Liver DiseasePhase 4NCT00152607
Orthotopic Liver Transplantation Using a Living Donor
A Phase 4 study testing donor right hepatic lobectomy in people with Liver Disease and Liver Neoplasms, run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to: determine the safety of donor right hepatic lobectomy as a procedure to provide a liver graft for living donor liver transplantation. study the regeneration of liver tissue by volumetric testing for both donor and recipient. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Liver Disease, Liver Neoplasms
- What is being tested?
- donor right hepatic lobectomy
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2000to Sep 2006
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-55
- No current or prior history of heart, lung or other medical problems.
- No history of liver disease.
- No history of malignancy, except limited basal cell carcinoma.
- ABO / HLA compatibility with the recipient.
- If female and premenopausal, a negative pregnancy test.
Show all 9Show fewer
- Related to recipient either by blood or marriage and having a stable, long term, emotional relationship.
- The donor's body size and volumetric determination of liver mass by abdominal CT scan will indicate whether or not a donor is a suitable candidate for liver donation if the donor meets the other inclusion criteria. Favorable donors for the individual organs will be those with donor graft to recipient body dry weight ratios (GRBWR) of >0.7% and those with a ratio of graft volume to recipient's expected liver volume (GWRLW) of >35%.
- Satisfactory psychosocial evaluation. -
Who cannot join
- Recipient Exclusion Criteria:
- Pregnant or nursing females.
- Patients with significant concomitant infections.
- Patients who require multiple organ transplants.
- Significant pulmonary disease. If pulmonary disease is clinically suspected, diagnostic studies will be performed to exclude the presence of pulmonary hypertension (PA systolic pressure >40 mm Hg) or arterial saturation (Po2<60 mmHg, breathing room air).
- Patients at a higher than average perioperative risk secondary to severe decompensated liver disease or previous surgery (i.e., re-transplantation) or infections.
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Chicago Hospitals
Chicago, Illinois, 60637
About this study
Official title: Orthotopic Liver Transplantation Using a Living Donor Into An Adult Recipient
The purpose of this study is to:
determine the safety of donor right hepatic lobectomy as a procedure to provide a liver graft for living donor liver transplantation.
study the regeneration of liver tissue by volumetric testing for both donor and recipient.
assess if graft and patient survival with living donor transplantation is comparable to that of cadaveric donor transplantation.
Read the detailed description
Preoperative Evaluation of Recipients:
Recipients who consent for living donor liver transplantation will have the following measurements performed in addition to those normally performed in their pretransplant workup.
- Ideal, dry and current body weights.
- An estimation of the recipient's actual liver volume will be determined by linear CT scanning. Continuous axial-10 mm-thick slices will be obtained following IV contrast. The area of the liver will be electronically outlined on the CT console and then multiplied by the slice thickness. This measurement will be used to assess the accuracy of CT in predicting liver weight and volume by comparing it to the actual volume displacement and weight following hepatectomy.
- The expected ideal volume of the recipient liver will be calculated from the patient's body weight. Standard liver volume (ml) = 706.2 x (body surface area [m2] + 2.4. Body surface area is calculated from the following formula: BSA = Square root of (Height [inches] x Weight [lbs.]/3131). Example: A recipient who is 5'4" and weighs 121 lbs. has a body surface area of 1.58m2. Thus the estimated ideal liver volume for this recipient is 1120 cc. In order to provide adequate hepatic parenchyma for function they would require 35%-40% of this volume = 392 - 447 cc of liver tissue.
Donor Evaluation:
- Actual and ideal body weight.
- History and physical exam.
- Psychosocial evaluation of the donor will be performed by a social worker for the kidney transplant program. Since he is not affiliated with the liver program, he will be able to objectively assess the potential donor's psychosocial condition. He will continue to see the patient (donor) after the operation while hospitalized and as an outpatient once and then on a prn basis.
- Evaluations by a donor advocate physician who is not part of the transplant department. The potential donor will be interviewed alone by the physician and allowed to express reservations concerning the procedure in private. The donor advocate physician will review the donor workup in detail to ensure its appropriateness. Should the donor advocate physician indicate that the donor is unsuitable, the donor will be excluded from further evaluation.
- Donor must be in usual state of health, with normal liver function and no major pre-existing medical conditions.
- Laboratory testing to rule out concomitant disease that would exclude donation would include the following: Blood type and HLA CBC with differential, platelet count Chem 17, SGPT, GGTP, Calcium, Magnesium PT, PTT Pregnancy test for premenopausal women Hepatitis B surface antibody, hepatitis B surface antigen, hepatitis C HIV serology CXR, EKG Cardiac stress test and pulmonary function tests if indicated
- An estimation of the recipient's right and left lobe size will be determined by linear CT scanning. Continuous axial-10mm-thick slices will be obtained following IV contrast. The area of the liver will be electronically outlined on the CT console and then multiplied by the slice thickness. This measurement will be used to assess the accuracy of CT in predicting liver weight and volume by comparing it to the actual volume displacement and weight following hepatectomy in the donor.
- Hepatic arteriogram to evaluate the arterial anatomy of the liver.
- Liver biopsy.
- Informed consent.
The donor consent is a crucial ethical issue. The donor must be exceptionally well informed concerning the risks of partial hepatectomy. A more difficult element of informed consent, however, is that the donor must make a voluntary choice without coercion. In order to avoid coercion, living donor liver transplants will not be performed in emergency situations. By excluding emergent cases, time to fully consider both the experimental option of living donor transplantation and the standard option of cadaveric donor transplantation will be afforded.
The potential donor will be medically evaluated by an independent (non-study related) physician prior to any consideration of hepatectomy. Karen Kim, M.D., and Sunanda Kane, M.D., both in the section of gastroenterology, will be the donor physician/advocates. We feel that their knowledge of gastroenterology is necessary given the nature of the contemplated surgery, hepatic lobectomy. However, neither of them have affiliations to the liver transplant team, either clinical or research. These physicians will not know the potential recipient's status, will be the final arbiter of the donor's suitability, and will serve as the donor's advocate throughout the transplantation process.
The donor and recipient will both undergo psychosocial evaluation prior to the procedure. This will be to determine psychological suitability for living donor transplantation and to explore personal and family support resources. These interviews will allow both the potential donor and recipient an opportunity to express reluctance to proceed with an individual not directly involved with the transplant procedure. Perhaps the most coercive element for a potential living donor is the perception that it is the expectation of the recipient's family that one should volunteer to donate. This element of coercion can be minimized by allowing the potential donor to discuss any reluctance to donate privately, and apart from their family. They will be reassured that if at any time they do not wish to donate, the recipient will be told only that the donor was not acceptable and the exact reason for this will not be made available. Both the investigators and the donor advocate will perform the process of obtaining informed consent from the donor on two separate occasions not less than one week apart. There will be a thorough discussion of the risks and benefits of the surgery and data will be provided from the short- and long-term follow-up of pediatric donors. These discussions will be with both a transplant hepatologist and surgeon. Once these discussions have taken place, the donor will be given an informed consent form to sign. In seven to ten days, the donor will be approached again regarding liver donation and another consent form will be presented to the donor. After the second consent is signed, it is felt that the donor has met all the physical and emotional requirements for liver donation. If, at the second meeting, the donor requests more time to make an informed consent, this shall be granted. Written consent will also be obtained from the recipient at this time.
Donor Surgical Technique:
- The donor liver will be partitioned to provide a full right lobe.
- Intraoperative examination of the liver parenchyma for unsuspected lesions, steatosis will be performed. Intraoperative cholangiography will also be performed to assess the appropriate site of parenchymal transection.
- Once suitability is confirmed. The appropriate recipient will be brought into the operating room and the hepatectomy begun.
- During the hepatectomy both the right and left hepatic arteries will be left as long as possible. The portal veins shall be dissected to a level above the confluence of the L \& R portal branches.
- The use of either a right or left lobe will mandate a piggyback technique to be used, as no vena cava will be procured.
- Arterial anastomosis will be performed with either high-powered loupes or with an operating microscope.
Clearly, information such as actual GWRLW and actual GRBWR will only be available retrospectively (after the donor hepatectomy). The decision to use the donor organ for a living donor liver transplant will be based upon the calculated GWRLW and GRBWR preoperatively.
- Conditions
- Liver Disease, Liver Neoplasms
- Being tested
- donor right hepatic lobectomy
- Keywords
- Liver Transplantation, Living Donors, End Stage Liver Disease
- Medical subject headings
- Liver Diseases, Liver Neoplasms, End Stage Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donor right hepatic lobectomyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome for donors in this study will be the determination of whether right hepatic lobectomy is a safe procedure for the donor as measured by survival, the incidence of surgical complications, liver function and regeneration studies.
Measured: post transplant
The primary outcome for recipients will be the assessment of patient and graft survival. Comparison to results of contemporaneous, non-randomized cadaver donor transplants will be made.
Measured: post transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2005 (estimated)
- Study startApr 2000
- Primary completionSep 2006
- Study completionSep 2006
Why it stopped: Poor accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J. Michael Millis, MD, Principal investigator, The University of Chicago Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00152607
- Sponsor's protocol ID
- 10050
- Status last verified
- Sep 2013
- First submitted
- 8 Sep 2005
- Last updated
- 27 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Orthotopic Liver Transplantation Using a Living Donor Into An Adult Recipient
- ClinicalTrials.gov ID
- NCT00152607
- Acronym / sponsor ID
- 10050
- Conditions
- Liver Disease, Liver Neoplasms
- Keywords
- Liver Transplantation, Living Donors, End Stage Liver Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor accrual
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Apr 2000
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 9 Sep 2005 (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.
The purpose of this study is to:
determine the safety of donor right hepatic lobectomy as a procedure to provide a liver graft for living donor liver transplantation.
study the regeneration of liver tissue by volumetric testing for both donor and recipient.
assess if graft and patient survival with living donor transplantation is comparable to that of cadaveric donor transplantation.
Detailed description
Preoperative Evaluation of Recipients:
Recipients who consent for living donor liver transplantation will have the following measurements performed in addition to those normally performed in their pretransplant workup.
- Ideal, dry and current body weights.
- An estimation of the recipient's actual liver volume will be determined by linear CT scanning. Continuous axial-10 mm-thick slices will be obtained following IV contrast. The area of the liver will be electronically outlined on the CT console and then multiplied by the slice thickness. This measurement will be used to assess the accuracy of CT in predicting liver weight and volume by comparing it to the actual volume displacement and weight following hepatectomy.
- The expected ideal volume of the recipient liver will be calculated from the patient's body weight. Standard liver volume (ml) = 706.2 x (body surface area [m2] + 2.4. Body surface area is calculated from the following formula: BSA = Square root of (Height [inches] x Weight [lbs.]/3131). Example: A recipient who is 5'4" and weighs 121 lbs. has a body surface area of 1.58m2. Thus the estimated ideal liver volume for this recipient is 1120 cc. In order to provide adequate hepatic parenchyma for function they would require 35%-40% of this volume = 392 - 447 cc of liver tissue.
Donor Evaluation:
- Actual and ideal body weight.
- History and physical exam.
- Psychosocial evaluation of the donor will be performed by a social worker for the kidney transplant program. Since he is not affiliated with the liver program, he will be able to objectively assess the potential donor's psychosocial condition. He will continue to see the patient (donor) after the operation while hospitalized and as an outpatient once and then on a prn basis.
- Evaluations by a donor advocate physician who is not part of the transplant department. The potential donor will be interviewed alone by the physician and allowed to express reservations concerning the procedure in private. The donor advocate physician will review the donor workup in detail to ensure its appropriateness. Should the donor advocate physician indicate that the donor is unsuitable, the donor will be excluded from further evaluation.
- Donor must be in usual state of health, with normal liver function and no major pre-existing medical conditions.
- Laboratory testing to rule out concomitant disease that would exclude donation would include the following: Blood type and HLA CBC with differential, platelet count Chem 17, SGPT, GGTP, Calcium, Magnesium PT, PTT Pregnancy test for premenopausal women Hepatitis B surface antibody, hepatitis B surface antigen, hepatitis C HIV serology CXR, EKG Cardiac stress test and pulmonary function tests if indicated
- An estimation of the recipient's right and left lobe size will be determined by linear CT scanning. Continuous axial-10mm-thick slices will be obtained following IV contrast. The area of the liver will be electronically outlined on the CT console and then multiplied by the slice thickness. This measurement will be used to assess the accuracy of CT in predicting liver weight and volume by comparing it to the actual volume displacement and weight following hepatectomy in the donor.
- Hepatic arteriogram to evaluate the arterial anatomy of the liver.
- Liver biopsy.
- Informed consent.
The donor consent is a crucial ethical issue. The donor must be exceptionally well informed concerning the risks of partial hepatectomy. A more difficult element of informed consent, however, is that the donor must make a voluntary choice without coercion. In order to avoid coercion, living donor liver transplants will not be performed in emergency situations. By excluding emergent cases, time to fully consider both the experimental option of living donor transplantation and the standard option of cadaveric donor transplantation will be afforded.
The potential donor will be medically evaluated by an independent (non-study related) physician prior to any consideration of hepatectomy. Karen Kim, M.D., and Sunanda Kane, M.D., both in the section of gastroenterology, will be the donor physician/advocates. We feel that their knowledge of gastroenterology is necessary given the nature of the contemplated surgery, hepatic lobectomy. However, neither of them have affiliations to the liver transplant team, either clinical or research. These physicians will not know the potential recipient's status, will be the final arbiter of the donor's suitability, and will serve as the donor's advocate throughout the transplantation process.
The donor and recipient will both undergo psychosocial evaluation prior to the procedure. This will be to determine psychological suitability for living donor transplantation and to explore personal and family support resources. These interviews will allow both the potential donor and recipient an opportunity to express reluctance to proceed with an individual not directly involved with the transplant procedure. Perhaps the most coercive element for a potential living donor is the perception that it is the expectation of the recipient's family that one should volunteer to donate. This element of coercion can be minimized by allowing the potential donor to discuss any reluctance to donate privately, and apart from their family. They will be reassured that if at any time they do not wish to donate, the recipient will be told only that the donor was not acceptable and the exact reason for this will not be made available. Both the investigators and the donor advocate will perform the process of obtaining informed consent from the donor on two separate occasions not less than one week apart. There will be a thorough discussion of the risks and benefits of the surgery and data will be provided from the short- and long-term follow-up of pediatric donors. These discussions will be with both a transplant hepatologist and surgeon. Once these discussions have taken place, the donor will be given an informed consent form to sign. In seven to ten days, the donor will be approached again regarding liver donation and another consent form will be presented to the donor. After the second consent is signed, it is felt that the donor has met all the physical and emotional requirements for liver donation. If, at the second meeting, the donor requests more time to make an informed consent, this shall be granted. Written consent will also be obtained from the recipient at this time.
Donor Surgical Technique:
- The donor liver will be partitioned to provide a full right lobe.
- Intraoperative examination of the liver parenchyma for unsuspected lesions, steatosis will be performed. Intraoperative cholangiography will also be performed to assess the appropriate site of parenchymal transection.
- Once suitability is confirmed. The appropriate recipient will be brought into the operating room and the hepatectomy begun.
- During the hepatectomy both the right and left hepatic arteries will be left as long as possible. The portal veins shall be dissected to a level above the confluence of the L \& R portal branches.
- The use of either a right or left lobe will mandate a piggyback technique to be used, as no vena cava will be procured.
- Arterial anastomosis will be performed with either high-powered loupes or with an operating microscope.
Clearly, information such as actual GWRLW and actual GRBWR will only be available retrospectively (after the donor hepatectomy). The decision to use the donor organ for a living donor liver transplant will be based upon the calculated GWRLW and GRBWR preoperatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-55
- No current or prior history of heart, lung or other medical problems.
- No history of liver disease.
- No history of malignancy, except limited basal cell carcinoma.
- ABO / HLA compatibility with the recipient.
Key exclusion criteria (7 listed)
- Pregnant or nursing females.
- Patients with significant concomitant infections.
- Patients who require multiple organ transplants.
- Significant pulmonary disease. If pulmonary disease is clinically suspected, diagnostic studies will be performed to exclude the presence of pulmonary hypertension (PA systolic pressure >40 mm Hg) or arterial saturation (Po2<60 mmHg, breathing room air).
- Patients at a higher than average perioperative risk secondary to severe decompensated liver disease or previous surgery (i.e., re-transplantation) or infections.
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 |
|---|---|---|
| donor right hepatic lobectomy | Procedure or surgery | – |
Primary outcome
The primary outcome for donors in this study will be the determination of whether right hepatic lobectomy is a safe procedure for the donor as measured by survival, the incidence of surgical complications, liver function and regeneration studies.
Time frame: post transplant
The primary outcome for recipients will be the assessment of patient and graft survival. Comparison to results of contemporaneous, non-randomized cadaver donor transplants will be made.
Time frame: post transplant
Results and safety
The study was stopped early (reason given: Poor accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2013.
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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.
J. Michael Millis, MD principal investigator
The University of Chicago Hospitals
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 donor right hepatic lobectomy in people with Liver Disease and Liver Neoplasms, run by University of Chicago 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 9 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: stopped early, as of the sponsor's last update on 27 Sep 2013. 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: Poor accrual). 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?
The primary outcome for donors in this study will be the determination of whether right hepatic lobectomy is a safe procedure for the donor as measured by survival, the incidence of surgical complications, liver function and regeneration studies. (time frame: post transplant). 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 27 Sep 2013.