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Ascending Colon CancerLRHCTC-1NCT02949440

A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach

A study testing the caudal-to-cranial approach and the medial-to-lateral approach in people with Ascending Colon Cancer and Ileocaecal Valve Carcinoma, run by Guangdong Provincial Hospital of Traditional Chinese Medicine at 1 site in China.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

To investigate the clinical application value of laparoscopic radical right hemicolectomy using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective randomized controlled clinical study. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
the caudal-to-cranial approach and the medial-to-lateral approach
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteChina
Study dates
Oct 2016to Dec 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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The age limits is 18-80 years old;
  • The clinical staging was II,III carcinoma of right colon，located in right-sided colon;
  • The preoperative imaging confirmed that the tumor did not involve adjacent organs;
  • American Society of anesthesiologists (ASA) score less than or equal to Level III;
  • Criteria of performance status karnofsky is greater than or equal to 60.

Who cannot join

  • The patients' age limits is Less than 18 years old, or more than 80 years old
  • The preoperative imaging confirmed that the tumor involve adjacent organs;
  • The tumor have been finding distant metastases;
  • American Society of anesthesiologists (ASA) score more than 3;
  • Criteria of performance status karnofsky is lower than 60;
  • It is the carcinoma of right colon with multiple colonic polyps Disease;
  • there is a laparoscopic surgery contraindications.

Trial locations and contacts

1 site in 1 country.

Liao-nan Zou, MD. contact

0086-020-13423663496

13423663496@163.com

China1 site, 1 recruiting

  • GI surgery,Guangdong Province Hospital of Chinese Medicine

    Guangzhou, Guangdong, 510120

    liao-nan Zou, MD, 0086-020-13423663496, 13423663496@163.com

    xin-quan Lu, MD, 0086-020-18898607919, 18898607919@163.com

    Recruiting

Other trials in China

About this study

Official title: A Prospective Randomized Controlled Clinical Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach

To investigate the clinical application value of laparoscopic radical right hemicolectomy using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective randomized controlled clinical study.

Read the detailed description

To compare the caudal-to-cranial approach with the medial-to-lateral approach in laparoscopic right hemicolectomy for the advance right colon cancer.

A prospective randomized controlled trial will be performed in the GI department,the Guangdong provincial hospital of Chinese Medicine from October 2016 to October 2024.The sample size，150 cases with advanced right colon cancer, will be needed after calculated by the statistics .The 150 cases will be randomly divided into two groups: laparoscopic radical right hemicolectomy using the caudal-to-cranial(CtC) approach(GroupCtC) and laparoscopic radical right hemicolectomy using the medial-to-lateral(MtL) approach (GroupMtL). Primary outcomes are the operative time，The secondary outcomes are the total blood loss,the number of lymph nodes dissected,the average time of ground activities,the time to first flatus,the hospital stay,the intra-operative complication and the post-operative complication，and others' outcomes are the Disease-free survival rate(DFS) at 3 years and 5 years,the Overall survival rate（OS）at 3 years and 5 years.The data in two groups will be compared.

Being tested
the caudal-to-cranial approach, the medial-to-lateral approach
Keywords
Laparoscopic right Hemicolectomy, Caudal-to-cranial Approach
Medical subject headings
Disease

What participants receive

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

  • the caudal-to-cranial approachProcedure or surgery

    Cutting the peritoneum along the line between the right mesocolon and retroperitoneum, enter the Toldt's space to dissect the posterior of Superior mesenteric vein and Superior mesenteric artery and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein. In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called the caudal-to-cranial approach.

  • the medial-to-lateral approachProcedure or surgery

    First, the pedicle of ileocolic vessels is identified and the mesocolon is dissected between the pedicle and the periphery of the Superior mesenteric vein to expose the second portion of the duodenum. The ileocolic vessels are then cut at their roots. The ascending mesocolon is separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon.This approach is the medial-to-lateral(MtL) approach

Study groups in NCT02949440
Study groupRoleWhat they receive
the caudal-to-cranial approachExperimentalCutting the peritoneum along the line between the right mesocolon and retroperitoneum, enter the Toldt's space to dissect the posterior of Superior mesenteric vein（SMV）and Superior mesenteric artery（SMA）and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein（SMV）. In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called caudal-to-cranial approach.
Receives: Procedure: the caudal-to-cranial approach
the medial-to-lateral approachActive comparatorFirst, the pedicle of ileocolic vessels is identified and the mesocolon is dissected between the pedicle and the periphery of the Superior mesenteric vein（SMV）to expose the second portion of the duodenum. The ileocolic vessels are then cut at their roots. The ascending mesocolon is separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon.This approach is the medial-to-lateral(MtL) approach
Receives: Procedure: the medial-to-lateral approach

What is being measured

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

  1. the operation time

    Measured: up to 36 months

Secondary outcomes (5)

  1. the total blood loss

    Measured: up to 36 months

  2. the number of lymph nodes dissected

    Measured: up to 36 months

  3. the average time of ground activities

    Measured: up to 36 months

  4. the time to first flatus

    Measured: up to 36 months

  5. the intra-operative complication and the post-operative complication

    Measured: up to 36 months

Timeline

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

  1. First posted31 Oct 2016 (estimated)
  2. Study startOct 2016
  3. Primary completionFeb 2020 (estimated)
  4. Study completionDec 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
Outcomes assessor
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02949440
Sponsor's protocol ID
LRHCTC-1
Acronym
LRHCTC-1
Status last verified
Oct 2016
First submitted
25 Oct 2016
Last updated
31 Oct 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Yes

Publications

  • Zou L, Xiong W, Li H, He Y, Diao D, Zheng Y, Luo L, Tan P, Wang W, Wan J. [Efficacy analysis of laparoscopic radical right hemicolectomy using caudal-to-cranial approach]. Zhonghua Wei Chang Wai Ke Za Zhi. 2015 Nov;18(11):1124-7. Chinese.

    PubMed 26616807

  • Zou L, Xiong W, Mo D, He Y, Li H, Tan P, Wang W, Wan J. Laparoscopic Radical Extended Right Hemicolectomy Using a Caudal-to-Cranial Approach. Ann Surg Oncol. 2016 Aug;23(8):2562-3. doi: 10.1245/s10434-016-5215-2. Epub 2016 Apr 12.

    PubMed 27072997

  • Li H, He Y, Lin Z, Xiong W, Diao D, Wang W, Wan J, Zou L. Laparoscopic caudal-to-cranial approach for radical lymph node dissection in right hemicolectomy. Langenbecks Arch Surg. 2016 Aug;401(5):741-6. doi: 10.1007/s00423-016-1465-5. Epub 2016 Jun 18.

    PubMed 27318491

Questions about this trial

What is this clinical trial studying?

A study testing the caudal-to-cranial approach and the medial-to-lateral approach in people with Ascending Colon Cancer and Ileocaecal Valve Carcinoma, run by Guangdong Provincial Hospital of Traditional Chinese Medicine 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 5 inclusion and 7 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 31 Oct 2016. 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?

Results are not available in the source record.

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

Contact Liao-nan Zou, MD. (0086-020-13423663496, 13423663496@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the operation time (time frame: up to 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02949440, which also lists 3 linked publications.

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 31 Oct 2016.

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