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ABSTRACT: BACKGROUND: Although, in Western countries, oxaliplatin-based regimens have been established as a gold standard treatment for patients with stage III or high risk stage II colon cancer after curative resection, in Japan fluorouracil-based regimens have been widely accepted and recommended in the guidelines for adjuvant settings in patients with stage III colon cancer. S-1, an oral preparation evolved from uracil and tegafur, has equivalent efficacy to uracil and tegafur/leucovorin for treating patients with advanced colorectal cancer and might be a suitable regimen in an adjuvant setting. However, the completion rate of the standard six-week cycle of the S-1 regimen is poor and the establishment of an optimal treatment schedule is critical. Therefore, we will conduct a multicenter randomized phase II trial to compare six-week and three-week cycles to establish the optimal schedule of S-1 adjuvant therapy for patients with stage III colon cancer after curative resection. METHODS: The study is an open-label, multicenter randomized phase II trial. The primary endpoint of this study is three-year disease-free survival rate. Secondary endpoints are the completion rate of the treatment, relative dose intensity, overall survival, disease-free survival, and incidence of adverse events. The sample size was 200, determined with a significance level of 0.20, power of 0.80, and non-inferiority margin of a 10% absolute difference in the primary endpoint. DISCUSSION: Although S-1 has not been approved yet as a standard treatment of colon cancer in an adjuvant setting, it is a promising option. Moreover, in Japan S-1 is a standard treatment for patients with stage II/III gastric cancer after curative resection and a promising option for patients with colorectal liver metastases in an adjuvant setting. However, a six-week cycle of treatment is not considered to be the best schedule, and some clinicians use a modified schedule, such as a three-week cycle to keep a sufficient dose intensity with few adverse events. Therefore, it will be useful to determine whether a three-week cycle has an equal or greater efficacy and tolerance to side-effects compared with the standard six-week cycle schedule, and thus may be the most suitable treatment schedule for S-1 treatment.Trial registration: The University Hospital Medical Information Network (UMIN) Clinical Trials Registry UMIN000006750.
Trials 01/2013; 14(1):17. · 2.02 Impact Factor
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Gen Sugawara,
Tomoki Ebata,
Yukihiro Yokoyama,
Tsuyoshi Igami,
Toshio Kokuryo,
Nobuyuki Tsunoda,
Masahide Fukaya,
Keisuke Uehara,
Keita Itatsu, Yuichiro Yoshioka,
Masato Nagino
Gan to kagaku ryoho. Cancer & chemotherapy 10/2012; 39(10):1483-5.
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ABSTRACT: The clinical introduction of double-balloon endoscopy (DBE) has brought about a revolution in the diagnosis and the treatment of diseases of the small intestine. DBE allows not only direct observation of the entire small intestine, but also interventional therapies, tissue sampling and India ink marking (tattooing). Single incision laparoscopic surgery (SILS) was developed from conventional laparoscopic surgery to further reduce the degree of invasiveness. SILS requires only one umbilical incision, thus resulting in almost scarless surgery. This report presents three cases of small intestinal bleeding successfully treated by SILS following tattooing under DBE. The average operative time was 67 min and average blood loss was 5 ml. All patients immediately recovered without any complications. SILS, in conjunction with presurgical tattooing by DBE for small intestinal bleeding is considered to be an ideal approach in terms of minimal surgical trauma and aesthetics.
Surgery Today 08/2012; · 1.22 Impact Factor
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ABSTRACT: We report a case of unresectable multiple liver metastases, in which there was such a good response to panitumumab as third-line chemotherapy, that they were converted into resectable metastases. A 67-year-old man was admitted to our department for rectal cancer with synchronous unresectable multiple liver metastases. After the primary lesion was resected, modified FOLFOX6 regimen was started as first-line chemotherapy. After 10 courses of FOLFOX6 followed by 14 courses of sLV5FU2 regimen, the liver metastases became smaller and were thought to be resectable. Before hepatectomy, we performed portal vein embolization to enlarge the remnant liver, but the tumor grew larger again and we had to cancel the operation. Then, the second-line chemotherapy with FOLFIRI regimen failed. As third-line chemotherapy, panitumumab alone was administered to him and the tumor greatly shrank after 5 courses. We were able to resect the liver metastases with extended right posterior segmentectomy and partial resection. He has been well without recurrence for one year since hepatectomy. This case is rare in that panitumumab alone as third-line chemotherapy shrank unresectable liver metastases and made them resectable. The result is highly suggestive for management, including chemotherapy and operation of multiple liver metastases from colorectal cancer.
Gan to kagaku ryoho. Cancer & chemotherapy 07/2012; 39(7):1143-5.
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Yukihiro Yokoyama,
Tomoki Ebata,
Tsuyoshi Igami,
Gen Sugawara,
Yuh Takahashi,
Toshio Kokuryo,
Nobuyuki Tsunoda,
Masahide Fukaya,
Keisuke Uehara,
Keita Itatsu, Yuichiro Yoshioka,
Masato Nagino
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ABSTRACT: The survival benefit of extended surgery for advanced pancreatic cancer has been denied by four randomized controlled trials. However, there still is confusion and conflict over the definition and effective treatment strategy for so-called locally advanced or borderline resectable pancreatic cancer. Although there are a number of reports that showed outcomes of preoperative chemotherapy or chemoradiotherapy for this disease, the definitions and treatment regimens described in these studies vary. Moreover, all of the studies were Phase I / II trials or retrospective analysis, and there is no Phase III trial currently focused on this issue. It is urgently necessary to establish an international consensus on the definition of borderline resectable pancreatic cancer. The usefulness of neoadjuvant treatment for this disease should also be elucidated in future clinical trials. In this review article, we discuss the current understanding and definition of borderline resectable pancreatic cancer, and the value of neoadjuvant treatment strategy for treating it.
Gan to kagaku ryoho. Cancer & chemotherapy 03/2012; 39(3):337-41.
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Keisuke Uehara, Yuichiro Yoshioka,
Yoshiro Taguchi,
Tsuyoshi Igami,
Tomoki Ebata,
Yukihiro Yokoyama,
Gen Sugawara,
Satoshi Tsukushi,
Yoshihiro Nishida,
Yasushi Yoshino,
Masato Nagino
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ABSTRACT: A combined ischiopubic rami resection is extremely rare in the field of gastroenterologic surgery. We report a case of a locally recurrent rectal cancer that was successfully treated by total pelvic exenteration with combined ischiopubic rami resection. A 58-year-old male with locally recurrent rectal cancer and liver metastases was referred to our hospital. Computed tomography and magnetic resonance imaging showed a perineal tumor, which had invaded the prostate, urethra, and obturator internus muscle, and two liver metastases. Because the perineal tumor was very close to the dorsal vein complex and the pubic symphysis, it was considered difficult to approach and divide the dorsal vein complex, and still retain oncologic safety. To achieve R0 resection, total pelvic exenteration with ischiopubic rami resection, total emasculation and partial liver resection were performed. Pathological examination revealed that surgical margins were negative for cancer cells. Although reconstruction of the pelvic ring was not performed, his ambulatory function had recovered to an almost normal status at 6 months after the operation.
Japanese Journal of Clinical Oncology 11/2011; 42(1):58-62. · 1.78 Impact Factor
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Keisuke Uehara,
Seiji Ishiguro,
Kazuhiro Hiramatsu,
Hideki Nishio,
Eiji Takeuchi,
Daisuke Takahari, Yuichiro Yoshioka,
Yu Takahashi,
Tomoki Ebata,
Kenichi Yoshimura,
Kei Muro,
Masato Nagino
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ABSTRACT: Recently, in patients with unresectable colorectal liver metastasis, liver resection sometimes becomes possible by intensive systemic chemotherapy, i.e. conversion therapy. However, among cases that do not respond well to first-line chemotherapy, it is rare that second-line chemotherapy results in a marked response allowing liver resection. We consider that the liver resection rate may be increased by initiating second-line treatment at an earlier stage before progression subsequent to first-line chemotherapy. We are conducting a multicentre Phase II study to evaluate the efficacy and safety of sequential chemotherapy using six cycles of cetuximab plus FOLFIRI (5-fluorouracil, folinic acid and irinotecan) followed by six cycles of bevacizumab plus FOLFOX (5-fluorouracil, folinic acid and oxaliplatin) as conversion chemotherapy. The primary endpoint is the liver resection rate during the bevacizumab + FOLFOX phase. Fifty patients are required for this study.
Japanese Journal of Clinical Oncology 08/2011; 41(10):1229-32. · 1.78 Impact Factor
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ABSTRACT: A supraportal right posterior hepatic artery (RPHA), which runs cranially to the right portal vein and goes to the liver, has never been described.
The course of the RPHA to the right portal vein was evaluated, using (1) computed tomography (CT) arteriography and portography in 300 patients who underwent multidetector row CT (radiologic study) and (2) operative records in 203 patients who underwent left-sided hepatectomy for perihilar cholangiocarcinoma (surgical study).
In the radiologic study, an infraportal type RPHA was observed in 239 (79.7%) patients, a supraportal type in 35 (11.7%), and a combined type in 26 (8.7%). In the surgical study, an infraportal type was observed in 179 (88.2%) patients, a supraportal type in 11 (5.4%), and a combined type in 13 (6.4%). In two patients with the combined type RPHA, the supraportal hepatic artery of the right posterior superior segment (A7) was injured during surgery. In another two patients with advanced carcinoma involving the supraportal PRHA, combined hepatic artery resection and reconstruction was necessary. Overall, in 4 (17.4%) of the 24 hepatectomized patients with supraportal or combined type RPHA, iatrogenic injury during surgery or cancer invasion of the hepatic artery occurred due to the course of the RPHA itself. In contrast, 179 hepatectomized patients with infraportal type RPHA did not have such course-dependent complications.
The supraportal RPHA runs just beneath the right hepatic duct, which may function as an anatomic trap during hepatobiliary and transplant surgery.
World Journal of Surgery 03/2011; 35(6):1340-4. · 2.36 Impact Factor
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ABSTRACT: A new approach to closing a malignant enterocutaneous fistula is reported. Transverse colon cancer recurred around the superior mesenteric vein along with a duodenocutaneous fistula, thus causing severe dermatitis. The tumor was partially resected at the fascia level and the fistula measured 2.5 cm in diameter. A left rectus abdominis musculocutaneous flap failed to close the fistula because of graft necrosis. A jejunal flap measuring 8 cm in length was prepared by sacrificing about 15 cm of adjacent jejunum to create the pedicle. The mucosal layer of the flap was removed and the fistula was closed, then the tumor surface was covered. Two weeks later, the skin defect was covered with free skin grafting. The patient died of cancer 6 months after surgery, but there was no recurrence of the fistula.
Surgery Today 02/2006; 36(10):941-3. · 1.22 Impact Factor
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ABSTRACT: Although right-sided colon cancer occasionally invades the second part of the duodenum, there is no standard procedure for reconstructing a large duodenal defect after resection. This report describes a new approach we recently devised. After resecting the right hemicolon and the involved duodenum, a segment of terminal ileum was isolated on the vascular pedicle, sacrificing the adjacent ileum. We created a flap by opening the segment along the antimesenteric border, and used this flap to cover the defect. This method does not create a nonanatomical bypass and fewer intestinal anastomoses are required than for Roux-en-Y reconstruction.
Surgery Today 02/2004; 34(4):386-8. · 1.22 Impact Factor
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ABSTRACT: The continuous vertical mattress technique for anastomoses in the gastrointestinal or colorectal surgery has not been well reported in literature.
We used the technique for all hand-sewn anastomoses with double-armed monofilament absorbable suture (Glycomer 631).
In the 266 consecutive anastomoses in 242 cases, there were 4 anastomotic leakages (1.5%) and 1 anastomotic stenosis (0.4%).
The technique was feasible, time-saving, economical and with satisfactory results.
The American Journal of Surgery 12/2002; 184(5):446-8. · 2.78 Impact Factor
