Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma - Full Text View

Sponsored by:	Japan Society of Laparoscopic Colorectal Surgery
Information provided by:	Japan Society of Laparoscopic Colorectal Surgery
ClinicalTrials.gov Identifier:	NCT00635466

Purpose

The purpose of this study is to examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma

Condition	Intervention	Phase
Rectal Cancer	Procedure: laparoscopic surgery for rectal carcinoma	Phase II

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Surgery

U.S. FDA Resources

Further study details as provided by Japan Society of Laparoscopic Colorectal Surgery:

Primary Outcome Measures:

overall survival [ Time Frame: 5 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

anastomotic leakage rate [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	350
Study Start Date:	February 2008
Estimated Study Completion Date:	January 2016
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Lap, 1: Experimental Patients undergoing laparoscopic surgery for rectal carcinoma	Procedure: laparoscopic surgery for rectal carcinoma Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (<8 cm).

Arms

Assigned Interventions

Lap, 1: Experimental

Patients undergoing laparoscopic surgery for rectal carcinoma

Procedure: laparoscopic surgery for rectal carcinoma

Laparoscopic resection of the rectum with adequate lymphadenectomy is performed according to the General Rules for Clinical and Pathological Studies on Cancer of the Colon, Rectum and Anus edited by the Japanese Society for Cancer of the Colon and Rectum. The extent of lymphadenectomy and site of ligation and division of the inferior mesenteric vessels were decided by the surgeon in charge. Pneumoperitoneal approaches are used to explore the abdomen, mobilize the left side colon, identify critical structures and ligate the vascular pedicle. Mobilization of the rectum, excision of the mesorectum, rectal transection, removal of the specimen, and reconstruction are performed by the pneumoperitoneal approach or the extracorporeal approach via a small incision (<8 cm).

Detailed Description:

Recently reported randomized controlled trials demonstrated that laparoscopic surgery was comparable or superior to open surgery regarding the long-term outcome for colon and rectosigmoidal carcinoma; however, controversy persists regarding the appropriateness of laparoscopic surgery for patients with rectal carcinoma because of the uncertainty of the long-term outcome, and of concerns over the safety of the procedure. In Japan, lateral lymph node dissection combined with total mesorectal excision remains the standard surgical procedure for patients with advanced lower rectal carcinoma, and lateral lymph node dissection by laparoscopy is still an unexplored frontier. To examine the technical and oncological feasibility of laparoscopic surgery for rectal carcinoma, a phase II trial will be conducted in patients with a preoperative diagnosis of stage 0/I rectal carcinoma, under the direction of the Japan Society of Laparoscopic Colorectal Surgery, to which leading hospitals in laparoscopic surgery for colorectal carcinoma in Japan are members.

Eligibility

Ages Eligible for Study:	20 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Histologically proven rectal carcinoma.
Tumor located in the rectum.
Clinical Tis, T1, T2 N0 M0
Without multiple lesions other than carcinoma in situ
Tumor size <8 cm.
Sufficient organ function.
No bowel obstruction.
No history of major colorectal surgery.
No history of chemotherapy or radiotherapy.
Provide written informed consent.

Exclusion Criteria:

Synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ.
Pregnant or lactating women.
Severe mental disease.
Severe pulmonary emphysema, interstitial pneumonitis or ischemic heart disease.
Continuous systemic steroid therapy.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00635466

Contacts

Contact: Seiichiro Yamamoto, PhD	+81-3-3542-2511 ext 7013	seyamamo@ncc.go.jp
Contact: Masahiko Watanabe, PhD	+81-42-778-8735	gekaw@med.kitasato-u.ac.jp

Locations

Japan, Kanagawa
Kitasato University Hospital	Recruiting
Sagamihara, Kanagawa, Japan, 228-8555
Contact: Masahiko Watanabe, PhD +81-42-778-8735 gekaw@med.kitasato-u.ac.jp
Contact: Seiichiro Yamamoto, PhD +81-3-3542-2511 ext 7013 seyamamo@ncc.go.jp
Principal Investigator: Masahiko Watanabe, PhD

Sponsors and Collaborators

Japan Society of Laparoscopic Colorectal Surgery

Investigators

Study Chair:

Masahiko Watanabe, PhD

Kitasato University Hospital

More Information

Additional Information:

Click here for the information regarding the Japanese Society for Cancer of the Colon and Rectum (JSCCR). This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Yamamoto S, Yoshimura K, Konishi F, Watanabe M. Phase II trial to evaluate laparoscopic surgery for Stage 0/I rectal carcinoma. Jpn J Clin Oncol. 2008 Jul;38(7):497-500. Epub 2008 Jun 26.

Responsible Party:	Kitasato University Hospital ( Masahiko Watanabe )
Study ID Numbers:	Lap RC, NCCHCT19-49
Study First Received:	March 6, 2008
Last Updated:	July 23, 2009
ClinicalTrials.gov Identifier:	NCT00635466 History of Changes
Health Authority:	Japan: Japan Clinical Oncology Group

Keywords provided by Japan Society of Laparoscopic Colorectal Surgery:

laparoscopic surgery, rectal carcinoma, phase II trial

Study placed in the following topic categories:

Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Rectal Neoplasm
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Carcinoma
Digestive System Diseases
Rectal Cancer
Gastrointestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neoplasms by Histologic Type
Digestive System Neoplasms
Rectal Neoplasms
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Carcinoma
Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 10, 2009