RecruitingNot ApplicableNCT05923255

LISH Trial for the Hepatic Flexure and Proximal Transverse Colon Cancer

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


Sponsor

Zhejiang University

Enrollment

568 participants

Start Date

May 14, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria6

  • Age between 18-75 years old
  • ASA classification ≤III
  • Colon adenocarcinoma confirmed by endoscopy and pathological biopsy
  • 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)
  • Preoperative clinical staging: TanyNanyM0
  • Patients able to understand the study protocol, willing to participate in the research, and providing written informed consent

Exclusion Criteria11

  • Preoperative examination indicates synchronous multiple primary colorectal cancers or other diseases requiring bowel segment resection
  • 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
  • Additional radical surgery following Endoscopic Mucosal Resection (EMR) and Endoscopic Submucosal Dissection (ESD) procedures
  • 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
  • Presence of bowel obstruction, bowel perforation, or intestinal bleeding requiring emergency surgery
  • Patients unsuitable for or unable to tolerate laparoscopic surgery
  • Pregnant or lactating women
  • Patients with a history of psychiatric disorders
  • Patients who have received neoadjuvant therapy prior to surgery
  • Patients deemed unsuitable for the study by MDT discussion
  • Patients unable to understand the study's conditions and objectives, and refusing to sign informed consent.

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Interventions

PROCEDURELISH (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.

PROCEDURETRH(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(29)

the First Affiliated Hospital of Bengbu Medical Collage

Bengbu, Anhui, China

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Cancer Hospital Academy of medicine Scenice

Beijing, Beijing Municipality, China

the First Affiliated Hospital of Chongqing Medical Collage

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

Fujian Hospital Medical Union University

Fuzhou, Fujian, China

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Guangdong Second Provincial General Hospital

Guangzhou, Guangdong, China

The Sixth Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technolog

Wuhan, Hubei, China

People's Hospital of Hunan Province

Changsha, Hunan, China

Jiangsu province hospital

Nanjing, Jiangsu, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

The Second Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Changhai Hospital of Shanghai

Shanghai, Shanghai Municipality, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Ruijin Hospital Affiliated of The Shanghai Jiao Tong University Medical School

Shanghai, Shanghai Municipality, China

The first affiliated hospital of xi'an jiaotong university

Xi’an, Shanxi, China

West China Hospital of Sichuang University

Chengdu, Sichuan, China

The Cancer Hospital Affiliated of The Xingjiang University Medical School

Xinjiang, Xinjiang, China

Yunnan Cancer Hospital

Kunming, Yunnan, 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

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Jinhua Municipal Central Hospital

Jinhua, Zhejiang, China

Ningbo No.2 Hospital

Ningbo, Zhejiang, China

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