Clinical trial NCT00635466: Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
Official title: Phase II Trial to Evaluate Laparoscopic Surgery for Stage 0/I Rectal Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Rectal Cancer
Keywords: laparoscopic surgery, rectal carcinoma, phase II trial
Lead sponsor: Japan Society of Laparoscopic Colorectal Surgery
Sponsor class: NETWORK
First posted: 2008-03-13
Enrollment: 495
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: overall survival
timeFrame: 5 year
Secondary outcomes:
measure: anastomotic leakage rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Sagamihara
country: Japan
facility: Kitasato University Hospital
state: Kanagawa
Study officials:
affiliation: Kitasato University Hospital
name: Masahiko Watanabe, PhD
role: STUDY_CHAIR
References:
citation: 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. doi: 10.1093/jjco/hyn054. Epub 2008 Jun 26.
citation: Ito M, Yamamoto S, Okuda J, Fujii S, Yamaguchi S, Otsuka K, Yoshimura K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Long-term survival outcomes following laparoscopic surgery for clinical stage 0/I rectal carcinoma. Ann Gastroenterol Surg. 2020 May 20;4(3):294-300. doi: 10.1002/ags3.12333. eCollection 2020 May.
citation: Yamamoto S, Ito M, Okuda J, Fujii S, Yamaguchi S, Yoshimura K, Sugihara K, Watanabe M; Japan Society of Laparoscopic Colorectal Surgery. Laparoscopic surgery for stage 0/I rectal carcinoma: short-term outcomes of a single-arm phase II trial. Ann Surg. 2013 Aug;258(2):283-8. doi: 10.1097/SLA.0b013e318283669c.