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

Primary Purpose

Ascending Colon Cancer, Ileocaecal Valve Carcinoma, Cancer Flexure Hepatic

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
the caudal-to-cranial approach
the medial-to-lateral approach
Sponsored by
Guangdong Provincial Hospital of Traditional Chinese Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ascending Colon Cancer focused on measuring Laparoscopic right Hemicolectomy, Caudal-to-cranial Approach

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • GI surgery,Guangdong Province Hospital of Chinese MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the caudal-to-cranial approach

the medial-to-lateral approach

Arm Description

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.

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

Outcomes

Primary Outcome Measures

the operation time

Secondary Outcome Measures

the total blood loss
the number of lymph nodes dissected
the average time of ground activities
the time to first flatus
the intra-operative complication and the post-operative complication

Full Information

First Posted
October 25, 2016
Last Updated
October 28, 2016
Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT02949440
Brief Title
A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach
Acronym
LRHCTC-1
Official Title
A Prospective Randomized Controlled Clinical Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Recruiting
Study Start Date
October 2016 (undefined)
Primary Completion Date
February 2020 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Provincial Hospital of Traditional Chinese Medicine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascending Colon Cancer, Ileocaecal Valve Carcinoma, Cancer Flexure Hepatic, Adenocarcinoma of Hepatic Flexure (Diagnosis)
Keywords
Laparoscopic right Hemicolectomy, Caudal-to-cranial Approach

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
the caudal-to-cranial approach
Arm Type
Experimental
Arm Description
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.
Arm Title
the medial-to-lateral approach
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
the caudal-to-cranial approach
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
the medial-to-lateral approach
Intervention Description
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
Primary Outcome Measure Information:
Title
the operation time
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
the total blood loss
Time Frame
up to 36 months
Title
the number of lymph nodes dissected
Time Frame
up to 36 months
Title
the average time of ground activities
Time Frame
up to 36 months
Title
the time to first flatus
Time Frame
up to 36 months
Title
the intra-operative complication and the post-operative complication
Time Frame
up to 36 months
Other Pre-specified Outcome Measures:
Title
the 3-year and 5-year Disease-free survival(DFS)
Time Frame
up to 3 years and 5 years
Title
3-year and 5-year Overall survival(OS)
Time Frame
up to 3 years and 5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The age limits is 18-80 years old; The clinical staging was II,III carcinoma of right colon,located in right-sided colon; The preoperative imaging confirmed that the tumor did not involve adjacent organs; American Society of anesthesiologists (ASA) score less than or equal to Level III; Criteria of performance status karnofsky is greater than or equal to 60. Exclusion Criteria: The patients' age limits is Less than 18 years old, or more than 80 years old The preoperative imaging confirmed that the tumor involve adjacent organs; The tumor have been finding distant metastases; American Society of anesthesiologists (ASA) score more than 3; Criteria of performance status karnofsky is lower than 60; It is the carcinoma of right colon with multiple colonic polyps Disease; there is a laparoscopic surgery contraindications.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liao-nan Zou, MD.
Phone
0086-020-13423663496
Email
13423663496@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liao-nan Zou, professor
Organizational Affiliation
GI surgery,Guangdong Province Hospital of Chinese Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jin Wan, PhD
Organizational Affiliation
GI surgery,Guangdong Province Hospital of Chinese Medicine
Official's Role
Study Director
Facility Information:
Facility Name
GI surgery,Guangdong Province Hospital of Chinese Medicine
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
liao-nan Zou, MD
Phone
0086-020-13423663496
Email
13423663496@163.com
First Name & Middle Initial & Last Name & Degree
xin-quan Lu, MD
Phone
0086-020-18898607919
Email
18898607919@163.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
26616807
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.
Results Reference
result
PubMed Identifier
27072997
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. Epub 2016 Apr 12.
Results Reference
result
PubMed Identifier
27318491
Citation
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.
Results Reference
result

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

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