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Colon CancerSIGHELCNCT05125393

Evaluation the Safety of Indocyanine Green Guided Treatment of Henle Trunk

A study testing Laparoscopic linear stapler in people with Colon Cancer and Surgery, run by Shanghai East Hospital.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Colon Cancer, Surgery
What is being tested?
Laparoscopic linear stapler
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
No sites listed yet
Study dates
1 Dec 2021to 30 Sep 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patients who met the following criteria at the time of inclusion were excluded from this trial:
  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

No sites are listed yet.

Xiaohua Jiang, Doctor contact

86-021-38804518

jiangxiaohuash@163.com

Tao Du, Doctor contact

86-021-38804518

sfgidt1982@163.com

About this study

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)

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.

Read the detailed 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.

Being tested
Laparoscopic linear stapler
Keywords
Colon cancer, Henle trunk, Linear stapler, Laparoscopic surgery
Medical subject headings
Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Laparoscopic linear staplerProcedure or surgery

    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.

Study groups in NCT05125393
Study groupRoleWhat they receive
Linear stapler groupExperimentalIn 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.
Receives: Procedure: Laparoscopic linear stapler
Conventional groupNo interventionThe branches of Henle trunk were dissected according to the conventional method and clamped at the root.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Intraoperative bleeding

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

    Measured: From the beginning to the end of the operation

  2. Operation time

    Time from start to end of operation

    Measured: From the beginning to the end of the operation

Secondary outcomes (4)
  1. Number of lymph nodes dissected

    Number of lymph nodes dissected

    Measured: 7 days after operation

  2. R0 resection rate

    Percentage of patients with R0 resection

    Measured: 7 days after operation

  3. Incidence of complications

    Percentage of postoperative complications

    Measured: within 30 days after resection

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

    Incidence of at least one serious complication within 30 days after resection,such as Massive hemorrhage, anastomotic fistula, septic shock, death, etc.

    Measured: within 30 days after resection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2021
  2. Study start1 Dec 2021 (estimated)
  3. Primary completion1 Dec 2023 (estimated)
  4. Study completion30 Sep 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
128 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05125393
Sponsor's protocol ID
Shanghaieasthospital-2021216
Acronym
SIGHELC
Status last verified
Nov 2021
First submitted
13 Sep 2021
Last updated
18 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Laparoscopic linear stapler in people with Colon Cancer and Surgery, run by Shanghai East Hospital.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiaohua Jiang, Doctor (86-021-38804518, jiangxiaohuash@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative bleeding (time frame: From the beginning to the end of the operation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.

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