Clinical trial · Interventional
Evaluation the Safety of Indocyanine Green Guided Treatment of Henle Trunk
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic linear stapler | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Linear stapler group
- description
- 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.
- interventionNames
- Procedure: Laparoscopic linear stapler
- type
- NO_INTERVENTION
- label
- Conventional group
- description
- The branches of Henle trunk were dissected according to the conventional method and clamped at the root.
Primary outcomes (2)
- measure
- Intraoperative bleeding
- timeFrame
- From the beginning to the end of the operation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with locally advanced colorectal cancer met the following criteria at the time of enrollment: 1. Adult male and female, aged between 18-75 years 2. Colonoscopic biopsy confirmed colonic adenocarcinoma 3. Before treatment, the tumor was located between ileocecal part and ascending colon liver area 4. There were no local complications (no complete obstruction, no massive active bleeding, no perforation and abscess formation) before operation 5. The functions of heart, lung, liver and kidney meet the requirements of operation and anesthesia 6. Informed consent form be signed Exclusion Criteria: * Patients who met the following criteria at the time of inclusion were excluded from this trial: 1. Previous history of malignant colorectal tumor 2. Patients with intestinal obstruction, intestinal perforation and intestinal bleeding requiring emergency surgery 3. The primary tumor invades the abdominal wall and / or adjacent organs, resulting in inability to R0 resection 4. Unresectable lymph node metastasis 5. Recent diagnosis complicated with other malignant tumors 6. Patients who had participated or were participating in other clinical trials within 4 weeks before enrollment 7. American Society of Anesthesiologists (ASA) physical status classes ≥ grade IV and / or Eastern Cooperative Oncology Group (ECOG) physical state score ≥ 2 points (see Appendix for details) 8. Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases can not tolerate the operation 9. Have a history of serious mental illness 10. Pregnant or lactating women 11. Patients with uncontrolled infection before operation 12. Some researchers believe that patients with other clinical and laboratory conditions should not participate in the trial
References
Publications (0)
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