Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Renal Insufficiency

Antineoplastic Agents

All Drugs and Chemicals

Hematinics

Paclitaxel

Carboplatin

Albumin-Bound Paclitaxel

Liver Extracts

Poly(ADP-ribose) Polymerase Inhibitors

Veliparib

Tubulin Modulators

Antimitotic Agents

Enzyme Inhibitors

ABT-888

Background:

- Paclitaxel and carboplatin are two standard drugs that stop cancer cells from reproducing. ABT-888 is an experimental cancer drug that may prevent cancer cells from "fixing" the damage done by chemotherapy drugs. This may make the chemotherapy work better. More tests are needed to determine the safety and effectiveness of ABT-888 plus chemotherapy. Researchers also want to find the best dose of ABT-888 for people who have kidney or liver problems in addition to cancer.

Objectives:

- To test the safety and effectiveness of ABT-888 plus carboplatin and paclitaxel in people who have both cancer and kidney or liver problems.

Eligibility:

* Individuals at least 18 years of age who have solid tumors that have not responded to standard treatment, and who also have kidney or liver problems.
* A small group of people with solid tumors and normal kidney and liver function may also receive treatment for study comparison purposes.

Design:

* Participants will be screened with a medical history and physical exam. They will have blood and urine tests, tumor samples, tests of liver and kidney function, and imaging studies. Participants will also provide a hair sample at the start of the study.
* Participants will take one dose of ABT-888 1 week before starting chemotherapy. The two chemotherapy drugs will be given on day 3 of a 21-day cycle. Participants will take ABT-888 daily for the first 7 days of each cycle.
* They will keep a diary to record medication doses and any side effects. They will also have frequent blood tests and imaging studies. Participants will provide more hair samples on day 3 of cycle 1 before and after having paclitaxel.
* Participants will continue treatment for up to 18 weeks as long as the cancer stops growing or shrinks and there are no serious side effects. Participants may have the option to continue treatment after the study is done.

Background:

The poly (ADP-ribose) polymerase (PARP) family of enzymes is critical for maintaining genomic stability by regulating a variety of DNA repair mechanisms. The carboplatin/paclitaxel combination has demonstrated a wide spectrum of clinical antitumor activity, making it an ideal platform for evaluation with novel agents, such as the PARP inhibitor ABT-888.

Objectives:

To determine the pharmacokinetics and pharmacodynamics of ABT-888 in patients with varying degrees of renal or hepatic dysfunction.

To determine the maximum tolerated dose (MTD) of ABT-888 in combination with carboplatin and paclitaxel for patients with varying degrees of liver or kidney dysfunction.

To provide dosing recommendations for ABT-888 in combination with carboplatin and paclitaxel based on degree of hepatic and renal impairment.

To define the dose-limiting toxicity and other toxicities associated with the use of this combination in patients with varying degrees of renal or hepatic dysfunction.

To evaluate the pharmacokinetic parameters of ABT-888, carboplatin and paclitaxel when administered as a combination in patients with varying degrees of renal or hepatic dysfunction.

To evaluate the pharmacodynamic measurement of PAR and platinum adducts in peripheral blood mononuclear cells (PBMC) and tumor cells associated with the use of this combination

in patients with varying degrees of renal or hepatic dysfunction.

Eligibility:

Patients must have histologically confirmed malignancy that is metastatic or unresectable, for which standard curative or palliative measures do not exist or are no longer effective, and for which there is expectation of response to the combination of carboplatin/paclitaxel (e.g., lung, ovarian, breast, and melanoma).

Patients must have adequate bone marrow function.

Patients with normal organ function, patients with all degrees of renal dysfunction, and patients with mild to severe hepatic dysfunction are allowed.

Study Design:

ABT-888 (80 mg) will be given orally on day -6 ( 1 day) of cycle 1 in all cohorts. ABT-888 in varying doses will then be given on days 1-7 of each cycle, with the dose depending on each patient's degree of renal or hepatic dysfunction.

Fixed doses of chemotherapy will be given intravenously on day 3 of each cycle. For patients with renal dysfunction, carboplatin will be given at AUC of 6 and paclitaxel at 175 mg/m2. For patients with hepatic dysfunction, carboplatin will be given at AUC of 6 and paclitaxel at doses adjusted to each patient's degree of hepatic dysfunction.

The dose of ABT-888 will be escalated to determine the MTD of the combination.

ABT-888, Carboplatin, and Paclitaxel for Cancer With Liver or Kidney Problems

An Early Phase 1 Study of ABT-888 in Combination With Carboplatin and Paclitaxel in Patients With Hepatic or Renal Dysfunction and Solid Tumors

National Cancer Institute (NCI)

Symptoms and General Pathology

Digestive System Diseases

Neoplasms

Infections

Rare Diseases

Inflammation

Liver Diseases

Hepatitis

Fibrosis

Liver Neoplasms

Hepatic Insufficiency

Liver Failure

Liver Failure, Acute

Liver Cirrhosis

Hepatitis A

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Acute Graft Versus Host Disease

Patient Registry aiming to provide regional evidence documenting the clinical merit of EUS (Endoscopic_ Ultrasound) guided liver biopsy, per local standard of practice, in patients with suspected liver disease indicated for an endoscopic intervention and a liver biopsy.

The finding of this patient Registry may lead to recommendations towards optimizing liver biopsy procedures. If the study demonstrates the optimization of the number of interventions needed to reach diagnostic and therapeutic goals in the setting of suspected liver disease thanks to the utilization of Acquire compared to other liver biopsy procedures, this data can be used as part of economic messaging of the BSC Acquire Fine Needle Biopsy.

This Registry will document all relevant diagnostic and therapeutic radiologic - trans jugular or percutaneous - and endoscopic/endosonographic interventions which enrolled patients undergo when they are suspected to have liver disease and are indicated for an endoscopic procedure and liver biopsy. The study will help illustrate that an EUS guided approach for liver biopsy in patients with suspected liver disease that is indicated for:

Upper endoscopy and Liver biopsy will benefit both the patients and the hospitals from completing both procedures in one setting.

Where possible, the proposed Registry will also allow for the dynamic assessment of the severity of liver disease and for monitoring of changes to therapy for liver fibrosis and/ or portal hypertension. It is anticipated that the ability to monitor changes in liver status over time will become increasingly important as new therapies emerge in the field.

Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry

Registry of Endoscopic Ultrasound Guided Assessment of the Liver (REGAL Study)

Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 30 days after the first upper Endoscopy procedure on study \[ Phase 1\]

Number of endoscopic, endosonographic, and radiologic interventions undergone to reach a diagnostic liver biopsy in the setting of suspected liver disease from three months prior, to 12 months after the first upper Endoscopy procedure on study \[ Phase 2\]

Number of serious adverse events related to all livery biopsy study procedures (Phase 1 and Phase 2)

number of participants with abnormal levels of liver function tests

number of participants with abnormal non-invasive liver imaging

Number of diagnostic liver biopsies in radiologically guided compared to the EUS-guided liver.

biopsy (Phase 1 and Phase 2)

Boston Scientific Corporation

Sheikh Shakhbout Medical City

Irinotecan

Topoisomerase I Inhibitors

Drugs used in chemotherapy us different ways to stop tumor cells from dividing so they stop growing or die. Irinotecan may be effective in treating patients with refractory solid tumors and liver dysfunction.

Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction

Pfizer

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Anticoagulants

Micronutrients

Bone Density Conservation Agents

Edetic Acid

Pentetic Acid

Antidotes

Protective Agents

Chelating Agents

Iron

Iron Chelating Agents

Calcium

Calcium, Dietary

Patients who will undergo resection of at least two hepatic segments for HCC or radiofrequency ablation (RFA) for HCC and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI

Potential liver donors with normal hepatic function and and underwent gadoxetic acid (Gd-EOB-DTPA)-enhanced MRI

1. Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver.
2. Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion.

Gd-EOB-DTPA

1. Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test.
2. Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion.

1. Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver.
2. Multiphasic MRI including dynamic hepatocyte specific phase will be performed for evaluation of hepatic extraction fraction, with 25 phase dynamic MRI obtained until 30 minutes after contrast injection.

1. Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test.
2. Multiphasic MRI including dynamic hepatocyte specific phase will be performed for evaluation of hepatic extraction fraction, with 25 phase dynamic MRI obtained until 30 minutes after contrast injection.

Jeong Min Lee, MD, PhD

The purpose of this study is to determine whether the global and segmental hepatic uptake and excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard liver function test results in the patients with Hepatocellular Carcinoma (HCC) before major hepatic resection or radiofrequency ablation (RFA).

1. Preoperative/RFA assessment of remnant liver function is important for avoiding posthepatectomy liver failure. However, the function of the future remnant is decreased in patients with chronic liver disease or cirrhosis, compared to that of healthy patients with an equal volume. Therefore, volume-based estimation of hepatic reserve function is inadequate for patients with hepatic dysfunction.
2. Standard clinical liver function tests, such as ICG clearance rate or Child-Pugh score, provides measurements of the global hepatic function, but cannot evaluate the functional distribution in the liver. Gd-EOB-DTPA (Gadoxetic acid, Primovist®, Bayer Schering) enhanced MRI has been recently demonstrated to have the potential to be an imaging-based liver function test, with the possibility to detect functional differences on a regional or even segmental level.
3. Gd-EOB-DTPA-enhanced liver MRI may be able to assess not only global but also segmental liver function in patients with hepatocellular carcinoma (HCC) who have a relatively high risk for developing liver failure after surgical resection due to coexistent hepatic damage by chronic viral hepatitis and/or cirrhosis preoperatively.

The purpose of this study is to determine whether the global and segmental hepatic uptake and excretion of Gd-EOB-DTPA on Gd-EOB-DTPA-enhanced liver MRI correlates with standard liver function test results in the patients with HCC before major hepatic resection/RFA.

Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma

Pre-Surgical Treatment or Radio Frequency Ablation (RFA) Evaluation of Future Remnant Liver Function Using Gd-EOB-DTPA Enhanced MRI in Patients Undergoing Hepatic Resection /RFA for Hepatocellular Carcinoma

Predicted RLF (HEF mL) = the sum of the individual HEF of each voxel in future remnant segment

1. Functional parameters derived from Gd-EOB-DTPA enhanced MRI include hepatic extraction fraction \[HEF\], input-relative blood flow \[irBF\], hepatocellular uptake index \[HUI\], liver to spleen ratio (LSR).
2. Volumetric parameters include global liver volume and remnant liver volume.
3. Clinical liver function tests include ICG R15, MELD score and Child-Pugh score.
4. ICG R15 \[Indocyanine green retention at 15 minutes, %\] test will be performed within 3 days of preoperative MRI and 3 days after surgical resection.

1. Clinical parameters refer to the following.

   * Frequency of POD#5 days 50-50 criteria
   * Evaluation of operation related complication
   * Incidence of hepatic failure or death
2. Functional and volumetric MRI parameters of patients with postoperative complication and morbidity will be evaluated.
3. Correlation of MRI parameters with laboratory liver function tests.

1. Correlation of functional parameters derived from Gd-EOB-DTPA enhanced MRI with ICG R15
2. Correlation of functional and volumetric parameters derived from Gd-EOB-DTPA enhanced MRI
3. Correlation of volumetric parameters derived from Gd-EOB-DTPA enhanced MRI and ICG15
4. Comparison of functional MRI parameters between potential liver donors and patients undergoing hepatic resection for HCC.

Bayer

Seoul St. Mary's Hospital

Asan Medical Center

Chonnam National University Hospital

Seoul National University Hospital

Associate Professor

In this group , patients will undergo biliary reconstruction using surgical loupe

In this group , patients will undergo biliary reconstruction using microscope

Biliary reconstruction will be performed using surgical loupe

Surgical Loupes

Biliary reconstruction will be performed using microscope

Microscope

Comparison of biliary complications in right lobe living donor liver transplantation patients undergoing biliary reconstructions using microscope versus surgical loupes .

Liver transplantation (LT) is the most effective treatment modality in patients with end-stage liver disease and it is also established as a viable treatment option in the field of oncology. Living donor liver transplantation (LDLT) using the right lobe (RL) is a major achievement despite its technical challenges, which has created a significant increase in graft supply. While a secure bile duct anastomosis is one of the basic principles of a successful liver transplant procedure, biliary reconstruction remains the Achilles' heel of LDLT because of the high incidence of posttransplant biliary complications associated with significant recipient morbidity and mortality. Some of these complications are related to technical difficulties due to multiple small biliary orifices, particularly in right lobe grafts. In our center, we have been using microsurgical reconstruction technique for duct-to-duct biliary anastomosis in such grafts. The routine use of this technique has been shown to significantly decrease biliary complications in single-center retrospective studies. However, prospective controlled studies comparing microsurgical and standard biliary reconstruction techniques are lacking. In this study, our objective is to compare posttransplant complications of the two techniques of biliary reconstruction in RL LDLT.

40 patients will be included in the study. They will be randomly allocated in the equal groups.İn group 1 biliary anastomosis will be performed using surgical loupes and İn group 2 biliary anastomosis will be performed using microscope. The patients will be followed for one year after the transplant to compare biliary complications.

The patients will be randomly allocated in the equal groups.İn group 1 biliary anastomosis will be performed using surgical loupes and İn group 2 biliary anastomosis will be performed using microscope.

Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation

Prospective Randomized Single-center Trial Comparing Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation

Incidence of biliary complications after living donor liver transplantation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ABT-888, Carboplatin, and Paclitaxel for Cancer With Liver or Kidney Problems	NCT01419548	Neoplasms	ABT-888 Carboplatin Paclitaxel	18 Years - 110 Years	National Institutes of Health Clinical Center (CC)
Endoscopic Ultrasound Guided Liver Biopsy and Portal Pressure Registry	NCT05817994	Liver Diseases Liver Neoplasms Liver Dysfuncti... Liver Failure, ... Liver Fibrosis Liver Inflammat...		-	Sheikh Shakhbout Medical City
Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction	NCT00037804	Unspecified Adu... Chemotherapy Liver Dysfuncti... Neoplasms, Soli...	Irinotecan	18 Years -	Pfizer
ABT-888, Carboplatin, and Paclitaxel for Cancer With Liver or Kidney Problems	NCT01419548	Neoplasms	ABT-888 Carboplatin Paclitaxel	18 Years - 110 Years	National Institutes of Health Clinical Center (CC)
Evaluation of Remnant Liver Function Using Primovist-enhanced MRI Before Resection/Ablation of Hepatocellular Carcinoma	NCT01490203	Carcinoma, Hepa... Liver Dysfuncti...	Gd-EOB-DTPA Gd-EOB-DTPA MRI MRI	18 Years -	Seoul National University Hospital
Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction	NCT00037804	Unspecified Adu... Chemotherapy Liver Dysfuncti... Neoplasms, Soli...	Irinotecan	18 Years -	Pfizer
Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation	NCT04618692	Liver Failure Liver Diseases Liver Cancer Liver Neoplasms Liver Dysfuncti...	Surgical Loupes Microscope	18 Years - 75 Years	Istanbul Medipol University Hospital
Biliary Anastomosis Using Surgical Loupe Versus Microscope in Living Donor Liver Transplantation	NCT04618692	Liver Failure Liver Diseases Liver Cancer Liver Neoplasms Liver Dysfuncti...	Surgical Loupes Microscope	18 Years - 75 Years	Istanbul Medipol University Hospital
Irinotecan in Treating Patients With Refractory Solid Tumors and Liver Dysfunction	NCT00037804	Unspecified Adu... Chemotherapy Liver Dysfuncti... Neoplasms, Soli...	Irinotecan	18 Years -	Pfizer

Spots Global Cancer Trial Database for liver dysfunction