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Orthotopic Liver Transplantation Using a Living Donor

2013年9月26日 更新者:University of Chicago

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.

調査の概要

状態

終了しました

詳細な説明

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.

  1. Ideal, dry and current body weights.
  2. 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.
  3. 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:

  1. Actual and ideal body weight.
  2. History and physical exam.
  3. 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.
  4. 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.
  5. Donor must be in usual state of health, with normal liver function and no major pre-existing medical conditions.
  6. 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

  7. 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.
  8. Hepatic arteriogram to evaluate the arterial anatomy of the liver.
  9. Liver biopsy.
  10. 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:

  1. The donor liver will be partitioned to provide a full right lobe.
  2. 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.
  3. Once suitability is confirmed. The appropriate recipient will be brought into the operating room and the hepatectomy begun.
  4. 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.
  5. The use of either a right or left lobe will mandate a piggyback technique to be used, as no vena cava will be procured.
  6. 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.

研究の種類

介入

入学 (実際)

20

段階

  • フェーズ 4

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Illinois
      • Chicago、Illinois、アメリカ、60637
        • The University of Chicago Hospitals

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~55年 (大人)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  1. Age 18-55
  2. No current or prior history of heart, lung or other medical problems.
  3. No history of liver disease.
  4. No history of malignancy, except limited basal cell carcinoma.
  5. ABO / HLA compatibility with the recipient.
  6. If female and premenopausal, a negative pregnancy test.
  7. Related to recipient either by blood or marriage and having a stable, long term, emotional relationship.
  8. 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%.
  9. Satisfactory psychosocial evaluation. -

Exclusion Criteria:

Recipient Exclusion Criteria:

  1. Pregnant or nursing females.
  2. Patients with significant concomitant infections.
  3. Patients who require multiple organ transplants.
  4. 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).
  5. Patients at a higher than average perioperative risk secondary to severe decompensated liver disease or previous surgery (i.e., re-transplantation) or infections.

    -

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:非ランダム化
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

この研究は何を測定していますか?

主要な結果の測定

結果測定
時間枠
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.
時間枠:post transplant
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.
時間枠:post transplant
post transplant

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:J. Michael Millis, MD、The University of Chicago Hospitals

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2000年4月1日

一次修了 (実際)

2006年9月1日

研究の完了 (実際)

2006年9月1日

試験登録日

最初に提出

2005年9月8日

QC基準を満たした最初の提出物

2005年9月8日

最初の投稿 (見積もり)

2005年9月9日

学習記録の更新

投稿された最後の更新 (見積もり)

2013年9月27日

QC基準を満たした最後の更新が送信されました

2013年9月26日

最終確認日

2013年9月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 10050 (レジストリ識別子:DAIDS-ES)

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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