Evaluation the Safety of Indocyanine Green Guided Treatment of Henle Trunk — SIGHELC  

Surgery Clinical Trial

Official title: Evaluation the Safety of Indocyanine Green Guided Treatment of Henle Trunk Using Endoscopic Linear Stapler in Laparoscopic Radial Hemicolectomy of Colon Cancer -- a Prospective Randomized Controlled Multicenter Clinical Study (SIGHELC)

Status Not yet recruiting

Clinical Trial Summary

Laparoscopic right hemicolectomy D3 dissection or complete mesocolic excision (CME) has become the standard treatment for right hemi-colon cancer, and the treatment of Henle trunk is one of the difficulties of the operation. However, there are many variations in the Henle trunk, and the vein wall is thin. It is very easy to damage the Henle trunk and its branches during the operation, resulting in massive bleeding, especially for beginners. In addition, retrospective studies found that for ileocecal or ascending colon tumors, low ligation of Henle trunk can obtain better lymph node clearance. In the early stage, the investigators improved the surgical method for ileocecal or ascending colon tumors. An endoscopic linear stapler was used to disconnect the surrounding tissues of Henle trunk under the guidance of indocyanine green developer. The retrospective study of small samples found that it can significantly reduce the incidence of local bleeding, shorten the operation time, and obtain the same lymph node clearance rate. At present, there is less large-scale randomized controlled study on the disconnection of Henle trunk with linear stapler for right colon cancer. In recent years, the were nearly 1000 cases/year of colorectal cancer operated in department of gastrointestinal surgery of shanghai east hospital. Therefore, the investigators plan to cooperate with many domestic colorectal cancer treatment centers to take the lead in carrying out this prospective, multicenter and randomized controlled trail, to explore the safety and efficacy of linear stapler in the treatment of Henle trunk in laparoscopic radial hemicolectomy of colon cancer. The investigators hope to provide accurate clinical evidence for individualized precision treatment of rectal cancer patients.

Clinical Trial Description

Laparoscopic right hemicolectomy D3 dissection or complete mesocolic excision (CME) has become the standard treatment for right hemi-colon cancer, and the treatment of Henle's trunk is one of the difficulties of the operation. The traditional view is that D3 lymph node dissection should be performed routinely in the right hemicolectomy, that is, the blood vessels of the right hemi-colon including the Henle trunk and its tributary should be ligated at the level of superior mesenteric artery and vein, and the lymph nodes should be cleaned. However, there is a large degree of variation in the anatomy of Henle trunk, which is even considered as the "fingerprint" of CME in the right colon. Coupled with the thin venous wall, it is very easy to damage Henle trunk and its branches during operation and resulting in massive bleeding, especially for beginners. In addition, a retrospective study found that the lymph node metastasis rate around the middle colonic vein and Henle trunk was less than 5% in ileocecal or ascending colon tumors. Low ligation in this area can also obtain a better lymph node resection rate.

Based on the above points, the investigators propose to improve the surgical method in ileocecal or ascending colon tumors using a combined cephalic caudal approach. When the accessory right colonic vein is separated from the head and then turned to the caudal side for upward dissociation. After no metastasis of 203 groups of lymph nodes is confirmed according to indocyanine green (ICG) development during the operation, the Henle trunk and its root tissue were resected with a linear stapler. The investigators believe that this method has the following advantages: 1. The Henle trunk together with the branches could be effectively disconnect, which can reduce the difficulty of operation and shorten the learning curve; 2. The incidence of bleeding was reduced. Our preliminary small sample studies have confirmed that the improved operation does not increase postoperative complications and can obtain the same oncological prognosis.

This is a prospective, multicenter, randomized, parallel controlled trial designed to evaluate the safety and efficacy of linear stapler in laparoscopic radical resection of ascending colon cancer. The total number of patients enrolled in this study is 128, including 64 in the control group and 64 in the experimental group. In the experimental group, indocyanine green was injected for development during the operation after ileocolic vessel and the middle colonic vessel were dissected. The tributary vessels of the Henle trunk were disconnected with a linear stapler if there was no obvious lymph node development, which means ligated not in the root. Otherwise, they were transferred to the experimental group. In the control group, the branches of Henle's trunk were dissected according to the conventional method and clamped at the root. The main research objectives include: 1. Intraoperative bleeding volume 2. Operation time. Secondary research objectives included: 1. Lymph node detection rate 2. R0 resection rate 3. Complication rate 4. At least one serious complication rate within 30 days after resection.

At present, there is less large-scale randomized controlled study on the disconnection of Henle trunk with linear stapler for right colon cancer. In recent years, the were nearly 1000 cases/year of colorectal cancer operated in department of gastrointestinal surgery of shanghai east hospital. Therefore, the investigators plan to cooperate with many domestic colorectal cancer treatment centers to take the lead in carrying out this prospective, multicenter and randomized controlled trail, to explore the safety and efficacy of linear stapler in the treatment of Henle trunk in laparoscopic radial hemicolectomy of colon cancer. The investigators hope to provide accurate clinical evidence for individualized precision treatment of rectal cancer patients. ;

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Surgery

• NCT number: NCT05125393
• Study type: Interventional
• Source: Shanghai East Hospital
• Contact: Xiaohua Jiang, Doctor
• Phone: 86-021-38804518
• Email: jiangxiaohuash@163.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2021
• Completion date: September 30, 2024