NCT05125393

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

December 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2024

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

2 years

First QC Date

September 13, 2021

Last Update Submit

November 7, 2021

Conditions

Colon CancerSurgery

Keywords

Colon cancerHenle trunkLinear staplerLaparoscopic surgery

Outcome Measures

Primary Outcomes (2)

  • Intraoperative bleeding

    The total amount of bleeding during the operation, that is, the total amount of blood loss in the drainage bottle and gauze

    From the beginning to the end of the operation

  • Operation time

    Time from start to end of operation

    From the beginning to the end of the operation

Secondary Outcomes (4)

  • Number of lymph nodes dissected

    7 days after operation

  • R0 resection rate

    7 days after operation

  • Incidence of complications

    within 30 days after resection

  • Incidence of at least one serious complication within 30 days after resection

    within 30 days after resection

Study Arms (2)

Linear stapler group

EXPERIMENTAL

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.

Procedure: Laparoscopic linear stapler

Conventional group

NO INTERVENTION

The branches of Henle trunk were dissected according to the conventional method and clamped at the root.

Interventions

Laparoscopic linear staplerPROCEDURE

The ileocecal or ascending colon tumors were resected 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 ICG development during the operation, the Henle stem and its root tissue were resected with a linear stapler.

Linear stapler group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with locally advanced colorectal cancer met the following criteria at the time of enrollment:
  • Adult male and female, aged between 18-75 years
  • Colonoscopic biopsy confirmed colonic adenocarcinoma
  • Before treatment, the tumor was located between ileocecal part and ascending colon liver area
  • There were no local complications (no complete obstruction, no massive active bleeding, no perforation and abscess formation) before operation
  • The functions of heart, lung, liver and kidney meet the requirements of operation and anesthesia
  • Informed consent form be signed

You may not qualify if:

  • Previous history of malignant colorectal tumor
  • Patients with intestinal obstruction, intestinal perforation and intestinal bleeding requiring emergency surgery
  • The primary tumor invades the abdominal wall and / or adjacent organs, resulting in inability to R0 resection
  • Unresectable lymph node metastasis
  • Recent diagnosis complicated with other malignant tumors
  • Patients who had participated or were participating in other clinical trials within 4 weeks before enrollment
  • 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)
  • Patients with severe liver and kidney function, cardiopulmonary function, coagulation dysfunction or combined with serious basic diseases can not tolerate the operation
  • Have a history of serious mental illness
  • Pregnant or lactating women
  • Patients with uncontrolled infection before operation
  • Some researchers believe that patients with other clinical and laboratory conditions should not participate in the trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Xiaohua Jiang, Doctor

    Shanghai East Hospital

    STUDY CHAIR

Central Study Contacts

Xiaohua Jiang, Doctor

CONTACT

86-021-38804518jiangxiaohuash@163.com

Tao Du, Doctor

CONTACT

86-021-38804518sfgidt1982@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2021

First Posted

November 18, 2021

Study Start

December 1, 2021

Primary Completion

December 1, 2023

Study Completion

September 30, 2024

Last Updated

November 18, 2021

Record last verified: 2021-11