Organ-saving surgery for rectal cancer after neoadjuvant chemoradiation: Analysis of failures and long-term results.

BACKGROUND: To analyze long-term results and risk of relapse in the clinical TNM stages II and III, mid-low rectal cancer patients (RC pts), treated with transanal local excision (LE) after major response to neoadjuvant chemoradiation (n-CRT). METHODS: Thirty-two out of 345 extraperitoneal cT3-4 or N+ RC pts (9.3%) underwent LE. INCLUSION CRITERIA: extraperitoneal RC, adenocarcinoma, ECOG Performance Status ≤2. Pts with distant metastases were excluded. RESULTS: All pts showed histologically clear margins of resection and 81.2% were restaged ypT0/mic/1. Nine out of 32 (28.1%) pts relapsed: 7 (21.8%) showed a local recurrence, of which 5 (15.6%) at the endorectal suture, 1 (3.1%) pelvic and 1 (3.1%) mesorectal. Two pts (6.2%) relapsed distantly. Among the pT0/1, 11.5% relapsed vs 100% of the pT2 and pT4 ones. The six pts relapsing locally or in the mesorectal fat underwent a salvage total mesorectal excision surgery. The old patient with pelvic recurrence relapsed after 108 months and underwent a re-irradiation; the two pts with distant metastases were treated with chemotherapy followed by radical surgery. CONCLUSIONS: Presently combined approach seems a valid option in major responders, confirming its potential curative impact in the ypT0/mic/1 pts. A strict selection of pts is basic to obtain favourable results.

Drain after elective laparoscopic cholecystectomy. A randomized multicentre controlled trial.

BACKGROUND: Routine drainage after laparoscopic cholecystectomy is still debatable. The present study was designed to assess the role of drains in laparoscopic cholecystectomy performed for nonacutely inflamed gallbladder. METHODS: After laparoscopic gallbladder removal, 53 patients were randomized to have a suction drain positioned in the subhepatic space and 53 patients to have a sham drain. The primary outcome measure was the presence of subhepatic fluid collection at abdominal ultrasonography, performed 24 h after surgery. Secondary outcome measures were postoperative abdominal and shoulder tip pain, use of analgesics, nausea, vomiting, and morbidity. RESULTS: Subhepatic fluid collection was not found in 45 patients (84.9 %) in group A and in 46 patients (86.8 %) in group B (difference 1.9 (95 % confidence interval -11.37 to 15.17; P = 0.998). No significant difference in visual analogue scale scores with respect to abdominal and shoulder pain, use of parenteral ketorolac, nausea, and vomiting were found in either group. Two (1.9 %) significant hemorrhagic events occurred postoperatively. Wound infection was observed in three patients (5.7 %) in group A and two patients (3.8 %) in group B (difference 1.9 (95 % CI -6.19 to 9.99; P = 0.997). CONCLUSIONS: The present study was unable to prove that the drain was useful in elective, uncomplicated LC.

Robotic Heller-Dor procedure for oesophageal achalasia: Fluorescence-guided intraoperative assessment of myotomy. A retrospective single-centre experience.

BACKGROUND: The robotic Heller-Dor (RHD) procedure for oesophageal achalasia (EA) is safe and effective. We aim to evaluate the intraoperative use of fluorescence imaging, as an alternative means to intraoperative endoscopy, to assess myotomy at the end of the procedure. METHODS: Thirty-four patients affected with EA underwent RHD. The myotomy was assessed intraoperatively by endoscopy in group A (17 patients), and by fluorescence imaging in group B (17 patients). Perioperative and long-term results were compared. RESULTS: In group A, one mucosal tear was identified during intraoperative endoscopy. In group B, indocyanine green (ICG) helped identify residual muscle fibres in three cases. No perforation of the oesophageal mucosa occurred in group B. CONCLUSIONS: Fluorescence-imaging improved the identification of residual muscle fibres and made it possible to verify the integrity of the mucosa without the use of intraoperative endoscopy. A significant reduction in operative times has been related to the use of this technique.

The role of telemedicine in the postoperative home monitoring after robotic colo-rectal cancer surgery: a preliminary single center experience.

The telemedicine studies, takes care and prevents diseases at distance basing on the interaction among physicians and patients remotely. Few data are available on its application to early postoperative after surgery. The endpoints of our preliminary experience were the detection, as primary, of feasibility and safety of home telemonitoring after robotic colo-rectal resection and, as secondary, perception and satisfaction of the patients. From December 2019 to March 2020, at the Division of Robotic Surgery of San Giovanni Hospital of Rome, 20 of 29 colorectal cancer patients, submitted to Robotic resection, were prospectively included in a program of postoperative home telemonitoring. Telemonitoring was considered feasible if at least 75% of data were available and safe if morbidity ≤ II by Clavien-Dindo classification. Perception and patients' satisfaction were evaluated through a dedicated questionnaire. Out of 20 patients, the median age was 68 years, overall postoperative morbidity was 30%, all events classified Clavien-Dindo Grade I or II. Only 2 patients were corresponded to surgical consult without readmission during home telemonitoring. Compliance of patients was > 80%, overall grade of satisfaction was very high: 4.2 as median (range 0-5). In this preliminary study, the procedures of postoperative home telemonitoring were feasible and safe and high rate of patients' satisfaction was observed. The telemedicine could enhance the role of robotic technique in decrease the hospital stay and improving postoperative recovery after surgery. Further structured prospective trial are needed to validate the routine application of telemedicine in healthcare.

ICG-NIR-guided lymph node dissection during robotic subtotal gastrectomy for gastric cancer. A single-centre experience.

BACKGROUND: Near-infrared (NIR) fluorescence imaging with indocyanine green (ICG) allows intraoperative visualisation of the lymph nodes (LNs) draining the tumour. METHODS: We included in our study 20 patients who underwent robotic subtotal gastrectomy + D2 lymphadenectomy for gastric cancer. In 10 cases, intraoperative ICG-guided lymphography has been used (Group A). We compared the number of LNs retrieved with the use of NIR imaging and the number of LNs retrieved without the use of this technique (Group B, historical group). RESULTS: No complications related to ICG injection or near-infrared imaging were observed. The mean number of overall LNs retrieved was significantly greater in Group A than in group B (40 vs. 24). No statistically significant difference in operative time was observed. CONCLUSIONS: ICG-guided fluorescent lymphography can help in performing a more accurate locoregional lymphadenectomy during robotic subtotal gastrectomy for gastric cancer. This technique represents a precious contribution to gastric cancer surgery.

Safety profile and oncological outcomes of gastric gastrointestinal stromal tumors (GISTs) robotic resection: Single center experience.

BACKGROUND: Although usefulness of robot assisted surgery has been largely reported and accepted, robot assisted gastrointestinal stromal tumor (GIST) treatment is rare. Hence, the aim of this study is to report a single center evaluation on gastric GIST's robotic resection. METHODS: Six patients were analyzed focusing on safe (conversion/complications rate, hospital stay), oncological (margin resection, recurrence rate), and feasible (operative time, technical tip, and tricks) profile of robotic-assisted GIST surgery. RESULTS: The mean operative time and hospital stay was 173 ± 39 minutes and 3 ± 1 days, respectively. The conversion rate (to open or laparoscopy) was nil, and no intra and postoperative (mean follow-up 12 months) complications were registered. In all cases, the resections were classified as R0. CONCLUSIONS: This study supports the usefulness of robotic-assisted surgery, as the anatomical hand-sewn reconstruction might avoid the stomach distortion, and the oncological (100% R0) and safety profile outcomes encourage its use. However, further studies with larger sample size are recommended to confirm the outcomes of this study.

Tumor Regression Grade After Neoadjuvant Chemoradiation and Surgery for Low Rectal Cancer Evaluated by Multiple Correspondence Analysis: Ten Years as Minimum Follow-up.

BACKGROUND: The role of Mandard's tumor regression grade (TRG) classification is still controversial in defining the prognostic role of patients who have undergone neoadjuvant chemoradiation (CRT) and total mesorectal excision. The present study evaluated multiple correspondence analysis (MCA) as a tool to better cluster variables, including TRG, for a homogeneous prognosis. PATIENTS AND METHODS: A total of 174 patients with a minimum follow-up period of 10 years were stratified into 2 groups: group A (TRG 1-3) and group B (TRG 4-5) using Mandard's classification. Overall survival and disease-free survival were analyzed using univariate and multivariate analysis. Subsequently, MCA was used to analyze TRG plus the other prognostic variables. RESULTS: The overall response to CRT was 55.7%, including 13.2% with a pathologic complete response. TRG group A correlated strictly with pN status (P = .0001) and had better overall and disease-free survival than group B (85.1% and 75.6% vs. 71.1% and 67.3%; P = .06 and P = .04, respectively). The TRG 3 subset (about one third of our series) showed prognostically heterogeneous behavior. In addition to multivariate analysis, MCA separated TRG 1 and TRG 2 versus TRG 4 and TRG 5 well and also allocated TRG 3 patients close to the unfavorable prognostic variables. CONCLUSION: TRG classification should be used in all pathologic reports after neoadjuvant CRT and radical surgery to enrich the prognostic profile of patients with an intermediate risk of relapse and to identify patients eligible for more conservative treatment. Thus, MCA could provide added value.

Is minilaparoscopic inguinal hernia repair feasible? A preliminary experience.

INTRODUCTION: Laparoscopy has rapidly emerged as the preferred surgical approach to a number of different diseases because it allows for a correct diagnosis and proper treatment. It seems to be moving toward the use of mini-instruments (5 mm or less in diameter). The aim of this paper is to illustrate retrospectively the results of an initial experience of minilaparoscopic transabdominal preperitoneal (miniTAPP) repair of groin hernia defects performed at two institutions. MATERIALS AND METHODS: Between February 2000 and December 2003, a total of 303 patients (mean age, 45 years) underwent a miniTAPP procedure: 213 patients (70.2%) were operated on bilaterally and 90 (28.7%) for a unilateral defect, with a total of 516 hernia defects repaired. The primary endpoint was the feasibility rate for miniTAPP. The secondary endpoint was the incidence of mini-TAPP-related complications. RESULTS: No conversions to laparoscopy or an anterior open approach were required. There were no major complications, while minor complications ranged as high as 0.3%. CONCLUSION: While limited by its retrospective design, the present study indicates that the minilaparoscopic approach to groin hernia repair is safe and effective, making miniTAPP a challenging alternative to laparoscopy in the approach to groin hernia repair.

Hepatic arterial infusion (HAI) of cisplatin and systemic fluorouracil in the treatment of unresectable colorectal liver metastases.

BACKGROUND: Only 5-10% of colorectal cancer patients (pts) with liver metastases are eligible for surgical resection. Regional and systemic chemotherapy represents the best therapeutic options for unresectable metastases. MATERIALS AND METHODS: In a randomized phase II trial 123 pts were enrolled with a minimum follow-up of 3 years. In Arm A 58 pts were submitted to intraarterial continuous infusion of cisplatin (CDDP), 24 mg/m2/day, while the other 65 were included in Arm B (bolus of CDDP, 24 mg/m2/day). All the pts were also given i.v. escalating doses of fluorouracil. Response was evaluated after a minimum of 3 cycles. RESULTS: Toxicity > or = G3 was lower in Arm B. The objective response rate was 52% in all the series, the complete responses being 17.3% (17.6% vs. 17% in Arms A and B, respectively). The overall median survival was 18 months rising to 28 months in the responders. CONCLUSION: CDDP HAI provided similar results as FUdR in terms of response to treatment. Moreover, long-term survivors were unexpectedly observed.

Decrease of survivin, p53 and Bcl-2 expression in chemorefractory colorectal liver metastases may be predictive of radiosensivity radiosensivity after radioembolization with yttrium-90 resin microspheres.

In a prospective multicenter phase II trial of radioembolization with yttrium-90 ((90)Y-RE) in chemorefractory liver-dominant metastatic colorectal cancer (mCRC), we showed that median survival was 12.6 months (95% CI 7.0-18.3) with 48% of 50 patients achieving disease control. In this extension retrospective study, we analyzed whether a panel of biomarkers, known to be associated to an adverse clinical outcome, underwent variations in CRC liver metastases pre and post (90)Y-RE.Of the 50 patients included in the study, 29 pre-(90)Y-RE therapy and 15 post-(90)Y-RE had liver biopsy specimens available. In these series we investigated survivin, p53, Bcl-2 and Ki-67 expression pre- and post-(90)Y-RE by immuhistochemistry (IHC). Our findings evidenced a decrease of survivin (77% vs 33%), p53 (93% vs 73%), Bcl-2 (37% vs 26%) expression as well as of Ki-67 proliferation index (62.5% vs 40%) on liver biopsies collected post-(90)Y-RE as compared to pre-(90)Y-RE. In the subset of 13 matched liver metastases we further confirmed the reduction of survivin (92.3% vs 53.8%; p = 0.06), p53 (100% vs 69.2%; p = 0.05) and Bcl-2 (69.2% vs 53.8%; p = 0.05) expression post-(90)Y-RE. This biomarker modulation was accompanied by morphological changes as steatohepatitis, hepatocyte necrosis, collagen deposition, proliferating and/or bile duct ectasia, focal sinusoidal dilatation and fibrosis.Although our analysis was conducted in a very limited number cases, these changes appear strictly related to the response to (90)Y-RE therapy and may deserve further investigation on a larger series of patients.

Evaluation of relapse-free survival in T3N0 colon cancer: the role of chemotherapy, a multicentric retrospective analysis.

BACKGROUND: Adjuvant chemotherapy (AC) in Stage II Colon Cancer (CC) is still under debate. Choice should be based on patients and disease characteristics. According to guidelines AC should be considered in high-risk T3N0 patients. No data are available for better option in low-risk patients. The aim of the study is to retrospectively evaluate relapse-free survival (RFS) and disease-free survival (DFS) according to treatment received in T3N0 CC. METHODS: RFS and DFS are evaluated with Kaplan-Meier method. Multivariate Cox proportional hazard model was developed using stepwise regression, enter limit and remove limit were p = 0.10 and p = 0.15, respectively. RESULTS: 834 patients with T3N0 CC were recruited. Median age was 69 (29-93), M/F 463/371, 335 low-risk patients (40.2%), 387 high-risk (46.4%), 112 unknown (13.4%); 127 (15.2%) patients showed symptoms at diagnosis. Median sampled lymph nodes were 15 (1-76); 353 (42.3%) patients were treated with AC. Median follow up was 5 years (range 3-24). The 5-years RFS was 78.4% and the 5-years DFS was 76.7%. At multivariate analysis symptoms, lymph nodes, and adjuvant chemotherapy were prognostic factors for RFS. AC is prognostic factor for all endpoints. In low-risk group 5-years RFS was 87.3% in treated patients and 74.7% in non-treated patients (p 0.03); in high-risk group was respectively 82.7% and 71.4% (p 0.005). CONCLUSIONS: Data confirmed the role of known prognostic factors and suggest the relevance of adjuvant chemotherapy also in low-risk stage II T3N0 CC patients. However, the highest risk in low-risk subgroup should be identified to be submitted to AC.

Integration of radioembolisation into multimodal treatment of liver-dominant metastatic colorectal cancer.

INTRODUCTION: Radioembolisation (selective internal radiation therapy; SIRT), as part of a continuous strategy contributed to the improvement in response rates and median survival for unresectable metastatic colorectal cancer. Therefore, the role of SIRT in the different stages of treatment plan was investigated in this review. AREAS COVERED: After a brief description of the principles of SIRT, the review focused on the clinical evidences of published trials on the current experience of radioembolisation and its role in both salvage setting and earlier lines of chemotherapy. EXPERT OPINION: Evidence from Phase I studies and small Phase II/III randomised controlled trials has provided an early signal of the safety and improved overall survival, which can be achieved with radioembolisation and chemotherapy compared with chemotherapy (alone), due to an improved liver control. In the salvage setting, interesting results were observed in term of response, toxicity and median overall survival. Until the results of these early-line randomised trials will be available, radioembolisation could be considered either alone or combined with an appropriate chemotherapy regimen following failure of first- or second-line therapy.

Survival of hereditary non-polyposis colorectal cancer patients compared with sporadic colorectal cancer patients.

BACKGROUND: Patients with hereditary non-poliposys colorectal cancer (HNPCC) have better prognosis than sporadic colorectal cancer (CRC). Aim of our retrospective study was to compare the overall survival between sporadic CRC and HNPCC patients. METHODS: We analyzed a cohort of 40 (25 males and 15 females) HNPCC cases with a hospital consecutive series of 573 (312 males and 261 females) sporadic CRC observed during the period 1970-1993. In 15 HNPCC patients we performed mutational analysis for microsatellite instability. Survival rates were calculated by Kaplan-Meier method and compared with log rank test. RESULTS: The median age at diagnosis of the primary CRC was 46.8 years in the HNPCC series versus 61 years in sporadic CRC group. In HNPCC group 85% had a right cancer location, vs. 57% in the sporadic cancer group. In the sporadic cancer group 61.6% were early-stages cancer (Dukes' A and B) vs. 70% in the HNPCC group (p = ns). The crude 5-years cumulative survival after the primary CRC was 94.2% in HNPCC patients vs. 75.3% in sporadic cancer patients (p < 0.0001). CONCLUSION: Our results show that overall survival of colorectal cancer in patients with HNPCC is better than sporadic CRC patients. The different outcome probably relates to the specific tumorigenesis involving DNA mismatch repair dysfunction.

Prognostic value of soluble P-selectin levels in colorectal cancer.

Measurement of soluble (s) P-selectin levels has been proposed as a diagnostic tool for monitoring the clinical course of human neoplasms. Thus, our study was aimed at analyzing the role of sP-selectin in association with clinicopathological variables in 181 patients with primary (n =149) or metastatic (n = 32) colorectal cancer (CRC), 34 patients with benign diseases and 181 control subjects. The results obtained showed that sP-selectin levels were higher in patients with CRC compared either to patients with benign disease (p = 0.006) or controls (p = 0.003). No differences were observed between the latter and patients with benign diseases. Increased median sP-selectin levels were significantly associated with the presence of distant metastasis (68.2 ng/ml vs. 48.6 ng/ml, p = 0.002). Of interest, carcinoembryonic antigen (CEA) levels were independently associated to sP-selectin (regression coefficient = 0.28, p < 0.002). Cox's proportional hazards survival analysis of primary CRC patients demonstrated that beside the stage of disease sP-selectin levels had an independent prognostic role in predicting recurrent disease (HR = 2.22, p = 0.019) and mortality from CRC (HR = 3.44, p= 0.017). These results suggest that measurement of plasma sP-selectin might represent a prognostic indicator in the management of patients with CRC.