LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

Hepatic Flexure Colon Cancer Clinical Trial

Official title:

Laparoscopic Ileocecal-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon -- A Prospective, Multicenter Randomized Control Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923255
• Other study ID #: CRCCZ-S03
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2023
• Est. completion date: May 14, 2031

Study information

• Verified date: March 2024
• Source: Zhejiang University
• Contact: Kefeng Ding, PhD
• Phone: 86-571-87784720
• Email: dingkefeng[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the long-term outcomes of Laparoscopic Ileocecal-Sparing Right Hemicolectomy(LISH) compared to traditional laparoscopic right hemicolectomy(TRH) in the treatment of hepatic flexure colon cancer and proximal transverse colon cancer.

Description:

This study is a prospective, multicenter, open-labeled, randomized controlled clinical trial. The enrolled patients will be randomly assigned to either the LISH or TRH group in a 1:1 ratio and will receive the corresponding surgery. The primary endpoint: 3-year disease free survival. The second endpoint: (1)90-day postoperative complications; (2)Pathology-related indicators, including positive margin rate, number of harvested lymph nodes and lymph node metastasis rate;(3) 5-year overall survival rate (OS)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 568
• Est. completion date: May 14, 2031
• Est. primary completion date: May 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Age between 18-75 years old

2. ASA classification =III

3. Colon adenocarcinoma confirmed by endoscopy and pathological biopsy

4. Enhanced abdominal CT indicating the primary lesion is located in the hepatic flexure of the colon or proximal transverse colon (proximal 1/3 of the transverse colon)

5. Preoperative clinical staging: TanyNanyM0

6. Patients able to understand the study protocol, willing to participate in the research, and providing written informed consent

Exclusion Criteria:

1. Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection

2. Preoperative imaging or intraoperative exploration reveals: 1) tumor involving surrounding organs requiring combined organ resection; 2) presence of distant metastasis; 3) inability to perform R0 resection; 4) fused and fixed lymph nodes at the root of the ileocolic vessels

3. Additional radical surgery following Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) procedures

4. History of any other malignant tumor within the last 5 years or familial adenomatous polyposis, except for cured in situ cervical cancer, basal cell carcinoma, papillary thyroid carcinoma, or skin squamous cell carcinoma

5. Presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery

6. Patients unsuitable for or unable to tolerate laparoscopic surgery

7. Pregnant or lactating women

8. Patients with a history of psychiatric disorders

9. Patients who have received neoadjuvant therapy prior to surgery

10. Patients deemed unsuitable for the study by MDT discussion

11. Patients unable to understand the study's conditions and objectives, and refusing to sign informed consent.

Related Conditions & MeSH terms

• Colonic Neoplasms
• Hepatic Flexure Colon Cancer
• Proximal Transverse Colon Cancer

Intervention

Procedure:
• LISH (Laparoscopic Ileocecal-Sparing Right Hemicolectomy)
Preserve the ileocolic blood vessels, and perform dissection of lymph node groups 203, 202, and 201d along the root of ICV(Ileocolic artery)/ICA(Ileocolic vein). Group 201d lymph nodes are defined as the distal lymph nodes of the ileocolic vessels (colonic branch). Use an intracavitary cutting and sealing device to transect the proximal colon along the predetermined margin, and transect the transverse colon at 10cm distal to the tumor. Perform ileocecal-transverse colonic anastomosis.
• TRH(Traditional Laparoscopic Right Hemicolectomy)
Transect the root of the ileocolic vessels and perform dissection of lymph node groups 203, 202, and 201; sever the roots of the right colic and middle colic vessels, and clear the surrounding lymphoadipose tissue (lymph node groups 211/212/213 and 221/222/223). Transect the transverse colon 10cm distal to the tumor and cut the terminal ileum 10cm from the ileocecal junction. Perform ileum-to-transverse colon anastomosis.

Locations

Country	Name	City	State
China	Beijing Cancer Hospital	Beijing	Beijing
China	Cancer Hospital Academy of medicine Scenice	Beijing	Beijing
China	Peking Union Medical College Hospital	Beijing	Beijing
China	the First Affiliated Hospital of Bengbu Medical Collage	Bengbu	Anhui
China	Hunan Cancer Hospital	Changsha	Hunan
China	Sichuan Cancer Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuang University	Chengdu	Sichuan
China	the First Affiliated Hospital of Chongqing Medical Collage	Chongqing	Chongqing
China	Fujian Cancer Hospital	Fuzhou	Fujian
China	Fujian Hospital Medical Union University	Fuzhou	Fujian
China	Sun Yat-sen Memorial Hospital, Sun Yat-sen University	Guangzhou
China	The sixth Affiliated Hospital, Sun Yat-sen University	Guangzhou	Guangzhou
China	Second Affiliated Hospital Zhejiang University College of Medicine	Hangzhou	Zhejiang
China	Sir Run Run Shaw Hospital, Zhejiang University School of medicien	Hangzhou	Zhejiang
China	The First Affiliated Hospital, Zhejiang University school of Medicine	Hangzhou	Zhejiang
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang
China	Jinhua Municipal Central Hospital	Jinhua	Zhejiang
China	Yunan Cancer Hospital	Kunming	Yunnan
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu province hospital	Nanjing	Jiangsu
China	Nanjing Drum Tower Hospital	Nanjing	Jiangsu
China	Ningbo No.2 Hospital	Ningbo	Zhejiang
China	Changhai Hospital of Shanghai	Shanghai	Shanghai
China	Fudan University Shanghai Cancer Center	Shanghai	Shanghai
China	Renji Hospital Affiliated of The Shanghai Jiao Tong University Medical School	Shanghai	Shanghai
China	Ruijin Hospital Affiliated of The Shanghai Jiao Tong University Medical School	Shanghai	Shanghai
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog	Wuhan	Hubei
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	The Cancer Hospital Affiliated of The Xingjiang University Medical School	Xinjiang	Xinjiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival	the time from enrollment until disease relapse or death from any cause 3 years after surgery	3 years
Secondary	Postoperative complications	Complications occurring within 30 days after surgery, classified according to the Clavien-Dindo system, including intraoperative, short-term, and long-term postoperative complications.Index (CCI) will be recorded	up to 30 days after surgery
Secondary	Metastasis rate of harvested lymph nodes	according to the pathological report	up to 2 weeks after surgery
Secondary	Quality of CME (complete mesocolic excision)	After the specimen had been harvested, photographs of the anterior and posterior aspects of the specimens were uploaded to the electronic data capture system. On the basis of the anterior and posterior photographs, the specimens were classified into three groups of the quality of CME: grade I, intact mesocolon; grade II laceration in the mesocolon; and grade III laceration in the mesocolon reaching the bowel.	up to 2 weeks after surgery
Secondary	Length of resected specimen	On the basis of the anterior and posterior photographs, the length of resected specimen were measured.	up to 2 weeks after surgery
Secondary	Resection margins distance	On the basis of the anterior and posterior photographs, the distal and proximal resection margins distance of the resected intestinal specimen were measured.	up to 2 weeks after surgery
Secondary	Vascular pedicle length of resected specimen	On the basis of the anterior and posterior photographs, the vascular pedicle length of the resected intestinal specimen were measured.	up to 2 weeks after surgery
Secondary	Positive margin rate	positive margin rate of resected specimen according to the pathological report	up to 2 weeks after surgery
Secondary	Incidence rates of polyps	the incidence rates of polyps as seen on colonoscopy at 1, 3 and 5 years after surgery respectively.	5 years
Secondary	Incidence rates of adenomas	the incidence rates of adenomas as seen on colonoscopy at 1, 3 and 5 years after surgery respectively.	5 years
Secondary	Scores from the Gastrointestinal Symptom Rating Scale (GSRS)	scores from the Gastrointestinal Symptom Rating Scale (GSRS) at 1, 2, and 3 years after surgery respectively.	3 years
Secondary	Scores from the EQ-5D-5L Quality of Life Scale	scores from the EQ-5D-5L Quality of Life Scale at 1, 2, and 3 years after surgery respectively.	3 years
Secondary	5-year overall survival rate (OS)	The proportion of patients who survived 5 years after surgery, taking into account any cause of death.	5 years