Robotic versus open total mesorectal excision for rectal cancer: comparative study of short and long-term outcomes.

BACKGROUND: Despite the several series in which the short-term outcomes of robotic-assisted surgery were investigated, data concerning the long-term outcomes are still scarce. METHODS: The prospectively collected records of 65 consecutive patients with extraperitoneal rectal cancer who underwent robotic total mesorectal excision (RTME) were compared with those of 109 consecutive patients treated with open surgery (OTME). Patient characteristics, pathological findings, local and systemic recurrence rates and 5-year survival rates were compared. RESULTS: There were no statistically significant differences in postoperative complications, reoperation and 30-day mortality. There were significant differences comparing groups: number of lymph nodes harvested (RTME: 20.1 vs. OTME: 14.1, P < 0.001), estimated blood loss (RTME: 0 vs. OTME: 150 ml, P = 0.003), operation time (RTME: 299.0 vs. OTME: 207.5 min, P < 0.001) and length of postoperative stay (RTME: 6 vs. OTME: 9 days, P < 0.001). The rate of circumferential resection margin involvement and distal resection margin were not statistically different between groups. There were no statistically significant differences at the 5-year follow-up: overall survival, disease-free survival and cancer-specific survival. The cumulative local recurrence rate was statistically lower in the robotic group (RTME: 3.4% vs. OTME: 16.1%, P = 0.024). CONCLUSION: RTME showed a significant reduction in local recurrence rate and a higher, although not statistically significant, long-term cancer-specific survival with respect to OTME. Prospective randomized studies are needed to confirm or deny significantly better local control rates with robotic surgery.

Impact on survival of the number of lymph nodes removed in patients with node-negative gastric cancer submitted to extended lymph node dissection.

PURPOSE: This study was designed to establish whether the number of lymph nodes removed has an effect on prognosis in patients with node-negative gastric cancer. PATIENTS AND METHODS: We retrospectively analysed data of 114 consecutive patients who underwent gastrectomy and extended lymph node dissection for node-negative adenocarcinoma of the stomach between 2000 and 2005. Standard survival methods and restricted cubic spline multivariable Cox regression models were applied. RESULTS: Median age was 63 years and 67 patients out of 114 (59%) were males. Median number of dissected LNs was 22 (range 2-73). Median follow-up was 76 months. Patients who had ≤15 nodes removed had significantly worse distant disease-free survival, disease-free survival and overall survival at multivariable analysis than other patients. The results did not change when pT1 and pT2-3 cancer patients were analysed separately. The risk of distant metastases decreased as the number of dissected lymph nodes increased (>15). CONCLUSIONS: More extended lymph node resection offered survival benefit even in the subgroup of patients with early stage disease. Lymphadenectomy involving more than 15 lymph nodes should be performed for the treatment of node-negative gastric cancer. SYNOPSIS: The impact on survival of the number of lymph nodes removed in patients with node-negative gastric cancer has not been established. This study suggests that more extended lymph node resection offers protection, as patients who had ≤15 nodes removed had significantly worse disease-free survival and overall survival at multivariate analysis than patients in whom >15 nodes were removed.

Use of totally implantable central venous access ports for high-dose chemotherapy and peripheral blood stem cell transplantation: results of a monocentre series of 376 patients.

BACKGROUND: The complication rate of central venous totally implantable access ports (TIAP), used for high-dose chemotherapy with autologous stem cell transplantation support, has not been fully investigated to date, due to the almost exclusive use of externalised, tunnelled devices in this clinical setting. PATIENTS AND METHODS: During a 66-month period (from 1 January 1997 to 30 June 2002), 376 patients suffering from breast cancer, ovarian cancer, lymphoma or multiple myeloma were treated with high-dose chemotherapy and autologous stem cell transplantation at the European Institute of Oncology (Milan, Italy). A single type of port was used, constructed from titanium and silicone rubber, connected to a 7.8 F polyurethane catheter (Port-A-Cath; SIMS Deltec, Inc., St Paul, MN, USA) inserted into the subclavian vein. They were followed prospectively for device-related complications until the device was removed, the patient died or the study was closed (30 June 2002). RESULTS: No TIAP-related deaths were observed in this series. Seven pneumothoraxes (1.8%) occurred as a complication of TIAP placement, one patient only (0.2%) requiring a tube thoracostomy. Port pocket infection occurred twice in this series (0.53%, 0.01 episodes/1000 days of use), whereas three patients suffered from port-related bacteraemia (0.8%, 0.016/1000 days of use). Infections were successfully treated with antibiotics; all three cases had the ports removed at programme completion. Four cases of deep vein thrombosis were detected (1.06%, 0.022/1000 days of use); low molecular weight heparin was given, followed by oral anticoagulants. Finally, one case of extravasation occurred (0.26%, 0.005/1000 days of use), requiring port removal and local medical therapy. CONCLUSIONS: The use of TIAPs has resulted in a safe and effective option for high-dose chemotherapy deliverance and stem cell transplantation, in spite of inducing severe neutropenia and increasing the risk of sepsis in this category of oncology patient.

Valved central venous catheter connected to subcutaneous port: A multicenter phase IV study based on a cohort of 50 oncology patients.

PURPOSE: Since technical aspects and clinical features of central venous valved catheters are far from being completely understood, a multinational group of investigators has decided to assess a new distally-valved catheter connected to a port, in the clinical setting of oncology patients undergoing chemotherapy, in an attempt to verify its safety and viability, while also investigating its practical features. METHODS: Our project was structured as a phase IV multicenter study. Hospitalized adults (ages 18-80 years) who had solid tumors and were candidate for intravenous chemotherapy met the criteria to enter the study. One single type of port was used (made of titanium, plastic and silicone) connected to a silicone, distally valved catheter (as manufactured by B. Braun Aesculap). A case report form was provided for each treated case; all relevant data regarding implantation and follow-up were entered into the form, mailed to a coordinating center (G. Chevillon, B. Braun Medical, France) and stored in a software database for statistical analysis. RESULTS: 50 patients (from 6 participating centers) were included in this study. No major complications occurred at insertion. The most frequent clinical problem during follow-up was inability to draw blood samples (9% during the first chemotherapy cycle; 8% after the second cycle); blood obtained from the device was defined 'unsuitable for hematology test' in 9% of the cases at first chemotherapy cycle and in 23% of the cases after the second cycle. No catheter obstruction occurred. CONCLUSION: The distally valved catheter port tested in this study was reliable, safe and practical for long-term treatment of an oncology patients' population undergoing chemotherapy. As most other reports and clinical trials dealing with other types of distally valved catheters pointed out, inability to draw viable blood samples (so called withdrawal occlusion) is a major concern in their clinical use. Mechanisms underlying this technical problem are still unclear.

Treatment of pneumothorax as a complication of long-term central venous port placement in oncology patients. An observational study.

Background and purpose.In percutaneous placement of central venous catheters an inadvertent, direct lesion of the lung parenchyma can occur. This is a cause of iatrogenic pneumothorax, whose incidence is approximately 1 to 4%, largely dependent on the experience of the operator, the site of venipuncture and proba-bly the technique employed. Initial treatment currently ranges from observation alone to formal tube-thoracostomy. In an attempt to define the best initial treatment, if any, we reviewed our personal series and contributions from the literature. As a result we have produced a flow-chart proposing a rational treatment of this frequent complication. Patients and Methods.One thousand four hundred twenty-one ports were placed in patients at the Department of Surgery of the European Institute of Oncology in Milan through an infraclavicular standardized percutaneous subclavian approach. They were placed during the 60-month period from January 1, 1996 to December 31, 2000 for long-term chemotherapy treatment of solid tumours. Chest upright X-rays were obtained post-operatively in all cases to check the correct position of the catheter tip and the presence of pneumothorax. Results.Twenty-two patients out of 1421 (1.54%) experienced a radiologically-proven pneumothorax, ranging from 5 to 70% of the affected pleural space. Sixteen patients out of 22 (72.7%) with minor portions of affected pleural space received simple observation. In these patients the most common finding was an uncomplicated tachycardia (more than 100 beats/min); 8 of them did not complain of any symptoms. Six patients (27.2%) un-derwent an additional procedure (3 tube-thoracostomies and 3 aspirations of the pleural space), claiming symptoms of chest pain and various degrees of dyspnea. Tube thoracostomy was mainly adopted at the beginning of our experience, and in patients with a severe degree of pleural involvement (55 to 70% of the pleural space). Aspiration, instead, was used more recently and in patients with varying degrees of pleural space involved, ranging from 40 to 60%. Conclusions.Looking at our own series and literature data, patients with iatrogenic pneumothorax following central venous cannulation who do not have a severe underlying pulmonary disease can be reassured, at the time of diagnosis, that surgery is usually unnecessary and tube thoracostomy is rarely needed. Simple aspiration of the pleural air by means of a central venous catheter inserted percutaneously into the pleural space under local anesthesia should be considered, even if the amount of affected pleural space is more than 50%, before opting for a formal tube-thoracostomy using small-bore tubes.

Flexible sigmoidoscopy as a colorectal cancer screening test in the general population: recruitment phase results of a randomized controlled trial in Lombardia, Italy.

UNLABELLED: A two arm multicentre randomized controlled trial is in progress to evaluate the efficacy of flexible sigmoidoscopy (FS) as a screening test for colorectal cancer in the general population. AIMS: To determine the acceptance rate and feasibility of FS as a colorectal cancer screening test in average-risk asymptomatic volunteers. Average-risk, asymptomatic subjects, aged 55-64 years and assisted by 244 general practitioners (GPs) in Lombardy, Italy, were invited by postal questionnaire (PQ) to enter a study for the prevention of colorectal cancer and asked to indicate their interest in, and willingness to undergo, screening: those responding positively were randomized to the intervention or control arms. GPs were trained in colorectal cancer screening and proposed free FS to their patients randomized to the intervention arm. All sigmoidoscopies were performed by experienced endoscopists. Small polyps were removed at FS. Colonoscopy was indicated for high risk polyps (size more than 5 mm, more than two adenomas, villous histology, severe dysplasia or malignancy). 40,945 subjects were invited. 667 PQs were returned undelivered due to postal failure. 7,892 (19.59%) subjects responded, 2,116 of whom (26.81%) were not included, presenting 1 or more exclusion criteria. We randomized 5,778 volunteers and performed 1,582 sigmoidoscopies out of 2,885 subjects in the intervention arm (54.84% acceptance rate). Although the screening procedure had a good attendance rate in the intervention group, involvement of the people invited was lower than expected. Future FS screening programmes will require a keener focus on recruitment strategies, mainly with participation of GPs.

Complications and long-term outcome of 80 oncology patients undergoing needle catheter jejunostomy placement for early postoperative enteral feeding.

Some findings suggest that needle catheter jejunostomy (NCJ) is associated with a significant rate of potentially dangerous complications. The purpose of this study was to prospectively evaluate the rate and type of early and late complications associated with NCJ in patients with surgical treatment of upper gastrointestinal malignancy. Eighty patients underwent NCJ implant at the end of their scheduled surgical procedure. Enteral nutrition programme was started on postoperative day 1 in the surgical ICU. NCJ was always removed in the outpatient clinic after hospital discharge. One case of tube blockage has been observed as single short-term complication in this series. No long-term complications have been detected after a mean follow-up of 12 months. Routine use of NCJ in malnourished patients undergoing major surgical procedures on upper gastrointestinal tract is safe and effective.

Catheter rupture and distal embolisation: a rare complication of central venous ports.

Central venous access devices placed through a percutaneous subclavian approach may be compressed by neighbouring bony structures, leading to biomaterial fatigue, catheter fracture at the compression site, and possible embolisation of distal fragment into the central veins. The aim of this paper is to review the experience of the authors, including more than 1300 subclavian port placements, carried out during a five-year period, discussing possible causes and therapeutic options of this rare complication. Nine patients out of 1320 (0.68%) experienced this complication during the five-year period of this study. Two patients only showed a retrospective radiologic evidence of the 'pinch-off sign' (e.g. initial compression of the catheter at the costo-clavicular junction). No patients had symptoms from the embolised catheter fragment; the most frequent symptom (8 out of 9 cases) was a painful swelling around the port area during infusion, related to the extravasation of medications or fluids into the subcutaneous tissue. The site of embolised segment varied from azygos vein to right pulmonary artery; however, these findings did not affect the outcome, and all the embolised fragments were successfully retrieved through a transfemoral approach using a radiologic interventional technique. No fatality occurred. The catheter fracture and embolisation of the distal fragment are a well-known complication of subclavian central venous long-term cannulation, whose estimated overall incidence is 0.5-1%. Diagnosis is usually based on the radiologic appearance of the catheter compression (so called 'pinch-off sign'), which is far from being constant; a clinical suspicion can derive from intermittent malfunction, which claims differential diagnosis with the pres-ence of a fibrin sleeve around the tip of the catheter. Once diagnosed, the treatment is always an interventional radiologic approach, which has a very high success rate. When it fails, the possibility to leave the fragment embolised in the central veins, heart or pulmonary arteries, should be considered, being the thoracotomy and open catheter retraction questionable, at present time, in patients who have no symptoms and limited life-expectancy.