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Hepatic Effects of Gastric Bypass Surgery

18 giugno 2020 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

106

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Stati Uniti
    • Ohio
      • Cleveland, Ohio, Stati Uniti, 44159
        • Cleveland Clinic

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: 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
Altro: 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
Altri nomi:
  • biopsia
  • ago
  • liver

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Aspartate Transaminase (AST) Change
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Diagnostic Accuracy-AST
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

The Cleveland Clinic

Investigatori

  • Investigatore principale: Brian M. Parker, MD, The Cleveland Clinic

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2008

Completamento primario (Effettivo)

1 febbraio 2014

Completamento dello studio (Effettivo)

1 settembre 2014

Date di iscrizione allo studio

Primo inviato

18 giugno 2008

Primo inviato che soddisfa i criteri di controllo qualità

18 giugno 2008

Primo Inserito (Stima)

19 giugno 2008

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

19 giugno 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

18 giugno 2020

Ultimo verificato

1 giugno 2020

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 07-877

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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