a backward translation were obtained. The final version was tested in a pilot study with 10 RA patients to detect any aspects that could hinder interpretation. The validity and reliability of the linguistically validated questionnaire were studied in a multicenter cross-sectional study, with a longitudinal component for reliability estimation. 125 RA patients were included. The response process, discrimination, internal consistency, internal structure, convergent validity (correlation with MGH-SFQ questionnaire, DAS-28, physician global assessment, patient global health assessment, RAID, HAQ, HADS and SF-12©) and reliability were analyzed. The inclusion of two extra items was proposed in the pilot study. The validity analysis detected responses for item 10 that were not coherent with responses for the rest of items. The Cronbach alpha coefficient was 0.971. The highest correlation (0.665) was obtained with MGH-SFQ (questionnaire measuring sexual functioning), followed by RAID (0.516). The intra-class correlation was 0.880 (95% CI 0.815; 0.923), higher than 0.85, which indicates excellent reliability. All parameters used to assess this questionnaire show highly acceptable values. Qualisex allows for a global score of RA patients' sexual functioning and can be self-administered.

Transcutaneous ventriculo-peritoneal shunt catheter extrusion with silent bowel perforation following digestive surgery: a case report.

This case report provides an account of transcutaneous ventriculo-peritoneal (VP) shunt extrusion with silent bowel perforation occurring 2 years post digestive surgery. A 22-year-old man treated since childhood for post-infectious hydrocephalus was referred to our neurosurgery department for an inflammatory wound to the right hypochondrium caused by an abandoned calcified VP shunt. This VP shunt was surgically removed without complications. The perforated bowel required no direct repair. Progress is favorable at 1 year follow-up.

A novel bowel rehabilitation programme after total mesorectal excision for rectal cancer: the BOREAL pilot study.

AIM: Low anterior resection syndrome (LARS) following sphincter-preserving surgery for rectal cancer has a high prevalence, with an impact on long-term bowel dysfunction and quality of life. We designed the bowel rehabilitation programme (BOREAL) as a proactive strategy to assess and treat patients with LARS. The BOREAL programme consists of a stepwise approach of escalating treatments: medical management (steps 0-1), pelvic floor physiotherapy, biofeedback and transanal irrigation (step 2), sacral nerve neuromodulation (step 3), percutaneous endoscopic caecostomy and anterograde enema (step 4) and definitive colostomy (step 5). METHODS: A pilot study was undertaken to assess the feasibility of collecting LARS data routinely with the parallel implementation of the BOREAL programme. All patients who underwent total mesorectal excision for rectal cancer between February 2017 and March 2019 were included. LARS was assessed using the LARS score and the Wexner Faecal Incontinence score at 30 days and 3, 6, 9 and 12 months postoperatively. A good functional result was considered to be a combined LARS score <20 and/or a Wexner score <4. RESULTS: In all, 137 patients were included. Overall compliance with the BOREAL programme was 72.9%. Major LARS decreased from 48% at 30 days postoperatively to 12% at 12 months, with a concomitant improvement in overall good function from 33% to 77%, P < 0.001. The majority of patients (n = 106, 77%) required medical management of their LARS. CONCLUSION: The BOREAL programme demonstrates the acceptability, feasibility and effectiveness of implementing a responsive, stepwise programme for detecting and treating LARS.

Gender-based eating norms, the family environment and food intake among Costa Rican adolescents.

OBJECTIVE: To examine the association between family environment variables (parenting styles, family meal atmosphere), gender-based stereotypes and food intake in Latin American adolescents. DESIGN: Structural equation modelling applied to cross-sectional data, 2017. SETTING: Urban and rural sites of San José, Costa Rica. PARTICIPANTS: n 813; 13-18 years old. RESULTS: Data suggest direct associations between gender-based stereotypes and intake of fruits and vegetables (FV) (ß = 0·20, P < 0·05), unhealthy foods (fast food (FF)) (ß = -0·24, P < 0·01) and ultra-processed foods (ß = -0·15, P < 0·05) among urban girls; intake of legumes among rural girls (ß = 0·16, P < 0·05) and intake of sugar-sweetened beverages (SSB) among rural boys (ß = 0·22, P < 0·05). Family meal atmosphere was associated with legume intake (ß = 0·19, P <·05) among rural girls. Authoritative parenting style was associated with FV intake (ß = 0·23, P < 0·05) among urban boys and FF intake (ß = 0·17, P < 0·05) among urban girls. Authoritarian parenting style was associated with FV consumption (ß = 0·19, P < 0·05) among rural boys, and with SSB and FF consumption (ß = 0·21, P < 0·05; ß = 0·14, P < 0·05, respectively) among urban girls. CONCLUSIONS: Findings are the first to describe the complex family environment and gender-based stereotypes within the context of a Latin American country. They emphasise the need for culturally relevant measurements to characterise the sociocultural context in which parent-adolescent dyads socialise and influence food consumption.

Modelling Longitudinal Directional Associations Between Self-regulation, Physical Activity, and Habit: Results from a Cross-lagged Panel Model.

BACKGROUND: The directionality of associations between self-regulatory variables, behavior, and automaticity is seldomly tested. In this study, we aimed to examine a volitional, self-regulatory sequence of variables proposed in the Health Action Process Approach framework (intention → action plans → action control → behavior) and its relationship with the construct of automaticity of the physical activity habit. METHODS: Longitudinal data was collected from high school students (N = 203, Mage = 15.39 (SD = 1.43), 52% women) at three measurement points. First, a confirmatory factor analysis measurement model was used to examine the study variables across measurement points. Next, a cross-lagged panel model was used to test directionality between variables. RESULTS: After adequate fit of the measurement model was confirmed, a mechanism integrating self-regulation with behavior and automaticity was examined. The hypothesized directionality between variables was verified overall by cross-lagged analysis. However, for the intention-action plan association, the inverse relationship was found: plans were associated with subsequent intentions, but intentions did not predict plans. Moreover, automaticity was not associated with subsequent physical activity behavior. CONCLUSIONS: In general, our findings supported the hypothesized longitudinal direction of the associations, confirming that self-regulation may lead to behavior performance and automaticity. Unexpected findings and implications for intervention and future research are discussed.

Intersectionality between parenting styles, area of residence and gender on food group consumption among Costa Rican adolescents.

Little is known about how parenting styles can influence the adolescent's consumption of sugar-sweetened beverages (SSB), fruits and vegetables (FV) and beans in Latin America. This study uses hierarchical moderated regression models to examine such association by area of residence, sex of the parent and of the adolescent in Costa Rica. Results showed that fathers' authoritarian style was significantly associated with lower intake of sugar-sweetened beverages (SSB) among boys (b = -0.163, p = 0.050), but not girls (b = 0.097, p = 0.114) while mother's authoritarian style was associated with lower SSB intake among girls (b = -0.138, p = 0.031), but not boys (b = 0.159, p = 0.059). Fathers' authoritative style was associated with higher consumption of fruits and vegetables (FV) among boys in rural areas (b=0.440, p= 0.017), but this association was not significant for girls (b=-0.033, p= 0.800) in rural areas or for either gender in urban areas. Parenting styles of the mothers' and fathers' were not significantly associated with Costa Rican adolescent bean consumption, in general or for any of the subgroups. Findings suggest an intersectionality in the effects of parentchild interactions by child and parent sex, cultural and geographic context, and the eating behaviors examined.

Does pre-operative embolization of a replaced right hepatic artery before pancreaticoduodenectomy for pancreatic adenocarcinoma affect postoperative morbidity and R0 resection? A bi-centric French cohort study.

BACKGROUND: Sacrificing a replaced right hepatic artery (rRHA) from the superior mesenteric artery is occasionally necessary to obtain an R0 resection after pancreaticoduodenectomy (PD) for pancreatic adenocarcinoma (PA). Preoperative embolization (PEA) of the rRHA has been proposed to avoid the onset of postoperative biliary and ischemic liver complications. METHODS: Eighteen patients with cephalic PA with an rRHA underwent PEA of the rRHA from 2013 to 2019. The monitoring after embolization and PD was systematic and included a clinical-biological evaluation and a computed tomography scan. This study aimed to determine the feasibility of PEA of the rRHA, postoperative morbidity at 90 days, and quality of oncologic resection after PD. RESULTS: Feasibility of PEA was 100% without complications. A PD was performed in 16/18 patients. Mortality was 2/16 with one death after septic shock with hepatic ischemia without an arterial obstruction. Overall morbidity was 44% including one hepatic abscess after hepatic ischemia (6%). Two resections were R1 (<1 mm) in contact with the origin of the rRHA (2/4 R1). CONCLUSION: PEA of the rRHA before PD was safe and reproducible. PEA of the rRHA followed by en bloc PD resection seems to limit the risk of bilio-hepatic ischemia and could facilitate oncologic resection.

Radiological Simultaneous Portohepatic Vein Embolization (RASPE) Before Major Hepatectomy: A Better Way to Optimize Liver Hypertrophy Compared to Portal Vein Embolization.

OBJECTIVE: The aim of this retrospective study was to compare portal vein embolization (PVE) and radiologica simultaneous portohepatic vein embolization (RASPE) for future liver remnant (FLR) growth in terms of feasibility, safety, and efficacy. SUMMARY OF BACKGROUND DATA: After portal vein embolization (PVE), 15% of patients remain ineligible for hepatic resection due to insufficient hypertrophy of the FLR. RASPE has been proposed to induce FLR growth. MATERIALS AND METHODS: Between 2016 and 2018, 73 patients were included in the study. RASPE was proposed for patients with a ratio of FLR to total liver volume (FLR/TLV) of <25% (RASPE group). This group was compared to patients who underwent PVE for a FLR/TLV <30% (PVE group). Patients in the 2 groups were matched for age, sex, type of tumor, and number of chemotherapy treatments. FLR was assessed by computed tomography before and 4 weeks after the procedure. RESULTS: The technical success rate in both groups was 100%. Morbidity post-embolization, and the time between embolization and surgery were similar between the groups. In the PVE group, the FLR/TLV ratio before embolization was 31.03% (range: 18.33%-38.95%) versus 22.91% (range: 16.55-32.15) in the RASPE group (P < 0.0001). Four weeks after the procedure, the liver volume increased by 28.98% (range: 9.31%-61.23%) in the PVE group and by 61.18% (range: 23.18%-201.56%) in the RASPE group (P < 0.0001). Seven patients in the PVE group, but none in the RASPE group, had postoperative liver failure (P = 0.012). CONCLUSIONS: RASPE can be considered as "radiological associating liver partition and portal vein ligation for staged hepatectomy." RASPE induced safe and profound growth of the FLR and was more efficient than PVE. RASPE also allowed for extended hepatectomy with less risk of post-operative liver failure.

Intraductal papillary mucinous neoplasms of the pancreas and European guidelines: importance of the surgery type in the decision-making process.

BACKGROUND: The European Consensus 2018 established a new algorithm with absolute and relative criteria for intraductal papillary mucinous neoplasms of the pancreas (IPMN) management. The aim of this study was to validate these criteria and analyse the outcomes in function of the surgical procedure and IPMN subtype. METHODS: Clinical, radiological and surgical data (procedure, morbidity/mortality rates) of patients who underwent surgery for IPMN between 2007 and 2017. The predictive value of the different criteria was analysed. RESULTS: 124 patients (men 67%; mean age 65 years) underwent surgery for IPMN (n = 62 malignant tumours; 50%). Jaundice, cyst ≥4 cm and Wirsung duct size 5-9.9 mm or ≥ 10 mm were significantly associated with malignancy (4.77 < OR < 11.85 p < 0.0001). The positive predictive value of any isolated criterion ranged from 71 to 87%, whereas that of three relative criteria together reached 100%. The mortality and morbidity (grade III-IV complications according to the Dindo-Clavien classification) rates were 3 and 8%, respectively. Morbidity/mortality after duodenopancreatectomy and total pancreatectomy were significantly higher for benign IPMN (p = 0.01). CONCLUSION: Considering the morbidity associated with extended surgery, particularly for benign IPMN, the results of the present study suggest that high-risk surgery should be considered only in the presence of three relative criteria and including the surgery type in the decision-making algorithm.

Long-term continuation of methotrexate therapy in giant cell arteritis patients in clinical practice.

OBJECTIVES: To assess the long-term continuation of methotrexate (MTX) in a cohort of patients with giant cell arteritis (GCA) in daily clinical practice. Factors associated with its discontinuation rate were also investigated. METHODS: A longitudinal study from 1991-2014, was performed. GCA patients with MTX and followed-up in a rheumatology outpatient clinic of Madrid during the study period were included. PRIMARY OUTCOME: discontinuation of MTX due to: adverse drug reactions (ADR moderate and severe); inefficacy; sustained clinical response; patient decision. Covariables: sociodemographic, clinical and therapy. Incidence rates (IR) of MTX discontinuation per 100 patient-years with their 95% confidence interval (CI) were estimated using survival techniques. Factors associated to specific discontinuation causes were analysed using Cox models. RESULTS: We included 108 patients (244 patient-years). The IR was 37.2 [30.3-45.7]. The IR due to ADR, severe ADR, sustained clinical response and inefficacy was 20.8 [15.8-27.4]; 5.7 [3.3-9.6]; 8.2 [5.3-12.7] and 2.8 [1.3-6.0], respectively. Regarding multivariate analysis, younger patients, baseline cardiovascular disease, taking more glucocorticoids and lower initial doses of MTX were associated to a higher discontinuation rate due to inefficacy. Factors influencing the suspension due to ADRs were: older age, baseline. Chronic obstructive pulmonary disease, higher baseline erythrocyte sedimentation rate, several specific clinical patterns at diagnosis, and higher maximum dose of MTX during the follow up. In the final model for sustained clinical response older patients and more recurrences were independently associated to less discontinuation rate. CONCLUSIONS: We provide further data of the potential safety of long-term MTX in the management of GCA. We have also found several factors influencing the continuation of MTX.