Colon Rectal ResectionPhase 4NCT00887497
Ischemic Conditioning (Delay Phenomenon) in Colorectal Surgery
A Phase 4 study testing Angioembolization in people with Colon Rectal Resection, run by University of California, Irvine at 1 site in United States.
Trial summary
One of the major complications of surgical excision of colorectal cancer includes improper healing of the anastomosis (reconnection of the remaining, cancer free intestine). This can result in anastomotic leak, abscess then abdominal and/or pelvic sepsis and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Rectal Resection
- What is being tested?
- Angioembolization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jun 2011
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are at least 18 years of age, male or female
- Are scheduled for a non-emergent, resection of your colon
- Are able to give written informed consent to indicate an understanding of the study procedures.
Who cannot join
- Will be undergoing an emergency procedure or has a diagnosis of bowel complication(s) such as bowel obstruction, constriction, inflammation, infection, or have inflammatory bowel disease.
- Are currently participating in another clinical trial which may affect this study's outcomes.
- Have been taking regular steroid medication.
- Have a negative reaction to general anesthesia.
- Have severe arterial occlusive disease (disease of the blood vessels affecting blood flow to your legs).
- Have an abdominal aortic aneurysm (dilation of the large artery in your abdomen).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Irvine Medical Center
Orange, California, 92868
About this study
One of the major complications of surgical excision of colorectal cancer includes improper healing of the anastomosis (reconnection of the remaining, cancer free intestine). This can result in anastomotic leak, abscess then abdominal and/or pelvic sepsis and mortality.
Esophageal surgery has suffered from complications. Recently, an innovation in esophageal surgery has seen a relatively drastic decrease in complications during distal esophagectomies using a technique called "ischemic conditioning". This technique involves dividing the blood supply to the stomach that would be performed during a 1-stage esophagectomy but returning days later to complete the resection. Bench results have shown improved angiogenesis, vasodilation, less anastomotic collagen deposition and minimized ischemia at the time of surgery while clinical results have included improved stricture rates, leak rates and mortality in esophageal surgery.
Read more
Hypothesis Ischemic conditioning is universal to the intestinal tract and a similar technique can be applied in colon and rectal surgery. The investigators plan evaluating this hypothesis by performing a pilot study comprised of the following: performing an endovascular embolization of the inferior mesenteric artery (IMA) followed by interval laparoscopic or open rectosigmoid resection.
Methods Part 1 - Endovascular Procedure Patients will be admitted and undergo endovascular embolization of their IMA as an outpatient following diagnostic angiography. They will undergo sigmoidoscopy throughout the embolization and a laser probe will indirectly measure tissue oxygenation. The patient will be released home that day.
Part 2 - Colorectal Procedure Patients will then return 2-4 days later for their definitive laparoscopic or open rectosigmoid resection. They will undergo sigmoidoscopy before and after surgery and a laser probe will indirectly measure tissue oxygenation. The patient will then be released home on average 3-5 days later.
Read the detailed description
This study is designed to evaluate the safety and feasibility of ischemic conditioning of the colon prior to resection. Colon and rectal resections require the removal of a section of colon or rectum with re-attachment (anastomosis) of the two ends. This joining together of the intestine is at risk for leaking if healing does not occur appropriately. Factors postulated to lead to anastomotic leak include ischemia as well as tension and infection among others.
The concept of ischemic conditioning is based upon the innate ability to compensate and increase the blood flow to a section of the intestine which is locally ischemic. By inducing ischemia to a segment of intestine prior to resection, one could theoretically increase blood flow via collateral vessels prior to resection. This would then, in turn, lead to more initial blood flow to an anastomosis at the time of surgery via these collaterals, thereby decreasing ischemia to a new, healing anastomosis.
Ischemic conditioning was first described in animal models proving its safety and efficacy. In the rat model, ischemic conditioning demonstrated a return to baseline of tissue perfusion by the time of resection, improved anastomotic leak rate and higher anastomotic wound breaking strength. The first time this idea was implemented in the human model was in a study by Akiyama et. al. where preoperative embolization was shown to be safe and improved blood supply to the distal end of anastomosis after esophagectomy (remaining stomach). Further basic science studies have shown improved angiogenesis, vasodilation, less anastomotic collagen deposition and minimized ischemic injury. Further clinical studies demonstrated improved stricture rates (0% from 40%), leak rates (0-6% from 5-15%) and mortality (0% from 5-10%).
One of the major complications in colon and rectal surgery is improper healing of the anastomosis (connection between the remaining, cancer free rectum with the remaining colon). This results in an anastomotic leak or dehiscence leading to abscess, abdominal sepsis requiring longer hospital stays, IV antibiotics, reoperation or possibly even death. It can also lead to the late complication of stricture impairing function and often requiring repeat dilations or operative revision. Recent reviews show rates of anastomotic complications in upper rectal resection at 8-17% for leaks, and an average hospital stay of 10 days.
In the current study, preoperative embolization of the Inferior Mesenteric Artery (IMA) is performed for patients scheduled to undergo colon or rectal resection. The surgery is then performed in the standard fashion (either laparoscopically or open) several days later (1-5 days). The study is designed as a prospective, non-randomized, safety (pilot) study. Since there are no reports of performing this exact procedure, we feel it is necessary to initially proceed with safety study without a comparative arm prior to a large scale, multicenter trial evaluating outcomes. Therefore, in this study we will not be evaluating morbidity or mortality outcomes to any statistical significance.
- Conditions
- Colon Rectal Resection
- Being tested
- Angioembolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AngioembolizationProcedure or surgery
Angioembolization
| Study group | Role | What they receive |
|---|---|---|
| Catheterization | Experimental | Patients receive angioembolization prior to surgery Receives: Procedure: Angioembolization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any adverse even (safety study)
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: terminated due to failure to enroll patients after two years of approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Rectal ResectionStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven D Mills, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00887497
- Sponsor's protocol ID
- 2008-6618
- Status last verified
- Sep 2011
- First submitted
- 22 Apr 2009
- Last updated
- 28 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ischemic Conditioning (Delay Phenomenon) in Colorectal Surgery
- ClinicalTrials.gov ID
- NCT00887497
- Acronym / sponsor ID
- 2008-6618
- Conditions
- Colon Rectal Resection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: terminated due to failure to enroll patients after two years of approval
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 24 Apr 2009 (estimated)
- 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.
One of the major complications of surgical excision of colorectal cancer includes improper healing of the anastomosis (reconnection of the remaining, cancer free intestine). This can result in anastomotic leak, abscess then abdominal and/or pelvic sepsis and mortality.
Esophageal surgery has suffered from complications. Recently, an innovation in esophageal surgery has seen a relatively drastic decrease in complications during distal esophagectomies using a technique called "ischemic conditioning". This technique involves dividing the blood supply to the stomach that would be performed during a 1-stage esophagectomy but returning days later to complete the resection. Bench results have shown improved angiogenesis, vasodilation, less anastomotic collagen deposition and minimized ischemia at the time of surgery while clinical results have included improved stricture rates, leak rates and mortality in esophageal surgery.
Hypothesis Ischemic conditioning is universal to the intestinal tract and a similar technique can be applied in colon and rectal surgery. The investigators plan evaluating this hypothesis by performing a pilot study comprised of the following: performing an endovascular embolization of the inferior mesenteric artery (IMA) followed by interval laparoscopic or open rectosigmoid resection.
Methods Part 1 - Endovascular Procedure Patients will be admitted and undergo endovascular embolization of their IMA as an outpatient following diagnostic angiography. They will undergo sigmoidoscopy throughout the embolization and a laser probe will indirectly measure tissue oxygenation. The patient will be released home that day.
Part 2 - Colorectal Procedure Patients will then return 2-4 days later for their definitive laparoscopic or open rectosigmoid resection. They will undergo sigmoidoscopy before and after surgery and a laser probe will indirectly measure tissue oxygenation. The patient will then be released home on average 3-5 days later.
Detailed description
This study is designed to evaluate the safety and feasibility of ischemic conditioning of the colon prior to resection. Colon and rectal resections require the removal of a section of colon or rectum with re-attachment (anastomosis) of the two ends. This joining together of the intestine is at risk for leaking if healing does not occur appropriately. Factors postulated to lead to anastomotic leak include ischemia as well as tension and infection among others.
The concept of ischemic conditioning is based upon the innate ability to compensate and increase the blood flow to a section of the intestine which is locally ischemic. By inducing ischemia to a segment of intestine prior to resection, one could theoretically increase blood flow via collateral vessels prior to resection. This would then, in turn, lead to more initial blood flow to an anastomosis at the time of surgery via these collaterals, thereby decreasing ischemia to a new, healing anastomosis.
Ischemic conditioning was first described in animal models proving its safety and efficacy. In the rat model, ischemic conditioning demonstrated a return to baseline of tissue perfusion by the time of resection, improved anastomotic leak rate and higher anastomotic wound breaking strength. The first time this idea was implemented in the human model was in a study by Akiyama et. al. where preoperative embolization was shown to be safe and improved blood supply to the distal end of anastomosis after esophagectomy (remaining stomach). Further basic science studies have shown improved angiogenesis, vasodilation, less anastomotic collagen deposition and minimized ischemic injury. Further clinical studies demonstrated improved stricture rates (0% from 40%), leak rates (0-6% from 5-15%) and mortality (0% from 5-10%).
One of the major complications in colon and rectal surgery is improper healing of the anastomosis (connection between the remaining, cancer free rectum with the remaining colon). This results in an anastomotic leak or dehiscence leading to abscess, abdominal sepsis requiring longer hospital stays, IV antibiotics, reoperation or possibly even death. It can also lead to the late complication of stricture impairing function and often requiring repeat dilations or operative revision. Recent reviews show rates of anastomotic complications in upper rectal resection at 8-17% for leaks, and an average hospital stay of 10 days.
In the current study, preoperative embolization of the Inferior Mesenteric Artery (IMA) is performed for patients scheduled to undergo colon or rectal resection. The surgery is then performed in the standard fashion (either laparoscopically or open) several days later (1-5 days). The study is designed as a prospective, non-randomized, safety (pilot) study. Since there are no reports of performing this exact procedure, we feel it is necessary to initially proceed with safety study without a comparative arm prior to a large scale, multicenter trial evaluating outcomes. Therefore, in this study we will not be evaluating morbidity or mortality outcomes to any statistical significance.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheterization | Experimental | Procedure: AngioembolizationPatients receive angioembolization prior to surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Are at least 18 years of age, male or female
- Are scheduled for a non-emergent, resection of your colon
- Are able to give written informed consent to indicate an understanding of the study procedures.
Key exclusion criteria (6 listed)
- Will be undergoing an emergency procedure or has a diagnosis of bowel complication(s) such as bowel obstruction, constriction, inflammation, infection, or have inflammatory bowel disease.
- Are currently participating in another clinical trial which may affect this study's outcomes.
- Have been taking regular steroid medication.
- Have a negative reaction to general anesthesia.
- Have severe arterial occlusive disease (disease of the blood vessels affecting blood flow to your legs).
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 |
|---|---|---|
| AngioembolizationAngioembolization | Procedure or surgery | Catheterization |
Primary outcome
Any adverse even (safety study)
Time frame: 6-12 months
Results and safety
The study was stopped early (reason given: terminated due to failure to enroll patients after two years of approval). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2011.
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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.
Steven D Mills, MD principal investigator
University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Angioembolization in people with Colon Rectal Resection, run by University of California, Irvine at 1 site in United States.
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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 28 Sep 2011. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: terminated due to failure to enroll patients after two years of approval). Results are not available in the source record.
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?
Any adverse even (safety study) (time frame: 6-12 months). 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 28 Sep 2011.