Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

Hepatic Effects of Gastric Bypass Surgery

18 czerwca 2020 zaktualizowane przez: The Cleveland Clinic

Long Term Hepatic Effects of Gastric Bypass Surgery

Liver disease in the morbidly obese is thought to occur due to the long-term presence of fat deposits in the liver, resulting in inflammation and scarring of the liver over time, which reduces liver function. However, many of these patients are unaware that their liver is damaged. There is currently no consensus regarding what the long-term effects of gastric bypass surgery are on pre-existing liver disease in morbidly obese patients. This study will determine the long-term effects on the liver after this type of surgical procedure.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Szczegółowy opis

Before or on the day of surgery liver function will be determined using the DDG-2001 Analyzer. This monitor is able to detect the concentration of a dye called indocyanine green dye (ICG) when present in the blood stream. A dose of 0.5 mg/kg of ICG will be injected into an IV in the arm. Over approximately fifteen minutes the DDG-2001 Analyzer will determine how quickly the liver removes the dye ICG from the blood stream. This value represents how well the liver is functioning. Blood samples are drawn before injection of ICG to measure liver function using standard liver function tests.

This same routine for injecting ICG and obtaining blood for routine liver function tests will happen one more time, after surgery, once the subject has lost a significant amount of the original weight (60% of excess weight). This amount of weight loss typically occurs between 12 to 18 months after gastric bypass surgery. This second ICG measurement will occur during an outpatient follow-up visit to CCF.

A biopsy will be taken from the liver during surgery. A second biopsy taken after the 60% weight loss will be compared to determine the effect of this surgery on the liver.

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

106

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  1. BMI > 40.
  2. Documented failed non-surgical treatment for morbid obesity.
  3. Ability to undergo long-term follow-up after LGBS.

Exclusion Criteria:

  1. BMI < 40.
  2. Subject age < 18 years.
  3. Inability to undergo long-term follow-up after LGBS (living distance > 300 miles).
  4. Patients with known ESLD.
  5. Patients found to have evidence of ESLD during preoperative evaluation for LGBS including portal hypertension, ascites, and coagulopathy.
  6. Patients with known iodine sensitivity or allergy.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nie dotyczy
  • Model interwencyjny: Zadanie dla jednej grupy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: liver function
Subjects undergoing laparoscopic gastric surgery will be evaluated for liver function by comparing liver tissue biopsied during surgery with tissue biopsied after 60% weight loss
Inny: liver biopsy
Subjects undergoing laparoscopic gastric surgery will be evaluated for liver function by comparing liver tissue biopsied during surgery with tissue biopsied after 60% weight loss
Inne nazwy:
  • biopsja
  • igła
  • liver

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Aspartate Transaminase (AST) Change
Ramy czasowe: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
Alanine Transaminase (ALT) Change
Ramy czasowe: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
Alkaline Phosphate (ALK)
Ramy czasowe: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
Total Bilirubin
Ramy czasowe: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure
Albumin
Ramy czasowe: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
To assess the change in liver function from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure versus before the procedure)
from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
Prothrombin Time (PT)
Ramy czasowe: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
To assess the change in liver function from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
Partial Thromboplastin Time (PTT)
Ramy czasowe: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
To measure the change of PTT from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
Indocyanine Green (ICG) K Value
Ramy czasowe: from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
To assess the liver function change from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure). ICG-k value is the slope of the decay curve of the serum ICG clearance graph, which is used to assess the liver function as it represents the rate of disappearance of ICG from blood as the liver exclusively distracts it. The lower k value means a lower rate of ICG clearance, indicating a worse liver function.
from before surgery to the time when they lost 60% of their preoperative excess weight or weight loss had plateaued after this procedure (after the procedure minus versus before the procedure)
Number of Subjects of Nonalcoholic Steatohepatitis (NAS Steatosis)
Ramy czasowe: when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
To compare the distribution of NAS steatosis stage from before surgery to when patients lost 60% of their preoperative excess weight or weight loss had plateaued. The NAFLD activity score (NAS) from the NASH clinical Clinic Research Network is the unweighted sum of scores for steatosis, lobular inflammation, and ballooning hepatocyte degeneration, and ranges from zero to eight points. The histological reporting for grading steatosis was based on a scale of 0 to 3, with 0 being no steatosis (<5%), 1 being mild steatosis (involving 5-33% of the biopsy specimen), 2 being moderate steatosis (involving 34-66% of the specimen), and 3 being severe (involving >66%).
when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
Number of Subjects of Nonalcoholic Steatohepatitis Lobular Inflammation
Ramy czasowe: when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
Lobular inflammation was similarly scored by number of foci per 200× magnification field (0 no foci: 1 < 2 foci: 2, 2-4 foci; 3, >4 foci) on biopsy specimen under microscope. This outcome was compared on its distribution before the surgery and once patients lost 60% of their preoperative excess weight or weight loss had plateaued.
when patients lost 60% of their preoperative excess weight or weight loss had plateaued.
Fibrosis
Ramy czasowe: after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued
Fibrosis was measured from before surgery to after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued through biopsies
after surgery once they lost 60% of their preoperative excess weight or weight loss had plateaued
Nonalcoholic Steatohepatitis (NAS) Hepatocyte Balloon
Ramy czasowe: once patients lost 60% of their preoperative excess weight or weight loss had plateaued after surgery
Ballooning hepatocyte degeneration was scored as 0 (absent), 1 (few, difficult to identify), 2 (many, easily identified). This was to assess the change in the distribution of NAS hepatocyte ballon between before the surgery and once patients lost 60% of their preoperative excess weight or weight loss had plateaued
once patients lost 60% of their preoperative excess weight or weight loss had plateaued after surgery

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Diagnostic Accuracy-AST
Ramy czasowe: before RYGB surgery
AST was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
before RYGB surgery
Diagnostic Accuracy-ALT
Ramy czasowe: before RYGB surgery
ALT was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate and the y-axis is the true positive rate. The AUC of ROC represents the performance of diagnostic measures/models, the higher score means better performance in general. The range of AUC is from 0 to 1.0.
before RYGB surgery
Diagnostic Accuracy-ALK
Ramy czasowe: before RYGB surgery
ALK was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate and the y-axis is the true positive rate. The AUC of ROC represents the performance of diagnostic measures/models, the higher score means better performance in general. The range of AUC is from 0 to 1.0.
before RYGB surgery
Diagnostic Accuracy-total Bilirubin
Ramy czasowe: before RYGB surgery
The total bilirubin was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC of ROC represents the performance of diagnostic measures/models, the higher score means better performance in general. The range of AUC is from 0 to 1.0.
before RYGB surgery
Diagnostic Accuracy-PT
Ramy czasowe: before RYGB surgery
PT was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
before RYGB surgery
Diagnostic Accuracy-PTT
Ramy czasowe: before RYGB surgery
PTT (Partial Thromboplastin Time) was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
before RYGB surgery
Diagnostic Accuracy-ICG k Value
Ramy czasowe: before RYGB surgery
ICG k value was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
before RYGB surgery
Diagnostic Accuracy-albumin
Ramy czasowe: before RYGB surgery
Albumin was measured before RYGB surgery and was used to fit a univariate logistic model to predict clinically asymptomatic but significant fatty liver, including NASH and NASH plus fibrosis. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 99.4% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
before RYGB surgery
Diagnostic Accuracy-multiple Factor
Ramy czasowe: before RYGB surgery
We also built a multivariable model using all preoperative liver function tests and ICG k clearance values to predict NASH (nonalcoholic steatohepatitis) from pre-RYGB values. AUC was used to assess the prediction performance of those multiple factors. The AUC (area under the curve) of the receiver operating characteristic curve (ROC) was calculated with a 95% confidence interval. The x-axis of ROC is the false positive rate (%) and the y-axis is the true positive rate (%). The AUC value of ROC represents the performance of diagnostic measures/models, the higher value means better performance in general. The range of AUC is from 0 to 1.0 (perfect performance).
before RYGB surgery

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

The Cleveland Clinic

Śledczy

  • Główny śledczy: Brian M. Parker, MD, The Cleveland Clinic

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 czerwca 2008

Zakończenie podstawowe (Rzeczywisty)

1 lutego 2014

Ukończenie studiów (Rzeczywisty)

1 września 2014

Daty rejestracji na studia

Pierwszy przesłany

18 czerwca 2008

Pierwszy przesłany, który spełnia kryteria kontroli jakości

18 czerwca 2008

Pierwszy wysłany (Oszacować)

19 czerwca 2008

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

19 czerwca 2020

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

18 czerwca 2020

Ostatnia weryfikacja

1 czerwca 2020

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 07-877

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj