Long-term Follow-up Results Research Articles

Photodynamic therapy for nodular basal cell carcinoma up to 5mm located on high-risk area: effectiveness and long-term follow-up results

SignificanceResponse rates evaluation of photodynamic therapy (PDT) for nodular basal cell carcinoma (BCC) treatment located on high-risk and low-risk areas of the face. ApproachTwo groups of nodular BCC were selected, debulked, and received 20% methyl aminolevulinate cream. After 3h, the first irradiation was performed (20min, 150J/cm2). Then, the cream was re-applied, and a second irradiation was performed after 1.5h (20min, 150J/cm2). Clearance at 30 days and recurrence-free survival rate were evaluated. ResultsThe clearance at 30 days after PDT was 89% for the low-risk area group and 87% for the high-risk group. The recurrence-free survival at 60 months was 82% and 85% for the high-risk and low-risk groups, respectively. ConclusionsNo significant differences were observed between groups, nor for clearance at 30 days, nor recurrence-free follow-up. These results make the PDT an option for nodular BCC less than 5 mm located in high-risk areas.

Enhancing outcome prediction by applying the 2019 WHO DM classification to adults with hyperglycemic crises: A single-center cohort in Thailand

Background and aimsHyperglycemic crisis is a metabolic catastrophe which can occur in any type of diabetes. In 2019, the World Health Organization (WHO) revised the classification of diabetes mellitus (DM) and established two new hybrid forms, latent autoimmune diabetes in adults (LADA) and ketosis-prone type 2 diabetes (T2D). This study aimed to determine clinical outcomes after a hyperglycemic crisis event in people with diabetes classified subtypes by 2019 WHO DM classification. MethodsA five-year (2015–2019) retrospective study of adult patients admitted with hyperglycemic crises was conducted. Types of diabetes were recategorized based on the 2019 WHO DM classification. Clinical characteristics, in-admission treatment and complications, long-term follow-up outcomes, and mortality were collected, analyzed, and compared. ResultsA total of 185 admissions occurred in 136 patients. The mean age was 50.6 ± 18.4 years (49.3 % men). The annual average incidence of hyperglycemic crises was 5.2 events/1000 persons. The proportion of type 1 diabetes, T2D, LADA, ketosis-prone T2D, and pancreatic DM were 15.4 %, 69.1 %, 2.2 %, 11 %, and 2.2 %, respectively. In-hospital mortality was 3.7 % while cumulative mortality totaled 19.1 %. During the 24-month follow-up, ketosis-prone T2D had the highest success of insulin discontinuation (HR 6.59; 95 % CI 6.69–319.4; p < 0.001), while T2D demonstrated the highest mortality compared to others (HR, 2.89; 95%CI 1.15–6.27; p = 0.02). ConclusionThe reclassification of diabetes based on 2019 WHO DM classification helped elucidate differences in long-term outcomes and mortality among DM types. The new classification, which separates ketosis-prone T2D from standard T2D, should be encouraged in clinical practice for precise and individualized management.

Long-term follow-up of non-myasthenic patients with early-stage thymoma who underwent extended thymectomy or limited resection

BackgroudThe standard resection for early-stage thymoma is total thymectomy and complete tumour excision with or without myasthenia gravis but the optimal surgery mode for patients with early-stage non-myasthenic thymoma is debatable. This study analysed the oncological outcomes for non-myasthenic patients with early-stage thymoma treated by thymectomy or limited resection in the long term. MethodsPatients who had resections of thymic neoplasms at Taipei Veteran General Hospital, Taiwan between December 1997 and March 2013 were recruited, exclusive of those combined clinical evidence of myasthenia gravis were reviewed. A total of 113 patients were retrospectively reviewed with pathologic early stage (Masaoka stage I and II) thymoma who underwent limited resection or extended thymectomy to compare their long-term oncologic and surgical outcomes. ResultsThe median observation time was 134.1 months [interquartile range (IQR) 90.7–176.1 months]. In our cohort, 52 patients underwent extended thymectomy and 61 patients underwent limited resection. Shorter duration of surgery (p < 0.001) and length of stay (p = 0.006) were demonstrated in limited resection group. Six patients experienced thymoma recurrence, two of which had combined myasthenia gravis development after recurrence. There was no significant difference (p = 0.851) in freedom-from-recurrence, with similar 10-year freedom-from-recurrence rates between the limited resection group (96.2 %) and the thymectomy group (93.2 %). Tumour-related survival was also not significantly different between groups (p = 0.726).result ConclusionPatients with early-stage non-myasthenic thymoma who underwent limited resection without complete excision of the thymus achieved similar oncologic outcomes during the long-term follow-up and better peri-operative results compared to those who underwent thymectomy.

Long-term follow-up results of a pilot study for nodular basal cell carcinoma with PDT using partial home treatment protocol

SignificanceEvaluate a photodynamic therapy (PDT) protocol with less time at the hospital and less painful for low-risk basal cell carcinoma (BCC) treatment. ApproachEight BCCs were selected, debulked, and received 20% methyl aminolevulinate cream. After 3h, the first irradiation was performed at the hospital (20min, 150J/cm2). Then, the cream was re-applied, a portable irradiation prototype was fixed into the lesion. After 1.5h, the patients turned on the prototype for irradiation (2h, 312J/cm2) at home. Disease-free survival rate and pain score during irradiations were evaluated. ResultsThe clearance at 30 days after PDT was 87.5% by histological analysis. The mean follow-up was 21.5 months and the recurrence-free survival at 22 months was 75%. The pain score was significantly lower at home. ConclusionsA less painful and more comfortable PDT treatment protocol was proved long-term efficient. A randomized clinical trial has been conducted to confirm these results.

Long-term follow-up results from KEYNOTE-041: Phase 1b study of pembrolizumab in Japanese patients with advanced melanoma.

Pembrolizumab demonstrated an acceptable safety profile and promising antitumor activity in Japanese patients with advanced melanoma in the phase 1b KEYNOTE-041 (Study of Pembrolizumab [MK-3475] in Participants With Advanced Melanoma) trial. To evaluate the long-term efficacy and safety of pembrolizumab in Japanese patients with advanced melanoma in KEYNOTE-041. The current analysis reports results of additional follow-up of approximately 12 months since the initial analysis. Eligible patients had locally advanced (unresectable stage III) or metastatic (stage IV) melanoma not amenable to local therapy and had received two or fewer prior systemic therapies. Pembrolizumab 2 mg/kg was given every 3 weeks for up to 2 years or until confirmed progression or unacceptable toxicity. Primary end points included safety, tolerability, and overall response rate (ORR) per Response Evaluation Criteria in Solid Tumors version 1.1 by independent central review. The data cutoff for this analysis was August 30, 2017. Forty-two patients were followed up for a median of 22.3 months (range, 2.63-30.82 months). The ORR was 24.3% (nine of 37 evaluable patients [95% confidence interval (CI), 11.8%-41.2%]). Two patients with partial response at the time of the initial analysis achieved complete response. The median overall survival (OS) was 25.1 months (95% CI, 13.1-not reached] and the 30-month OS rate was 46.3% (95% CI, 29.8%-61.3%). The median duration of response was not reached. Treatment-related adverse events (TRAEs) were reported in 78.6% of patients; the incidence of grade 3 to 5 TRAEs was 23.8%. No additional treatment-related deaths occurred since the initial analysis. Pembrolizumab provided durable antitumor activity and an acceptable safety profile in Japanese patients with advanced melanoma.

Long-Term Follow-Up Outcomes in Women with In Situ/Microinvasive Adenocarcinoma of the Uterine Cervix Undergoing Conservative Treatment-Cervical Adenocarcinoma Study Group Italian Society of Colposcopy and Cervico-Vaginal Pathology.

The present study aimed to assess long-term follow-up outcomes in women with in situ/microinvasive adenocarcinoma (AC) of the uterine cervix treated conservatively. Retrospective multi-institutional study including women with early glandular lesions and 5-year follow-up undergoing fertility-sparing treatment. Independent variables associated with recurrence were evaluated. Logistic regression analysis and Kaplan-Meier survival analysis with Logrank test were performed. Of 269 women diagnosed with in situ/microinvasive AC, 127 participants underwent conservative treatment. During follow-up, recurrences were found in nine women (7.1%). The only factor associated with recurrence during follow-up was positive high-risk Human Papillomavirus (hr-HPV) testing (odds ratio 6.21, confidence interval 1.47-26.08, p = 0.012). HPV positivity in follow-up showed a recurrence rate of 21.7% against 3.8% in patients who were HPV-negative (p = 0.002, Logrank test). Among women with negative high-risk HPV tests in follow-up, recurrences occurred in 20.0% of non-usual-type histology vs. 2.1% of usual-type cases (p = 0.005). HPV testing in follow-up is of pivotal importance in women with early glandular lesions undergoing conservative treatment, given its recurrence predictive value. However, women who are high-risk HPV-negative in follow-up with non-usual-type histopathology may represent a sub-population at increased risk of recurrences. Further studies should confirm these findings.

Long-Term Follow-Up Results After In Situ Laser Fenestrated Endovascular Treatment of Abdominal Aortic Aneurysms

Long-Term Follow-Up Results After In Situ Laser Fenestrated Endovascular Treatment of Abdominal Aortic Aneurysms

Health-related quality of life measures in patients undergoing decompressive craniectomy for severe traumatic brain injury: a 6-year follow-up analysis

Purpose We aimed to assess the long-term neurological outcomes and the functionality and QoL in patients undergoing decompressive craniectomy for severe traumatic brain injury, respectively. Materials and methods Among the 120 patients who underwent decompressive craniectomy for severe TBI between 2002 and 2007, 101 were included based on the inclusion criteria. Long-term follow-up results (minimum 3 years) were available for 22 patients. The outcomes were assessed using the Glasgow Outcome Scale (GOS) and the functionality and HRQoL were assessed using the Short Form-36 (SF-36) (v2) and Quality of Life After Brain Injury (QoLIBRI) questionnaires. Results Among the patients with severe TBI, 62 (61.4%) died and 39 (38.6%) were discharged to either home or a physical therapy facility. Eleven of the thirty-nine patients could not be reached and were excluded from the final analysis. The mean GOS of the remaining 28 patients was 4.14 ± 0.8 after 6.46 ± 1.64 years of follow-up. The HRQoL was assessed in 22 of the 28 patients. The HRQoL scores were lower in patients with TBI than in healthy controls. Furthermore, there was a significant difference in the HRQoL scores in patients with improved GOS scores than in those with unimproved GOS scores. Conclusions Health-related outcome scores could help clinicians understand the requirements of survivors of severe TBI to create a realistic rehabilitation target for them. QoLIBRI served as a good way of communication in these subjects.

Recurrence of new-onset post-operative AF after cardiac surgery: detected by implantable loop recorders: A systematic review and Meta-analysis

BackgroundAtrial fibrillation (AF) is one of the most common complications after cardiac surgery. New-onset post-operative AF may signal an elevated risk of AF and associated outcomes in long-term follow-up. We aimed to estimate the rate of AF recurrence as detected by an implantable loop recorder (ILR) in patients experiencing post-operative AF within 30 days after cardiac surgery. MethodsWe searched MEDLINE, Embase and Cochrane CENTRAL to April 2023 for studies of adults who did not have known AF, experienced new-onset AF within 30 days of cardiac surgery and received an ILR. We pooled individual participant data on timing of AF recurrence using a random-effects model with a frailty model applied to a Cox proportional hazard analysis. ResultsFrom 8671 citations, 8 single-centre prospective cohort studies met eligibility criteria.Data were available from 185 participants in 7 studies, with a median follow-up of 1.7 (IQR: 1.3–2.8) years. All included studies were at a low risk of bias. Pooled AF recurrence rates following 30 post-operative days were 17.8% (95% CI 11.9%–23.2%) at 3 months, 24.4% (17.7%–30.6%) at 6 months, 30.1% (22.8%–36.7%) at 12 months and 35.3% (27.6%–42.2%) at 18 months. ConclusionsIn patients who experience new-onset post-operative AF after cardiac surgery, AF recurrence lasting at least 30 s occurs in approximately 1 in 3 in the first year after surgery. The optimal frequency and modality to use for monitoring for AF recurrence in this population remain uncertain.

Relationship between high sensitivity troponin I and clinical outcomes in non–acute coronary syndrome (non-ACS) acute heart failure patients – a one-year follow-up study

ObjectiveThe primary objective of the study was to investigate the correlation between high-sensitivity troponin I (hsTropI) levels during hospitalization and the prognostic outcome in patients with non-acute coronary syndrome (non-ACS) acute heart failure, over a follow-up period of one year. The secondary objective was to assess and characterize acute heart failure during index hospitalization. MethodsHigh sensitivity troponin I value was noted both at the time of admission and discharge. The correlation of admission hsTropI along with other parameters and risk factors with in-hospital mortality was studied. Patients of index hospitalization after discharge were followed up for one year and the composite endpoint of cardiovascular death or re-hospitalization for heart failure was noted. The correlation between admission and discharge hsTropI values with the composite endpoint was then analyzed. ResultsOut of 350 patients, 38 (10.8 %) patients died during index hospitalization while 142 patients (46 %) developed composite outcomes during follow-up. Age, previous history of heart failure, atrial fibrillation, low left ventricular ejection fraction, systolic blood pressure, and high values of hsTropI above 99th percentiles were independent in-hospital mortality predictors. The value of hsTropI at the time of admission was not associated with poor composite outcome during follow-up. However, patients who showed an increasing trend of hsTropI value at the time of discharge were found to have a significant increase in the composite outcome. ConclusionHigh-sensitivity troponin I is a valuable biomarker that can predict in-hospital mortality and long-term follow-up outcomes in patients with acute heart failure. It plays a crucial role in developing improved strategies for heart failure surveillance and management in the community.

Classification and a decade-long follow-up of rat bite injuries in the nasal region

BackgroundNasal defects due to rat bites are frequently encountered in rural regions of China. In addition to serving as disease vectors, rats can also inflict bite injuries. In this study, we delineated the characteristics of rat bite injuries in the nasal region and discussed the clinical features observed during a 10-year follow-up period. MethodsWe retrospectively reviewed hospital records for patients admitted due to rat bites. This study outlines the demographics, clinical features, and follow-up outcomes supported by comprehensive photo documentation of the patients’ progress. ResultsTwenty-five patients, with a mean age of 29 years, were admitted due to rat bites. Treatment was provided for three distinct types of injuries: nasal tip defect (type I), nasal defect (type II), and full-thickness nasal defect with loss of surrounding tissues (type III). All patients recovered fully. ConclusionsThe treatment for rat bites should be based on the wound type. The long-term follow-up outcomes are more favorable when fewer subunits of the nose affected. We recommend early surgical intervention, along with psychological therapy, to prevent interference with growth and development.

Reverse dorsolateral proximal phalangeal island flap: Long-term results

ObjectivesThis study aims to present long-term follow-up results of the reverse dorsolateral proximal phalangeal island flap designed for reconstruction of large fingertip and pulp defects. MethodsWe examined 18 patients who underwent reverse dorsolateral proximal phalangeal island flap surgery to address ≥2.5 cm fingertip and pulp defects. Mean follow-up was 84.4 months. Sensitivity assessments were conducted using the Semmes–Weinstein monofilament and 2-point discrimination tests. Additionally, we evaluated finger joint active range of motion, complications and cold intolerance. ResultsMild venous congestion was observed in 5 flaps. Significant differences were observed in 2-point discrimination and Semmes-Weinstein monofilament tests between the injured and contralateral sides, specifically in the flaps, the dorsal side of the middle phalanx, and the donor site. The flap's mean static 2-point discrimination was 8.3 mm. Restricted distal interphalangeal joint extension was observed in 2 cases. Total active motion with the flap was good or excellent in the injured fingers, but with a significant difference between injured and contralateral fingers. Additionally, 42% of the injured fingers exhibited hook nail deformity, and 2 patients reported cold intolerance. Despite these issues, most patients has high scores for the appearance and satisfaction aspects of the Michigan Hand Outcomes Questionnaire. ConclusionIn moderate or larger fingertip defects, the reverse dorsolateral proximal phalangeal island flap serves as an alternative for reconstructing both fingertip and pulp issues. However, this option involves sacrificing some sensation in the dorsum of the middle phalangeal finger and the donor area. Level of evidenceIV, therapeutic study.

Round ligament management during minimally invasive groin hernia repair in women: a systematic review and meta-analysis.

Female sex has been associated with worse outcomes after groin hernia repair (GHR), including a higher rate of chronic pain and recurrence. Most of the studies in GHR are performed in males, and the recommendations for females extrapolate from these studies, even though females have anatomy intricacies. The round ligament of the uterus (RLU) is associated with pelvic stabilization and plays a role in sensory function. Transection of the RLU during GHR is controversial as it can allow easier mesh placement but can favor genitourinary complications and chronic pain. As no previous meta-analysis compared preserving versus transecting the RLU during minimally invasive (MIS) GHR, we aim to perform a systematic review and meta-analysis evaluating surgical outcomes comparing the approaches. Cochrane Central, Embase, and PubMed databases were systematically searched for studies comparing transection versus preservation of the RLU in MIS groin hernia surgeries. Outcomes assessed were operative time, bleeding, surgical site events, hospital stay, chronic pain, paresthesia, recurrence rates, and genital prolapse rates. Statistical analysis was performed using RevMan 5.4.1. Heterogeneity was assessed with I2 statistics. A review protocol for this meta-analysis was registered at PROSPERO (CRD 42023467146). 1738 studies were screened. A total of six studies, comprising 1131 women, were included, of whom 652 (57.6%) had preservation of the RLU during MIS groin hernia repair. We found no statistical difference regarding chronic pain, paresthesia, recurrence rates, and postoperative complications. We found a longer operative time for the preservation group (MD 6.84min; 95% CI 3.0-10.68; P = 0.0005; I2 = 74%). Transecting the RLU reduces the operative time during MIS GHR with no difference regarding postoperative complication rates. Although transection appears safe, further prospective randomized studies with long-term follow-up and patient-reported outcomes are necessary to define the optimal management of RLU during MIS GHR.

Solid pseudopapillary neoplasms of the pancreas: Multicenter Vasepa study

IntroductionSolid pseudopapillary tumors (SPT) of the pancreas are rare exocrine neoplasms of the pancreas. Correct preoperative diagnosis is not always feasible. The treatment of choice is surgical excision. These tumors have a good prognosis with a high disease-free survival rate. ObjectiveTo describe the clinicopathological and radiological characteristics as well as short- and long-term follow-up results of patients who have undergone SPT resection. MethodsMulticenter retrospective observational study in patients with SPT who had undergone surgery from January 2000–January 2022. We have studied preoperative, intraoperative, and postoperative variables as well as the follow-up results (mean 28 months). Results20 patients with histological diagnosis of SPT in the surgical specimen were included. 90% were women; mean age was 33.5 years (13–67); 50% were asymptomatic. CT was the most used diagnostic test (90%). The most frequent location was body-tail (60%). Preoperative biopsy was performed in 13 patients (65%), which was correct in 8 patients. Surgeries performed: 7 distal pancreatectomies, 6 pancreaticoduodenectomies, 4 central pancreatectomies, 2 enucleations, and 1 total pancreatectomy. The R0 rate was 95%. Four patients presented major postoperative complications (Clavien-Dindo > II). Mean tumor size was 81 mm. Only one patient received adjuvant chemotherapy. With a mean follow-up of 28 months, 5-year disease-free survival was 95%. ConclusionSPT are large, usually located in the body-tail of the pancreas, and more frequent in women. The R0 rate obtained in our series is very high (95%). The oncological results are excellent.

Long-term follow-up of inpatients with meniscus tears who received integrative Korean medicine treatment: A retrospective analysis and follow-up survey.

Evidence regarding the use of Korean medicine (KM) for the conservative treatment of meniscus tears remains lacking. We aimed to evaluate clinical effectiveness and long-term follow-up outcomes in patients undergoing integrative KM treatment for meniscus tears. We analyzed the electronic medical records (EMRs) of 86 patients with meniscus tears and administered a follow-up survey. Patients treated at 1 of 4 KM hospitals between June 1, 2015, and June 30, 2020, were reviewed. KM treatment comprised herbal medicine, acupuncture, pharmacopuncture, bee venom pharmacopuncture, Chuna therapy, and KM physiotherapy. The primary outcome was the numeric rating scale (NRS) score for knee pain; secondary outcomes were the Western Ontario and McMaster Universities Arthritis Index (WOMAC), EuroQol 5-dimension (EQ-5D) score, range of motion, and patient global impression of change. The NRS for knee pain was reduced by an average of 2.49 (95% confidence interval [CI]: 2.03-2.95) at discharge and 1.97 (95% CI: 2.03-2.95) at follow-up. The WOMAC decreased by an average of 15.52 (95% CI: 10.14-20.89) during hospital stay and 30.72 (95% CI: 24.58-36.87) at follow-up. The EQ-5D score increased by an average of 0.06 (95% CI: -0.14 to 0.02) at discharge and 0.19 (95% CI: -0.29 to -0.09) at follow up. KM treatment effectively reduced knee pain, improved knee joint function, and enhanced the quality of life in patients with a meniscus tear for a relatively long period after treatment.

The Impact Of Thymectomy In Thymomatous And Nonthymomatous Myasthenia Gravis - The Experience Of A Tertiary Center.

Thymectomy remains a mainstay of treatment in Thymomatous (T) and Nonthymomatous (nT) Myasthenia Gravis (MG), with improved clinical outcomes and reduced need for medical treatment, however, there is little research regarding long-term follow-up. We aim to assess the impact of surgery on the long-term outcome of patients with MG at our center. Retrospective analyses of MG patients submitted to thymectomy between 2007 and 2017 at the thoracic surgery department of CHUC. Clinical assessment was performed according to the MG Foundation of America (MGFA) Clinical Classification (cMGFA). The follow-up was categorized according to the MGFA Post-intervention Status (MGFA-PIS) and cMGFA. Statistical analysis was performed with SPSS, to a significance level of 5%. Thirty-seven patients underwent extended thymectomy and 67.6% were female. Median age at diagnosis was 46.68±19.2 years. Most patients (83.8%) had anti-acetylcholine receptor antibodies and 81.1% had generalized forms of MG. Many patients (67.6%) had surgery less than 12 months after the clinical diagnosis. TMG was present in 19 (51.4%) patients. Compared to nTMG, these patients were older (54.06±17.9 vs 40.17±19.4 years) and most were men (52.9% vs 16.7%). We obtained a good outcome in most patients in the first (81.1%), second (86.1%), and fifth (84.8%) year of follow-up. There was a shift towards better prognosis categories in the good outcome group: 9.1% CSR, 3.0% PR, and 66,7% MM in the fifth year. Preoperative medical treatment did not influence the long-term follow-up outcome. A shorter time to surgery (< 12 months) correlated with better outcomes at year 5 (p=0.016). Thymectomy led to a sustained clinical improvement in our cohort, allowing for a reduced need for medication. A shorter time to surgery seems to have a positive influence on long-term prognosis. We expect that an extended follow-up would improve our results.

Jednostronna jaskra wrodzona z wolooczem u dwóch sióstr – opis przypadków z długoterminową obserwacją

Primary congenital glaucoma is a rare condition but the most common form of glaucoma in infants. It occurs with variable frequency in different countries and ethnic groups. It is considered an autosomal recessively inherited disorder, but is known to occur as a result of de novo genetic mutations. It causes increased intraocular pressure on the background of congenital iridotrabeculodysgenesis and is a cause of severe optic neuropathy due to apoptotic degeneration of the retinal ganglion cell layer. We present the description of siblings with unilateral ipsilateral congenital glaucoma. Both sisters had corneal opacity and one had Haab’s striae at the time of diagnosis. Both patients underwent trabeculectomy by age one, less than 6 months after diagnosis. Results of regular follow-up examinations and long-term follow-up showed no changes in retinal morphology, no progression of the disease, and intraocular pressure stabilized over the long term.

Feasibility and safety of laparoscopic radical cystectomy for male octogenarians with muscle-invasive bladder cancer

This study was designed to evaluate the safety and feasibility of laparoscopic radical cystectomy (LRC) for male octogenarian patients with muscle-invasive bladder cancer (MIBC). Briefly, a total of 57 male octogenarian patients (A group) with bladder carcinoma were enrolled and underwent LRC and intracorporeal pelvic lymph node dissection with bilateral cutaneous ureterostomy from May 2016 to December 2022. Besides, 63 male patients (age < 80 years old) with bladder carcinoma undergoing LRC and 17 octogenarian male patients with bladder carcinoma undergoing open radical cystectomy (ORC) were enrolled in B and C groups as control. All perioperative clinical materials and outcomes of long-term follow-up, and complication were collected. The specific results were shown as follows. Compared with C group, the operation time and resected lymph node in A group was increased, and the estimated blood loss, the number of transfusion needed, duration of pelvic drainage and hospital stay after surgery was decreased. The death rate and ileus complication rate were higher in A group (12 cases) than in C group (15 cases). The cases of ureteral stricture in A group (13 cases) was decreased compared with that in C group. Overall, LRC and bilateral cutaneous ureterostomy are safe, feasible and better choices for the treatment of male octogenarian patients with MIBC. The octogenarian receiving cutaneous ureterostomy heals slowly and exists certain incomplete intestinal obstruction after surgery.

The Whitaker test: a predictive tool for evaluating the surgical efficacy of upper urinary tract reconstruction in patients carrying a nephrostomy tube after surgery.

To explore the role of the Whitaker test in evaluating the postoperative outcome of upper urinary tract reconstruction surgery in patients carrying a nephrostomy tube after surgery. This was a prospective observational study performed in 42 patients with nephrostomy tube undergoing the Whitaker test after upper urinary tract reconstruction surgery between January 2020 and December 2021. Data on clinical information, the Whitaker test and surgical procedure were collected prospectively, and the long-term follow-up results were analysed retrospectively. The 46 ureters of 42 patients (right 16, left 22, bilateral 4) underwent six common upper urinary tract surgical reconstruction procedures and one combined procedure, including pyeloplasty, ureteroureterostomy, lingual mucosal onlay graft, appendiceal onlay flap, ureteral reimplantation, Boari flap, and ipsilateral lingual mucosal onlay graft combined ureteral reimplantation. All patients underwent the Whitaker test successfully without any discomfort after examination. The postoperative Whitaker test showed 43 kidneys without obstruction and 3 kidneys with obstruction. At a median follow-up of 18 months (range 13-31), the follow-up results showed that the overall success rate of the surgery was 100% (46/46). Concerning the concordance Whitaker test and follow-up results, the observed proportion of agreement was 93.5% (43/46). The Whitaker test can achieve similar consistency with the long-term follow-up results after upper urinary tract reconstruction surgery and can be used as a tool to evaluate the surgical efficacy of upper urinary tract reconstruction surgery, which can provide a prognostic efficacy evaluation for patients carrying a nephrostomy tube after surgery.

P541 Long-term follow-up results of darvadstrocel for complex perianal fistulas in patients with Crohn's disease: 3-year outcomes from a Japanese phase 3 study

Abstract Background Darvadstrocel (DVS), a suspension of expanded human allogeneic mesenchymal stem cells extracted from adipose tissue, is for the treatment of complex perianal fistulas in patients with Crohn's disease (CD). In Japan, DVS was approved in 2021 based on the Japanese phase 3 study Week 52 data combined with the pivotal study ADMIRE-CD data. Patients who participated in the Japanese study were monitored for 3 years, and we report the results at Week (W) 156. Methods This was an open-label, uncontrolled, phase 3 study (converted to a post-marketing clinical study after approval) conducted from March 2019 to February 2023 in Japan. Subjects had complex Crohn’s perianal fistulas (CPF) refractory to conventional treatments with a maximum of 2 internal openings (IO) and 3 external openings (EO). The fistula tract was curetted approximately 2-3 weeks before DVS administration, and a drainage seton was placed. On the day of administration, seton was removed, fistula tracts were curetted again, and IO was sutured. A total of 24 mL of DVS (including 120x106 cells) was administered around the IO and into the wall of fistula tracts. During the 2-year follow-up period after W52, medical and surgical treatment for CD and CPF was given as needed, and subjects were assessed every 6 months. Results 22 Japanese patients were enrolled from 9 sites. The mean (SD) age was 36.4 (10.4) years, 63.6% were male, and the mean (SD) duration of CD was 11.3 (6.6) years. By W156, most frequently reported adverse events (AE) were anal fistula (7/22), proctalgia (7/22), and nasopharyngitis (6/22). New serious AE occurred after W52 were found in 9 subjects: COVID-19 (4), CD (2), perianal fistula, small bowel obstruction, premature labour (1 each). None of these were considered DVS-related. At W156, the combined remission rate (clinical and MRI assessment) was 15/22 (68.2%, 95% CI [48.7%, 87.6%]), clinical remission rate (clinical assessment) was 15/22 (68.2%, 95% CI [48.7%, 87.6%]), response rate (no drainage from ≥50% of treated EOs) was 20/22 (90.9%, 95% CI [78.9%, 100.0%]), and relapse rate (at least 1 relapse by W156 after achieving remission at W52) was 3/15 (20.0%, 95% CI [0.0%, 40.2%]). Mean Perianal Disease Activity Index (PDAI) total score (SD) was 4.8 (2.2) at baseline, which was decreased to 2.1 (2.1) at W52, and 1.7 (2.0) at W156. Mean Crohn's Disease Activity Index (CDAI) total score (SD) was 94.3 (60.1) on the day of administration, which was decreased to 73.7 (73.6) at W52, and 71.4 (51.2) at W156. Conclusion This is the first prospectively observed clinical outcomes in CPF for 3 years after DVS administration. There were no new safety findings, and fistula remission observed at W52 was maintained until W156.