A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach

Adenocarcinoma of Hepatic Flexure (Diagnosis) Clinical Trial

— LRHCTC-1  

Official title:

A Prospective Randomized Controlled Clinical Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02949440
• Other study ID #: LRHCTC-1
• Status: Recruiting
• Phase: N/A
• First received: October 25, 2016
• Last updated: October 28, 2016
• Start date: October 2016
• Est. completion date: December 2024

Study information

• Verified date: October 2016
• Source: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Contact: Liao-nan Zou, MD.
• Phone: 0086-020-13423663496
• Email: 13423663496[@]163.com
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

To investigate the clinical application value of laparoscopic radical right hemicolectomy using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective randomized controlled clinical study.

Description:

To compare the caudal-to-cranial approach with the medial-to-lateral approach in laparoscopic right hemicolectomy for the advance right colon cancer.

A prospective randomized controlled trial will be performed in the GI department,the Guangdong provincial hospital of Chinese Medicine from October 2016 to October 2024.The sample size，150 cases with advanced right colon cancer, will be needed after calculated by the statistics .The 150 cases will be randomly divided into two groups: laparoscopic radical right hemicolectomy using the caudal-to-cranial(CtC) approach(GroupCtC) and laparoscopic radical right hemicolectomy using the medial-to-lateral(MtL) approach (GroupMtL). Primary outcomes are the operative time，The secondary outcomes are the total blood loss,the number of lymph nodes dissected,the average time of ground activities,the time to first flatus,the hospital stay,the intra-operative complication and the post-operative complication，and others' outcomes are the Disease-free survival rate(DFS) at 3 years and 5 years,the Overall survival rate（OS）at 3 years and 5 years.The data in two groups will be compared.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

1. The age limits is 18-80 years old;

2. The clinical staging was II,III carcinoma of right colon,located in right-sided colon;

3. The preoperative imaging confirmed that the tumor did not involve adjacent organs;

4. American Society of anesthesiologists (ASA) score less than or equal to Level III;

5. Criteria of performance status karnofsky is greater than or equal to 60.

Exclusion Criteria:

1. The patients' age limits is Less than 18 years old, or more than 80 years old

2. The preoperative imaging confirmed that the tumor involve adjacent organs;

3. The tumor have been finding distant metastases;

4. American Society of anesthesiologists (ASA) score more than 3;

5. Criteria of performance status karnofsky is lower than 60;

6. It is the carcinoma of right colon with multiple colonic polyps Disease;

7. there is a laparoscopic surgery contraindications.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Adenocarcinoma of Hepatic Flexure (Diagnosis)
• Ascending Colon Cancer
• Cancer Flexure Hepatic
• Colonic Neoplasms
• Ileocaecal Valve Carcinoma

Intervention

Procedure:
• the caudal-to-cranial approach
Cutting the peritoneum along the line between the right mesocolon and retroperitoneum, enter the Toldt's space to dissect the posterior of Superior mesenteric vein and Superior mesenteric artery and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein. In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called the caudal-to-cranial approach.
• the medial-to-lateral approach
First, the pedicle of ileocolic vessels is identified and the mesocolon is dissected between the pedicle and the periphery of the Superior mesenteric vein to expose the second portion of the duodenum. The ileocolic vessels are then cut at their roots. The ascending mesocolon is separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon.This approach is the medial-to-lateral(MtL) approach

Locations

Country	Name	City	State
China	GI surgery,Guangdong Province Hospital of Chinese Medicine	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

Li H, He Y, Lin Z, Xiong W, Diao D, Wang W, Wan J, Zou L. Laparoscopic caudal-to-cranial approach for radical lymph node dissection in right hemicolectomy. Langenbecks Arch Surg. 2016 Aug;401(5):741-6. doi: 10.1007/s00423-016-1465-5. — View Citation

Zou L, Xiong W, Li H, He Y, Diao D, Zheng Y, Luo L, Tan P, Wang W, Wan J. [Efficacy analysis of laparoscopic radical right hemicolectomy using caudal-to-cranial approach]. Zhonghua Wei Chang Wai Ke Za Zhi. 2015 Nov;18(11):1124-7. Chinese. — View Citation

Zou L, Xiong W, Mo D, He Y, Li H, Tan P, Wang W, Wan J. Laparoscopic Radical Extended Right Hemicolectomy Using a Caudal-to-Cranial Approach. Ann Surg Oncol. 2016 Aug;23(8):2562-3. doi: 10.1245/s10434-016-5215-2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	the 3-year and 5-year Disease-free survival(DFS)		up to 3 years and 5 years	No
Other	3-year and 5-year Overall survival(OS)		up to 3 years and 5 years	No
Primary	the operation time		up to 36 months	Yes
Secondary	the total blood loss		up to 36 months	Yes
Secondary	the number of lymph nodes dissected		up to 36 months	Yes
Secondary	the average time of ground activities		up to 36 months	Yes
Secondary	the time to first flatus		up to 36 months	Yes
Secondary	the intra-operative complication and the post-operative complication		up to 36 months	Yes