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Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach Orientated by SMA or SMV

Primary Purpose

Right Colic Lymphadenopathy

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SMA-orientated right hemicoloectomy
SMV-orientated right hemicoloectomy
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Right Colic Lymphadenopathy focused on measuring right colon cancer, superior mesenteric artery, superior mesenteric vein

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suitable for curative surgery between 18 - 85 years old;
  • American Society of Anesthesiologists(ASA) grade I-III;
  • Preoperative pathological diagnosis of adenocarcinoma;
  • Tumor located at the right colon;
  • Informed consent;
  • No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.

Exclusion Criteria:

  • Pregnant patient;
  • History of psychiatric disease;
  • Use of systemic steroids;
  • Simultaneous multiple primary colorectal cancer;
  • Preoperative enhanced CT scan of chest, abdominal and pelvic cavity shows:

    1. Tumor involves the surrounding organs and combined organ resection needed to be done;
    2. distant metastasis;
    3. unable to perform R0 resection;
  • History of any other malignant tumor in recent 5 years;
  • Patients need emergency operation: mechanic ileus, perforation.
  • Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
  • Conversion from laparoscopic surgery to laparotomy;

Sites / Locations

  • Jiangsu province hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SMA-orientated right hemicoloectomy

SMV-orientated right hemicoloectomy

Arm Description

SMA-orientated right hemicoloectomy

SMV-orientated right hemicoloectomy

Outcomes

Primary Outcome Measures

number of lymph nodes retrieved

Secondary Outcome Measures

disease-free survival
overall survival
recurrence-free survival
early complication rate
Early complication is defined as a complication that occurred between the finish of the surgery and postoperative day. Complications includes anastomotic leakage, anastomotic bleeding, chyle leakage, wound infection, pulmonary embolism, myocardial infarction et al.The Clavien-Dindo Classification of Surgical Complications will be applied to access the degree of severity of postoperative complications.
operative time

Full Information

First Posted
October 30, 2017
Last Updated
October 30, 2017
Sponsor
The First Affiliated Hospital with Nanjing Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT03329495
Brief Title
Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach Orientated by SMA or SMV
Official Title
A Randomized Controlled Clinical Trial to Investigate the Effect of SMA- or SMV- Orientated Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 2018 (Anticipated)
Primary Completion Date
January 2018 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Affiliated Hospital with Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
A randomized controlled clinical trial to compare the outcomes of SMA- and SMV- orientated laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach
Detailed Description
In 2008, Germany scholar W. Hohenberger proposed the idea of complete mesocolic excision (CME) and central vascular ligation (CVL) for the standardization of colonic cancer surgery. This concept has been widely recognized and accepted. This radical operation attempts to remove the mesocolon intactly by careful dissection along the embryologic tissue planes and transection of the supplying vessels at their origin. For right-sided colon cancer, this approach involves division of the vessels at their origin from the superior mesenteric artery (SMA) and superior mesenteric vein (SMV). In our opinion, full exposure of the SMA and SMV is necessary to make sure that the origin of the colonic arteries being truly exposed and tied centrally at their origin and a maximal harvest of the regional lymphnodes. For locally advanced colon cancer, SMA- orientated surgery may be more meaningful to recerve a radical lymphadenectomy and bring benefit for their survival. However, in the traditional practise, the lymph node dissection is orientated by SMV and SMA is not exposed, tissue around SMA is left behind. In this study, eligible patients with right colon cancer will be randomly allocated to receive either SMA- or SMV- orientated laparoscopic right hemicoloectomy. 100 patients will be enrolled in each group. In SMV- orientated surgery group, SMA is not exposed and the left boundary of resection is the left side of SMV. In SMA- orientated surgery group, the left boundary of resection is the left side of SMA and SMA is exposed.Artery sheath is not necessarily to be opened. Postoperative pathology will be analyzed with the number of lymph nodes retrieved. Postoperative recovery process and long term survival will be followed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Right Colic Lymphadenopathy
Keywords
right colon cancer, superior mesenteric artery, superior mesenteric vein

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SMA-orientated right hemicoloectomy
Arm Type
Active Comparator
Arm Description
SMA-orientated right hemicoloectomy
Arm Title
SMV-orientated right hemicoloectomy
Arm Type
Experimental
Arm Description
SMV-orientated right hemicoloectomy
Intervention Type
Procedure
Intervention Name(s)
SMA-orientated right hemicoloectomy
Intervention Description
Laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMA. The left boundary of resection is the left side of SMA, and artery sheath is not necessarily being opened.
Intervention Type
Procedure
Intervention Name(s)
SMV-orientated right hemicoloectomy
Intervention Description
Laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMV. The left boundary of resection is the left side of SMV, and SMA is not exposed.
Primary Outcome Measure Information:
Title
number of lymph nodes retrieved
Time Frame
1 day
Secondary Outcome Measure Information:
Title
disease-free survival
Time Frame
3 years
Title
overall survival
Time Frame
3 years
Title
recurrence-free survival
Time Frame
3 years
Title
early complication rate
Description
Early complication is defined as a complication that occurred between the finish of the surgery and postoperative day. Complications includes anastomotic leakage, anastomotic bleeding, chyle leakage, wound infection, pulmonary embolism, myocardial infarction et al.The Clavien-Dindo Classification of Surgical Complications will be applied to access the degree of severity of postoperative complications.
Time Frame
30 days
Title
operative time
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suitable for curative surgery between 18 - 85 years old; American Society of Anesthesiologists(ASA) grade I-III; Preoperative pathological diagnosis of adenocarcinoma; Tumor located at the right colon; Informed consent; No history of familial adenomatous polyposis, ulcerative colitis or Crohn's disease. Exclusion Criteria: Pregnant patient; History of psychiatric disease; Use of systemic steroids; Simultaneous multiple primary colorectal cancer; Preoperative enhanced CT scan of chest, abdominal and pelvic cavity shows: Tumor involves the surrounding organs and combined organ resection needed to be done; distant metastasis; unable to perform R0 resection; History of any other malignant tumor in recent 5 years; Patients need emergency operation: mechanic ileus, perforation. Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc). Conversion from laparoscopic surgery to laparotomy;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yueming Sun, PhD
Phone
02568136026
Email
jssym@vip.sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fumin Zhang, Professor
Organizational Affiliation
Ethics Committee of the First Affiliated Hospital, Nanjing Medical University, Jiangsu Province Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangsu province hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yueming Sun

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Laparoscopic Right Hemicoloectomy for Right Colon Cancer With a Medial-to-lateral Approach Orientated by SMA or SMV

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