A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach (LRHCTC-1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ascending Colon Cancer; Ileocaecal Valve Carcinoma; Cancer Flexure Hepatic; Adenocarcinoma of Hepatic Flexure (Diagnosis)
• Intervention / Treatment: Procedure: the caudal-to-cranial approach; Procedure: the medial-to-lateral approach

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liao-nan Zou, MD.; Phone Number: 0086-020-13423663496; Email: 13423663496@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Recruiting
      • GI surgery,Guangdong Province Hospital of Chinese Medicine
      • Contact: liao-nan Zou, MD; Phone Number: 0086-020-13423663496; Email: 13423663496@163.com
      • Contact: xin-quan Lu, MD; Phone Number: 0086-020-18898607919; Email: 18898607919@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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（SMV）and Superior mesenteric artery（SMA）and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein（SMV）. In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called caudal-to-cranial approach.	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.
ACTIVE_COMPARATOR: 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（SMV）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	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the operation time	up to 36 months

Secondary Outcome Measures

Outcome Measure	Time Frame
the total blood loss	up to 36 months
the number of lymph nodes dissected	up to 36 months
the average time of ground activities	up to 36 months
the time to first flatus	up to 36 months
the intra-operative complication and the post-operative complication	up to 36 months

Other Outcome Measures

Outcome Measure	Time Frame
the 3-year and 5-year Disease-free survival（DFS）	up to 3 years and 5 years
3-year and 5-year Overall survival（OS）	up to 3 years and 5 years

Collaborators and Investigators

• Sponsor: Guangdong Provincial Hospital of Traditional Chinese Medicine
• Investigators: Principal Investigator: Liao-nan Zou, professor, GI surgery,Guangdong Province Hospital of Chinese Medicine; Study Director: Jin Wan, PhD, GI surgery,Guangdong Province Hospital of Chinese Medicine

Publications and helpful links

General Publications

• 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.
• 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. Epub 2016 Apr 12.
• 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. Epub 2016 Jun 18.

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ANTICIPATED): February 1, 2020
• Study Completion (ANTICIPATED): December 1, 2024

Study Registration Dates

• First Submitted: October 25, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (ESTIMATE): October 31, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 28, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Laparoscopic right Hemicolectomy; Caudal-to-cranial Approach
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Adenocarcinoma
• Other Study ID Numbers: LRHCTC-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES