Stereotactic MR-guided adaptive radiotherapy (SMART) for primary rectal cancer: evaluation of early toxicity and pathological response.

Background: The purpose of this study is to measure the effects of stereotactic MR-guided adaptive radiotherapy (SMART) for rectal cancer patients in terms of early toxicity and pathological response. Materials and methods: For this prospective pilot study, patients diagnosed with locally advanced rectal cancer (LARC) with positive lymph node clinical staging underwent SMART on rectal lesion and mesorectum using hybrid MR-Linac (MRIdian ViewRay). Dose prescription at 80% isodose for the rectal lesion and mesorectum was 40 Gy (8 Gy/fr) and 25 Gy (5 Gy/fr), respectively, delivered on 5 days (3 fr/week). Response assessment by MRI was performed 3 weeks after SMART, then patients fit for surgery underwent total mesorectal excision. Primary endpoint was evaluation of adverse effect of radiotherapy. Secondary endpoint was pathological complete response rate. Early toxicity was graded according to the Common Terminology Criteria for Adverse Events (CTCAE v5.0). Results: From October 2020 to January 2022, twenty patients underwent rectal SMART. No grade 3-5 toxicity was recorded. Twelve patients were eligible for total mesorectal excision (TME). Mean interval between the completion of SMART and surgery was 4 weeks. Pathological downstaging occurred in all patients; rate of pathological complete response (pCR) was 17%. pCR occurred with a prolonged time to surgery (> 7 weeks). Conclusion: To our knowledge, this is the first study to use stereotactic radiotherapy for primary rectal cancer. SMART for rectal cancer is well tolerated and effective in terms of tumor regression, especially if followed by delayed surgery.

TIRADS, SRE and SWE in INDETERMINATE thyroid nodule characterization: Which has better diagnostic performance?

PURPOSE: To assess Strain Ratio (SRE) and Shear Wave Elastography (SWE) accuracy alone and with TIRADS classification, for the risk stratification of indeterminate thyroid nodules. MATERIALS AND METHODS: 128 Patients with 128 indeterminate nodules candidates for thyroidectomy underwent preoperative staging neck ultrasound and were classified according to K-TIRADS score. After TIRADS evaluation, semi-quantitative (SRE) and quantitative (SWE expressed in kPa) elastosonography were performed and relative diagnostic performances, alone and in combination, were compared through ROC curves analysis. In order to maximize the SRE and SWE sensitivity and specificity, their cut-off values were calculated using the Liu test. Bonferroni test was used to evaluate statistically significant differences with a p value < 0.05. RESULTS: Sensitivity, specificity, PPV and NPV were, respectively, 71.4%, 82.4%, 62.5%, 87.5% for K-TIRADS baseline US, 85.7%, 94.1%, 85.7%, 94.1% for SRE and 57.1%, 79.4%, 53.3%, 81.8% for SWE (kPa expressed). SRE evaluation showed the best diagnostic accuracy compared to the SWE (kPa expressed) (p < 0.05) and to the K-TIRADS (p > 0.05). The association of SRE with conventional ultrasound with K-TIRADS score increased sensitivity (92.9% vs 71.4%) but decreased the specificity than conventional US alone (76.5% vs 82.4%). CONCLUSION: Strain Elastosonography can be associated with K-TIRADS US examination in the thyroid nodule characterization with indeterminate cytology; in fact, adding the SRE to K-TIRADS assessment significantly increases its sensitivity and negative predictive value. However, further multicenter studies on larger population are warranted.

Total fistulectomy, sphincteroplasty and closure of the residual cavity for trans-sphincteric perianal fistula in the elderly patient.

BACKGROUND: Perianal fistula is a complex and frequent disease. At present, no treatment nor technique has shown an absolute superiority in terms of efficacy and recurrence rate. The technique has to be chosen considering the balance between faecal continence preservation and disease eradication. Rarely concomitant perianal abscess and fistula are treated at the same time, and often time to complete recovery is long. AIMS: The aim of this study was to evaluate the possibility of treating the abscess and the fistula tract in one procedure with total fistulectomy, sphincteroplasty and an almost complete closure of the residual cavity, thus reducing the healing time in older patients. METHODS: A non-randomized single-centre series of 86 patients from 2007 to 2012 with low-medium trans-sphincteric perianal fistula (< 30% of external sphincter involvement) with or without synchronous perianal abscess were treated with total fistulectomy, sphincteroplasty and closure of the residual cavity technique. RESULTS: Success rate was 97.7% with a healing time of 4 weeks; overall morbidity was 16.2%; recurrence rate was 2.3%; no major alterations of continence were observed. DISCUSSION: Fistulectomy, sphincteroplasty and closure of the residual cavity are associated with a low rate of recurrence and good faecal continence preservation in older patients. This technique can be safely used even with a concomitant perianal abscess, with reduction in healing time and in the number of surgical procedures needed. CONCLUSIONS: Total fistulectomy with sphincteroplasty and partial closure of the residual cavity, as described, is a safe procedure but has to be performed by dedicated colorectal surgeons.

Magnetic resonance guided SBRT reirradiation in locally recurrent prostate cancer: a multicentric retrospective analysis.

AIMS: Reirradiation of prostate cancer (PC) local recurrences represents an emerging challenge for current radiotherapy. In this context, stereotactic body radiation therapy (SBRT) allows the delivery of high doses, with curative intent. Magnetic Resonance guided Radiation Therapy (MRgRT) has shown promising results in terms of safety, feasibility and efficacy of delivering SBRT thanks to the enhanced soft tissue contrast and the online adaptive workflow. This multicentric retrospective analysis evaluates the feasibility and efficacy of PC reirradiation, using a 0.35 T hybrid MR delivery unit. METHODS: Patients affected by local recurrences of PC and treated in five institutions between 2019 and 2022 were retrospectively collected. All patients had undergone previous Radiation Therapy (RT) in definitive or adjuvant setting. Re-treatment MRgSBRT was delivered with a total dose ranging from 25 to 40 Gy in 5 fractions. Toxicity according to CTCAE v 5.0 and treatment response were assessed at the end of the treatment and at follow-up. RESULTS: Eighteen patients were included in this analysis. All patients had previously undergone external beam radiation therapy (EBRT) up to a total dose of 59.36 to 80 Gy. Median cumulative biologically effective dose (BED) of SBRT re-treatment was 213,3 Gy (103,1-560), considering an α/ß of 1.5. Complete response was achieved in 4 patients (22.2%). No grade ≥ 2 acute genitourinary (GU) toxicity events were recorded, while gastrointestinal (GI) acute toxicity events occurred in 4 patients (22.2%). CONCLUSION: The low rates of acute toxicity of this experience encourages considering MRgSBRT a feasibile therapeutic approach for the treatment of clinically relapsed PC. Accurate gating of target volumes, the online adaptive planning workflow and the high definition of MRI treatment images allow delivering high doses to the PTV while efficiently sparing organs at risk (OARs).

Recommendation for the contouring of limbic system in patients receiving radiation treatment: A pictorial review for the everyday practice and education.

AIMS: The limbic circuit (LC) is devoted to linking emotion to behavior and cognition. The injury this system results in post-RT cognitive dysfunction. The aim of this study is to create the first radiation oncologist's practical MR-based contouring guide for the delineation of the LC for the everyday clinical practice and education. METHODS: An anonymized diagnostic 3.0 T T1-weighted BRAVO MRI sequence from a healthy patient with typical brain anatomy was used to delineate LC. For each structure key anatomical contours were completed by radiation oncologists, along with a neuro-radiologist to generate the final version of the LC atlas. RESULTS: a step-by-step MR-based atlas of LC was created. Key structures of the LC, such as, cingulate gyrus, fornix, septal region, mammillary bodies, thalamus and the hippocampal-amygdala formation were contoured. CONCLUSIONS: This article provides the recommendations for the first contouring atlas of LC in the setting of patients receiving RT and education.

Standard stapled transanal rectal resection versus stapled transanal rectal resection with one high-volume stapler to prevent complications in the elderly.

BACKGROUND: The causes of obstructed defecation syndrome (ODS) can actually be either functional or mechanical (primary or secondary deficit of the sensitivity, slow bowel transit, pelvic floor dyssynergia, internal and external rectal prolapse, recto-anal intussusceptions, anterior or posterior rectocele and pelvic prolapse of the bladder, uterus, bowel or sigma). The aim of our study was to evaluate the safety, efficacy and feasibility of stapled transanal rectal resection (STARR) procedure performed by a single or double stapler through clinical and functional outcomes for transanal stapled surgery. METHODS: From January 2016 to October 2017, ninety patients with ODS secondary to rectal prolapse, anal-rectal intussusception and anterior rectocele, that underwent to a STARR procedure were enrolled. Thirty of these underwent a STARR procedure with double circular stapler PPH-01 (Group A); 30 with single circular stapler CPH34HV with a purse string suture (Group B); and 30 with single circular stapler CPH34HV with a "parachute technique" (Group C). All patients were selected with clinical examination, Wexner score for fecal incontinence and ODS score for constipation. Patients also underwent a Defeco RMN for an anatomical and dynamic evaluation of the pelvic floor. RESULTS: No recurrence rates were observed in the three groups. The mean operative time was 46.3 minutes in group A; 34.5 minutes in group B; and 37.6 minutes in Group C. The volume of the resected specimen was 17 mL in group A; 15 mL in group B; and 16 mL in Group C. Complications were bleeding (3.3% in group A); fecal urgency (6.6% in group A, 10% in group B and 3.3% in group C); rectal hematoma (3.3% in group A). all symptoms significantly improved after the operation without differences between groups. CONCLUSIONS: The STARR technique performed with a single stapler CPH34HV is safe, faster and less expensive than the STARR performed by a double PPH01. Besides, with the parachute technique, it is possible to resect asymmetric prolapses.

External hemorrhoidal thrombosis in the elderly patients: conservative and surgical management.

BACKGROUND: External hemorrhoidal thrombosis is a common disease with an acute anal pain as the major symptom. It is astonishing the lack of studies which investigates the most effective treatment and there are not guidelines. Furthermore, nobody has ever evaluated this peculiar condition in an elderly population. METHODS: We have considered 87 patients aged >75 years who were visited and treated for this condition in our clinic, dividing them in three groups according the curative option chosen together with them after anamnesis and an interview: a conservative medical treatment (Group A), an immediate incision and evacuation of the thrombus (Group B) and the excision of hemorrhoid with the thrombus, with hemorrhoidectomy technique (Group C). The mean follow-up was 12.3 months. We analyzed immediate pain relief and time of remission of symptoms, bleeding, recurrences and major complications. RESULTS: The Group A presented a remission of symptoms in 11.8 days, Group B in 1.58 ad Group C in 7.8 days. The recurrence rate was very similar for the first two options (19.4% and 16.1%) and lower in the excision group (no recurrence during follow-up). Bleeding is the common adverse event observed with a high frequency in the immediate incision and evacuation of thrombus, less common in hemorrhoidectomy, that did not present major complication. Surgical option is often refused by elderly patient evaluating comorbidities in the fear of adverse events. CONCLUSIONS: The surgical treatment for EHT in elderly is safe and effective, but not the most common choice for fear of complications. Medical treatment or immediate incision of thrombus can be preferred and well accepted by elderly even if followed by a higher rate of recurrences.

OTSC® Proctology vs. fistulectomy and primary sphincter reconstruction as a treatment for low trans-sphincteric anal fistula in a randomized controlled pilot trial.

BACKGROUND: The aim of this study was to compare OTSC® proctology and fistulectomy with primary sphincter reconstruction results as treatment strategies for anorectal low trans-sphincteric fistula. METHODS: Between February 2012 and March 2013, patients affected by trans-sphincteric anal fistula were consecutively enrolled in the trial. Patients were randomized to receive fistulectomy with primary sphincter reconstruction or OTSC® Proctology. Demographic characteristics, comorbodities, previous anorectal treatments, and recurrent fistula data were acquired. Postoperative therapy data and pain and Wexner scores (30 and 60 dd) were acquired during follow-up. Furthermore, patients were contacted by telephone after six months, and were visited both one year and three years after surgery. RESULTS: Thirty consecutive patients were included in the study. 15 patients underwent the OTSC® Proctology procedure and 15 underwent the standard fistulectomy. The success rate was 93.3% in the OTSC group. The mean postoperative stay was 1.3 days in the OTSC® patients and 3.6 days in the fistulectomy group patients. The mean medications required for complete healing was 3.2 in the OTSC group and 8.9 in the FIPS group. CONCLUSIONS: Our results suggest that OTSC® Proctology is an effective and safe treatment in achieving permanent closure of the internal fistula opening in selected patients, with excellent results in terms of pain, postoperative incontinence, healing time, and days of hospitalization.

Are we ready for a paradigm shift from high-dose conventional to moderate hypofractionated radiotherapy in intermediate-high risk prostate cancer? A systematic review of randomized controlled trials with trial sequential analysis.

AIM: to evaluate efficacy and late toxicity of moderate hypofractionated (HFRT) over high-dose (>76 Gy) conventional radiotherapy (CRT) in a non-inferiority perspective. METHODS: Randomized controlled trials (RCTs) were included. HFRT regimens were deemed non-inferior to high-dose CRT if the computed CI for the overall RR did not exceed the non-inferiority margin of 7%. RESULTS: When the prespecified margin, corresponding to a critical RR of 0.930 for CCS, OS and BFS, was used all efficacy outcomes satisfied the criteria for the non-inferiority analysis indicating the non-inferiority of HFRT regimens over high-dose CRT in the medium term period. Differently, the evidence concerning the late toxicity was inconclusive. CONCLUSIONS: Noninferiority analysis indicates that moderate HFRT regimes are non-inferior over high-dose CRT in the medium-term. Inconclusive is the evidence for the late toxicity. Longer follow-up will provide a more clear answer concerning the non-inferiority of HFRT regimens in the long-term period.

Use of the circular compression stapler and circular mechanical stapler in the end-to-side transanal colorectal anastomosis after left colon and rectal resections A single center experience.

AIM: The aim of our study was to compare the efficacy of the circular compression stapler and the circular mechanical stapler in transanal colorectal anastomosis after left colectomy or anterior rectal resection. MATERIALS AND METHODS: We performed a retrospective analysis of 10 patients with disease of the, sigmoid colon or rectum (carcinoma or diverticular disease) who underwent left colectomy or anterior rectal resection with end-to-side transanal colorectal anastomosis. A follow-up was planned for all patients at 1, 3 and 6 months after surgery and the anastomosis was evaluated by colonoscopy at 1 year. RESULTS: In all patients an end-to-side transanal colorectal anastomosis was performed using a circular compression stapler (CCS group) or circular mechanical staplers with titanium staples (CMS group). The mean distance of the anastomosis from the anal margin was 6.4 ± 1.5 cm in the CCS group and 18.2 ± 11.2 cm in the CMS group. All patients in the CCS group expelled the ring after a mean time of 8.2 postoperative days. At 12 months colonoscopy revealed that all CCS patients had a satisfactory anastomosis with mean size of the colic lumen at the level of anastomotic line of 26.3 mm. CONCLUSIONS: In our experience the circular compression stapler a valuable alternative to the circular mechanical stapler for the creation of transanal colorectal anastomosis, in line with the relevant literature. KEY WORDS: Anastomotic leakage, Anastomotic stenosis, Circular compression stapler, Circular mechanical stapler, Transanal colorectal anastomosis.