Yoshihisa Saida

Long-term prognosis of preoperative "bridge to surgery" expandable metallic stent insertion for obstructive colorectal cancer: comparison with emergency operation.

PURPOSE Expandable metallic stent endoprosthesis for preoperative “bridge to surgery” treatment of obstructive colorectal cancer has been broadly, clinically used with good short-term results. Stent insertion for malignant tumor, however, is controversial because of the increased risk of metastasis, invasion, and advancement of the cancer. We, first in the world, evaluated the long-term prognosis of expandable metallic stent insertion compared with emergency surgery without expandable metallic stent. METHODS Forty emergency operations (1986–1996) and 44 expandable metallic stent insertions (1993–2001) were retrospectively compared by history, duration, morbidity, and cumulative survival rate. RESULTS There was no significant difference in age or lesion between the two groups. Postoperative complications were significantly less frequent in the expandable metallic stent group: wound infection was 14 vs. 2 percent; leakage following to anastomosis was 11 vs. 3 percent. Long-term prognosis did not significantly differ: three-year overall survival rate was 50 vs. 48 percent; five-year survival rate was 44 vs. 40 percent in the emergency operation and expandable metallic stent groups, respectively. CONCLUSION Because preoperative expandable metallic stent insertion for obstructive colorectal cancer had good postoperative results and no disadvantages in long-term prognosis, this procedure should be used in preoperative treatments of obstructive colorectal cancer.

Stent endoprosthesis for obstructing colorectal cancers.

PURPOSE: Purpose of this study was to assess stent endoprosthesis for colorectal cancer (SECC) as an adjuvant to operative preparation in patients with obstructing colorectal cancers. METHODS: A self-expanding stainless steel stent was inserted in 15 patients with obstructing colorectal cancers under colonoscopic observation and fluoroscopic control. Following successful SECC, the colon was mechanically prepared using polyethylene glycol. Definitive surgical treatment then was undertaken. RESULTS: All 12 patients in whom the stent had been successfully placed recovered intestinal transit and tolerated mechanical preparation. A satisfactory preparation was confirmed during the operation. Two perforations and one dislocation were encountered. CONCLUSION: SECC is a new method for operative preparation of patients with obstructing colorectal cancers, which may reduce morbidity and mortality associated with this difficult problem.

The preventive effects of low-dose enteric-coated aspirin tablets on the development of colorectal tumours in Asian patients: a randomised trial

Objective To evaluate the influence of low-dose, enteric-coated aspirin tablets (100 mg/day for 2 years) on colorectal tumour recurrence in Asian patients with single/multiple colorectal tumours excised by endoscopy. Design A double-blinded, randomised, placebo-controlled multicentre clinical trial was conducted. Participants 311 subjects with single/multiple colorectal adenomas and adenocarcinomas excised by endoscopy were enrolled in the study (152 patients in the aspirin group and 159 patients in the placebo group). Enrolment began at the hospitals (n=19) in 2007 and was completed in 2009. Results The subjects treated with aspirin displayed reduced colorectal tumourigenesis and primary endpoints with an adjusted OR of 0.60 (95% CI 0.36 to 0.98) compared with the subjects in the placebo group. Subgroup analysis revealed that subjects who were non-smokers, defined as those who had smoked in the past or who had never smoked, had a marked reduction in the number of recurrent tumours in the aspirin-treated group. The adjusted OR for aspirin treatment in non-smokers was 0.37 (CI 0.21 to 0.68, p<0.05). Interestingly, the use of aspirin in smokers resulted in an increased risk, with an OR of 3.44. In addition, no severe adverse effects were observed in either group. Conclusions Low-dose, enteric-coated aspirin tablets reduced colorectal tumour recurrence in an Asian population. The results are consistent with those obtained from other randomised controlled trials in Western countries. The clinical trial registry website and the clinical trial number http://www.umin.ac.jp (number UMIN000000697).

Outcome of 141 cases of self-expandable metallic stent placements for malignant and benign colorectal strictures in a single center

BackgroundThe use of a self-expandable metallic stent (SEMS) has emerged as an alternative treatment option for malignant colorectal obstruction. Although the technical success rate of SEMS has been widely reported, outcome data are limited.MethodsThis retrospective study evaluated the short- and long-term outcomes of colorectal SEMS for malignant and benign disease in patients who underwent SEMS at a single center.ResultsOne surgeon inserted all stents under endoscopic and fluoroscopic guidance; 141 SEMS procedures were performed in 133 patients (82 males, mean age 69 years). The SEMS procedure was undertaken for: palliation of malignant obstruction in 30 patients (36 cases), and the technical success rate was 94%; a bridge to surgery for colorectal cancers in 98 patients/cases, and the technical success rate was 91%; benign stricture in 5 patients (7 cases), and the technical success rate was 100%. Due to anatomical differences, the success rate was lower at the cecum, descending colon, and sigmoid than in the rectosigmoid and rectum. In 11 cases of technical failures, the failures were due to technical problems in 9 cases (82%) and due to the state of the stricture in 2 cases (18%). Procedure-related complications occurred in 6 patients (4%): perforation in 3 and migration in 3. All perforation cases and one migration case underwent emergency surgery. There was no mortality. In the bridge to surgery group, postoperative complications were much lower in the clinical success cases (6%) than in the failure group (36%). In the palliation treatment group, long-term SEMS migration occurred in 4 patients (14%), and re-obstruction occurred in 5 patients (18%); the mean insertion period was 201 (range: 10–576) days.ConclusionsColorectal SEMS had feasible short and long-term results and low morbidity, making it a viable option for various types of colorectal obstruction with careful attention to the indications.

Self-expandable metallic stent placement as palliative treatment of obstructed colorectal carcinoma

BackgroundStent placement in palliation of unresectable colon cancer is an alternative to surgical treatment. The through-the-scope stent for the exclusive treatment of colorectal cancer is not available in Japan. This report describes the use of an esophageal stent and the technical modifications required for its success in the treatment of colorectal strictures. We describe various technical strategies for colorectal stent placement and report on the outcomes.MethodsMedical records of patients who underwent palliative colonic stenting between June 1997 and March 2003 were reviewed retrospectively, and the clinical outcome was evaluated.ResultsInsertion of a metallic esophageal stent was attempted in 12 patients (mean age, 73.0 years; 5 male, 7 female). Location of the stricture was in the rectum in 4 patients and in the sigmoid, descending, or transverse segments of the colon in 5, 1, and 2 patients, respectively. Two patients had recurrent colon cancer after surgery. The remaining 10 patients did not undergo surgery. Stent placement was technically successful in 11 patients, giving a technical success rate of 92%. Following successful stent placement, all but 1 patient obtained clinical success, generating a clinical success rate of 83%. Late complications occurred in 4 patients and included 2 migrations, 2 bleeds, and 1 obstruction. The complication rate of the procedure was 33.3%. There was no mortality or severe complications. The median survival period was 120 days.ConclusionsStent placement can be considered safe and effective palliation for unresectable colorectal cancer. With technical modification of an esophageal stent, this procedure is now feasible.

Mesorectal Excision With or Without Lateral Lymph Node Dissection for Clinical Stage II/III Lower Rectal Cancer (JCOG0212): A Multicenter, Randomized Controlled, Noninferiority Trial

Objective: The aim of the study was to confirm the noninferiority of mesorectal excision (ME) alone to ME with lateral lymph node dissection (LLND) in terms of efficacy. Background: Lateral pelvic lymph node metastasis is occasionally found in clinical stage II or III lower rectal cancer, and ME with LLND is the standard procedure in Japan. ME alone, however, is the international standard surgical procedure for rectal cancer. Methods: Eligibility criteria included histologically proven rectal cancer at clinical stage II/III; main lesion located in the rectum, with the lower margin below the peritoneal reflection; no lateral pelvic lymph node enlargement; Peformance Status of 0 or 1; and age 20 to 75 years. Patients were intraoperatively allocated to undergo ME with LLND or ME alone in a randomized manner. The primary endpoint was relapse-free survival, with a noninferiority margin for the hazard ratio of 1.34. Secondary endpoints included overall survival and local-recurrence-free survival. Analysis was by intention to treat. Results: In total, 701 patients were randomized to the ME with LLND (n = 351) and ME alone (n = 350) groups. The 5-year relapse-free survival in the ME with LLND and ME alone groups were 73.4% and 73.3%, respectively (hazard ratio: 1.07, 90.9% confidence interval 0.84–1.36), with a 1-sided P value for noninferiority of 0.0547. The 5-year overall survival, and 5-year local-recurrence-free survival in the ME with LLND and ME alone groups were 92.6% and 90.2%, and 87.7% and 82.4%, respectively. The numbers of patients with local recurrence were 26 (7.4%) and 44 (12.6%) in the ME with LLND and ME alone groups, respectively (P = 0.024). Conclusions: The noninferiority of ME alone to ME with LLND was not confirmed in the intent-to-treat analysis. ME with LLND had a lower local recurrence, especially in the lateral pelvis, compared to ME alone.

New methods of control against postoperative methicillin-resistant Staphylococcus aureus infection.

The incidence of postoperative infections caused by methicillin-resistantStaphylococcus aureus (MRSA) in Japan has been increasing dramatically. In March 1990, we assigned special doctors in infection control (infection control doctor, ICD), and defined comprehensive controls against MRSA infection. A total of 3 536 cases of digestive tract surgery performed at our department were studied during the period between September 1987 and August 1997. We changed the use of antibiotics to prevent postoperative infection. Cefazolin (CEZ) was employed for surgery of the upper digestive tract, including esophagus, stomach, duodenum, and gallbladder. Cefotiam (CTM) was employed for surgery of the lower digestive tract, liver, and pancreas. In esophageal resection, the tracheal tube was extracted during the early postoperative period, and for cervical esophagogastroanastomosis, the autosuture was changed to layer-to-layer anastomosis. We have achieved successful control of postoperative MRSA infection, the incidence having decreased to 0.3% (9/2703). In conclusion, our methods of control against postoperative MRSA infection implies that comprehensive measures of prevention, including the reviewed specification and usage of antibiotics and operation management, have been well implemented. This value is the lowest and the first of any domestic hospital or institute in Japan, suggesting a continued and significant decrease.

Survival outcomes following laparoscopic versus open D3 dissection for stage II or III colon cancer (JCOG0404): a phase 3, randomised controlled trial

BACKGROUND Although benefits of laparoscopic surgery compared with open surgery have been suggested, the long-term survival of patients undergoing laparoscopic surgery for colon cancer requiring Japanese D3 dissection remains unclear. We did a randomised controlled trial to establish non-inferiority of laparoscopic surgery to open surgery. METHODS We did an open-label, multi-institutional, randomised, two-arm phase 3 trial in 30 hospitals in Japan. Patients aged 20-75 years who had histologically proven colon cancer; tumours located in the caecum or ascending, sigmoid, or rectosigmoid colon; T3 or deeper lesions without involvement of other organs, node stages N0-2, and metastasis stage M0; and tumour size of 8 cm or smaller were included. Only accredited surgeons did surgery as an operator or instructor. Patients were randomly assigned (1:1) preoperatively to undergo D3 resection either by an open route or a laparoscopic route, via phone call or fax to the Japan Clinical Oncology Group (JCOG) Data Center. Randomisation used a minimisation method with a biased-coin assignment according to tumour location (caecum, ascending vs sigmoid, rectosigmoid) and institution. The primary endpoint was overall survival and was analysed by intention to treat. The non-inferiority margin for the hazard ratio (HR) was set at 1·366. This study is registered with UMIN Clinical Trials Registry, number C000000105, and ClinicalTrials.gov, number NCT00147134. FINDINGS Between Oct 1, 2004, and March 27, 2009, 1057 patients were randomly assigned to either open surgery (n=528) or laparoscopic surgery (n=529). 5-year overall survival was 90·4% (95% CI 87·5-92·6) for open surgery and 91·8% (89·1-93·8) for laparoscopic surgery. Laparoscopic D3 surgery was not non-inferior to open surgery for overall survival (HR 1·06, 90% CI 0·79-1·41; pnon-inferiority=0·073). 65 (13%) patients in the open surgery group and 53 (10%) patients in the laparoscopic surgery group had grade 2-4 adverse events. Grade 2-4 adverse events included diarrhoea (15 [3%] in the open surgery group vs 14 [3%] in the laparoscopic surgery group), paralytic ileus (six [1%] vs nine [2%]), and small intestine bowel obstruction (16 [3%] vs 11 [2%]). Two treatment-related deaths occurred in the open surgery group: one patient died 7 days after surgery (probably due to myocardial infarction), and one patient died from febrile neutropenia, pneumonia, diarrhoea, and gastrointestinal haemorrhage during postoperative chemotherapy. INTERPRETATION Laparoscopic D3 surgery was not non-inferior to open D3 surgery in terms of overall survival for patients with stage II or III colon cancer. However, because overall survival in both groups was similar and better than expected, laparoscopic D3 surgery could be an acceptable treatment option for patients with stage II or III colon cancer. FUNDING National Cancer Center Research and Development Fund, Grant-in-Aid for Cancer Research, and Health and Labour Sciences Research Grant for Clinical Cancer Research from the Ministry of Health, Labour and Welfare of Japan.

Omental cyst: report of a case.

Abstract We report the case of an omental cyst, a rare type of abdominal cystic lesion that is difficult to diagnose preoperatively. A 43-year-old man with no clinical symptoms was admitted to our hospital for investigation of an abdominal cyst detected by ultrasonography (US). We performed diagnostic examinations including US, computed tomography, and magnetic resonance imaging. An omental cyst was diagnosed because of its position and connection to the surrounding tissues. Pathological examination of the surgical specimen revealed endothelial cells on its internal wall and colonies of lymphocytes, confirming a diagnosis of lymphangioma, which is the most common type of omental cyst.

A Japanese prospective multicenter study of self-expandable metal stent placement for malignant colorectal obstruction: short-term safety and efficacy within 7 days of stent procedure in 513 cases.

BACKGROUND Endoscopic self-expandable metal stent placement has been used as an alternative to surgery for malignant colorectal obstruction; however, factors affecting its clinical outcome are unclear. OBJECTIVE To clarify the short-term safety and efficacy of endoscopic self-expandable metal stent placement for malignant colorectal obstruction and to identify factors associated with its clinical and technical failure. DESIGN Prospective clinical cohort study. SETTING Fourteen academic centers and 32 community hospitals. PATIENTS A total of 513 consecutive patients with malignant colorectal obstruction. INTERVENTION Endoscopic self-expandable metal stent placement, sharing of stent placement methods among participating facilities. MAIN OUTCOME MEASUREMENTS The primary endpoint was clinical success, defined as symptom and radiological finding resolution within 24 hours. Secondary endpoints were technical success and adverse events. The follow-up period was 7 days. RESULTS The clinical and technical success rates were 95.5% and 97.9%, respectively. Major adverse events included perforation (2.1%), stent migration (1.0%), and stent occlusion (0.8%). The main causes of perforation were the procedure itself (0.8%) and comorbidities (obstructive colitis and impending perforation) not apparent before stent placement (0.6%). Extrinsic tumor origin was independently associated with the clinical failure after stent placement (odds ratio 4.23; 95% confidence interval, 1.21-14.79; P = .02). Stricture marking trended toward a negative association with technical failure (P = .09). LIMITATIONS Noncomparative study. CONCLUSION Strict inclusion criteria and stricture marking may improve the technical and clinical success of stent placement.