Hepatic Flexure Colon CancerLISHNCT04479111
Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon
A study testing laparoscopic ileocecus-sparing right hemicolectomy in people with Hepatic Flexure Colon Cancer and Proximal Transverse Colon Cancer, run by Zhejiang University at 1 site in China.
Trial summary
To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Flexure Colon Cancer, Proximal Transverse Colon Cancer
- What is being tested?
- laparoscopic ileocecus-sparing right hemicolectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 1 Jan 2023
- 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 suitable for curative surgery 18-75years old
- ASA grade I-III
- Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
- Localization diagnosis: the tumor located at hepatic flexure and proximal transverse colon(proximal to the right branch of middle colic artery);
- Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T1-T4N0 or TanyN+; there is no distant metastasis.
- Intraoperative measurement: the distance between colic branch of ileocolic artery and proximal edge of the tumor should be longer than 5cm.
- Informed consent
Who cannot join
- Simultaneous or metachronous multiple primary colorectal cancer;
- History of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
- Preoperative imaging examination results show: fused lymph node at the root of ileocolic artery.
- Distant metastasis.
- History of any other malignant tumor in recent 5 years.
- Patients need emergency operation.
- Not suitable for laparoscopic surgery (i.e., extensive adhesion caused by abdominal surgery, not suitable for artificial pneumoperitoneum, etc).
- Informed consent refusal
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University
Hangzhou, Zhejiang, 310000
About this study
Official title: An Open, Single-arm, Single Center, Clinical Trial to Investigate the Feasibility and Safety of Laparoscopic Ileocecus-sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon
To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe
Read the detailed description
Our study is a single arm, single center clinical trial. The enrolled patients will accept laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative complications, 1-year local recurrence. The second endpoint: conversion to conventional right hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year disease free survival, R0 resection, Specimen morphometry
- Being tested
- laparoscopic ileocecus-sparing right hemicolectomy
- Keywords
- hepatic flexure colon cancer, proximal transverse colon cancer, ileocecus-sparing, laparoscopic right hemicolectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic ileocecus-sparing right hemicolectomyProcedure or surgery
The ileocecal artery(ICA) is skeletonized. The colic branch of ICA is divided and ligated. Preserve anterior cecal artery, posterior cecal artery and ileocecal branch of ICA. Divide and ligate the right colic artery(RCA) and middle colic artery(MCA) at their roots. Dissect the lymph nodes surrounding the ICA, RCA and MCA accordingly. Head-to-Head colocolic anastomois is done, with circular stapler via making an opening at the bottom of cecum.
| Study group | Role | What they receive |
|---|---|---|
| LISRH group | Experimental | Following the principle of complete mesocolic excision(CME), Ileocecus-Sparing Right colectomy refers to the resection of the most portion of the ascending colon, hepatic flexure and mid to distal transverse colon. The extent of lymph node dissection and length of distal resection margin are similar to conventional right hemicolectomy. The length of proximal resection margin varies. Receives: Procedure: laparoscopic ileocecus-sparing right hemicolectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded
Measured: up to 90 days after surgery
1-year local recurrence
rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein,
Measured: 7 days after surgery
Secondary outcomes (6)
Conversion to conventional right hemicolectomy
the rate of conversion to conventional right hemicolectomy
Measured: 1 day of surgery
Time to first flatus after surgery
days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery
Measured: up to 7 days after surgery
Number of harvested lymph nodes
Number of harvested Lymph nodes according to the pathological report
Measured: up to 1 week after surgery
R0 resection
Rate of resection without any affected margins during the surgical procedure according to the pathological report
Measured: up to 1 week after surgery
Specimen morphometry
The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length
Measured: within 30 days
3-year disease free survival
the time from enrollment until disease relapse or death from any cause 3 years after surgery
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start1 Jan 2020
- Primary completion30 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Flexure Colon CancerStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ding Ke-Feng, Zhejiang University
- Investigators
- KeFeng Ding, PhD, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04479111
- Sponsor's protocol ID
- CRCCZ-S02
- Acronym
- LISH
- Status last verified
- Feb 2023
- First submitted
- 16 Jul 2020
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Single-arm, Single Center, Clinical Trial to Investigate the Feasibility and Safety of Laparoscopic Ileocecus-sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon
- ClinicalTrials.gov ID
- NCT04479111
- Acronym / sponsor ID
- LISH / CRCCZ-S02
- Keywords
- hepatic flexure colon cancer, proximal transverse colon cancer, ileocecus-sparing, laparoscopic right hemicolectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe
Detailed description
Our study is a single arm, single center clinical trial. The enrolled patients will accept laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative complications, 1-year local recurrence. The second endpoint: conversion to conventional right hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year disease free survival, R0 resection, Specimen morphometry
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LISRH group | Experimental | Procedure: laparoscopic ileocecus-sparing right hemicolectomyFollowing the principle of complete mesocolic excision(CME), Ileocecus-Sparing Right colectomy refers to the resection of the most portion of the ascending colon, hepatic flexure and mid to distal transverse colon. The extent of lymph node dissection and length of distal resection margin are similar to conventional right hemicolectomy. The length of proximal resection margin varies. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients suitable for curative surgery 18-75years old
- ASA grade I-III
- Qualitative diagnosis: a pathological diagnosis of adenocarcinoma;
- Localization diagnosis: the tumor located at hepatic flexure and proximal transverse colon(proximal to the right branch of middle colic artery);
- Enhanced CT scan of chest, abdominal and pelvic cavity: assessment of tumor stage is T1-T4N0 or TanyN+; there is no distant metastasis.
Key exclusion criteria (8 listed)
- Simultaneous or metachronous multiple primary colorectal cancer;
- History of familial adenomatous polyposis, ulcerative colitis or Crohn's disease.
- Preoperative imaging examination results show: fused lymph node at the root of ileocolic artery.
- Distant metastasis.
- History of any other malignant tumor in recent 5 years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laparoscopic ileocecus-sparing right hemicolectomyThe ileocecal artery(ICA) is skeletonized. The colic branch of ICA is divided and ligated. Preserve anterior cecal artery, posterior cecal artery and ileocecal branch of ICA. Divide and ligate the right colic artery(RCA) and middle colic artery(MCA) at their roots. Dissect the lymph nodes surrounding the ICA, RCA and MCA accordingly. Head-to-Head colocolic anastomois is done, with circular stapler via making an opening at the bottom of cecum. | Procedure or surgery | LISRH group |
Primary outcome
Postoperative complications
Time frame: up to 90 days after surgery
Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded
1-year local recurrence
Time frame: 7 days after surgery
rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein,
6 secondary outcomes
Conversion to conventional right hemicolectomy
Time frame: 1 day of surgery
Time to first flatus after surgery
Time frame: up to 7 days after surgery
Number of harvested lymph nodes
Time frame: up to 1 week after surgery
R0 resection
Time frame: up to 1 week after surgery
Specimen morphometry
Time frame: within 30 days
3-year disease free survival
Time frame: 3 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
KeFeng Ding, PhD principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic ileocecus-sparing right hemicolectomy in people with Hepatic Flexure Colon Cancer and Proximal Transverse Colon Cancer, run by Zhejiang University at 1 site in China.
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 8 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: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative complications (time frame: up to 90 days after surgery). 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 8 Feb 2023.