Evaluation of Combined Endoscopic Ultrasound Ductal Evaluation Before & After Secretin Stimulation in One EUS Session for the Diagnosis of Exocrine Pancreas Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 2
- 主要终点
- Combined Endoscopic Ultrasound Morphologic Evaluation, Endoscopic Pancreatic Function Testing (ePFT), and Dynamic EUS Ductal Evaluation (sEUS)
研究概览
简要总结
The purpose of this study is, to develop a standard of care protocol using the combination of EUS, ePFT, and sEUS during one endoscopic session (instead of the three separate endoscopic sessions). The desired outcome is to diagnose CP and to establish an acceptable protocol for performing this combined technique. It is expected that combining these procedures will eliminate redundant portions of the procedures, reduce repeat visits to the hospital, reduce total recovery time for the patient, and will decrease the associated costs of separate procedures. Chronic pancreatitis (CP) is an irreversible, disease in which the pancreas becomes fibrotic ( thickened and scarred). Symptoms almost always include pain, and as the pancreas becomes progressively more fibrosed (thickened), pancreatic hormonal function is compromised with diarrhea and weight loss. However, while most physicians can readily diagnose patients with severe CP, early CP or "minimal-change" CP is difficult to detect, often due to the lack of radiologic findings, laboratory tests and classic symptoms. As a result, clinicians are searching for diagnostic tools which will allow for earlier, accurate detection of this disease, with the hope that appropriate therapy can be initiated before extensive thickening and scarring of the pancreas occurs.
Diagnostic tools to evaluate the pancreas include Endoscopic Ultrasound (EUS), hormone-stimulated endoscopic pancreatic function tests (ePFT) and Secretin stimulated Endoscopic Pancreas Function Test (sPFT) using pancreatic fluid (containing bicarbonate) obtained from the duodenum (the part of the intestine where the stomach opens into the small bowel). EUS is increasingly being used as a diagnostic and treatment tool in pancreatic disease. Currently, hormone-stimulated ePFT is considered the best way to diagnose chronic pancreatitis (long-lasting inflammation and scarring of the pancreas), and removes the need for biopsy or surgery. It is also sensitive in detecting mild disease.
These procedures are standard of care (the normal care you would receive) for the evaluation of CP. The purpose of this study, is to develop a standard of care protocol using the combination of EUS, ePFT, and sEUS during one endoscopic session, instead of three separate endoscopic procedures.
详细描述
Combined EUS, e-PFT and sEUS Testing:
The endoscopic procedures for this study will be performed by a single endoscopist at each center. It is expected that the combined EUS, ePFT and sEUS will be completed in less than 75 minutes. Patient sedation will be accomplished via standard conscious (Midazolam, Fentanyl and/or Meperidine) sedation or monitored (Propofol) sedation as per the study investigator and America Society of Gastrointestinal Endoscopy (ASGE) and American Society of Anesthesiology (ASA) guidelines.
A mechanical-radial EUS echoendoscope with color Doppler assessment capability will be passed via standard technique and the pancreas examined from the gastric and duodenal stations. Representative EUS images will be recorded on digital videotape/digital snapshot from the head, body and tail per the CRF. See Appendix B. These images will then become part of the patient's electronic medical record. The echoendoscope will be used to measure specific parenchymal (hyperechoic foci with shadowing, hyperechoic strands with shadowing, lobular contour, cysts, calculi) and ductal (main ductal diameter, irregularity, hyperechoic margins, stones and the presence of visible side branches) abnormalities. It is expected that this evaluation will be completed in approximately 10 minutes. Prior to secretin administration (baseline MPD diameters), the pancreatic duct diameter will be measured in the head, body, and tail using endosonographic calipers. The investigator will provide an initial assessment of the presence or absence of chronic pancreatitis prior to secretin administration.
Next, the echoendoscope will be used to aspirate the gastric and duodenal lumens dry. The gastric and duodenal samples will then be discarded.
Once the gastric and duodenal lumens have been aspirated dry, patients will be given a test dose of human secretin of 0.2 mcg (0.1mL) through an indwelling catheter in a peripheral vein to assess for a possible allergic response. Patients will be monitored at all times for evaluation of hemodynamic instability. If after one minute there is no evidence of an allergic reaction, the remaining full dose of secretin 0.2 mcg/kg IV will be given over one minute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, between the ages of 18-80 years old.
- •Clinical suspicion of pancreatic exocrine disease.
- •If female and not more than 1 year post-menopausal or surgically sterile, must use medically acceptable form of contraception or abstain from sexual activity during the study. Acceptable methods of birth control are: intrauterine device, implantable progesterone device, progesterone intramuscular injection, oral contraceptive (started at least one month prior to Screening Visit 1 and continuing for the duration of the trial), contraceptive patch, condoms with spermicide or abstinence.
- •EUS and ePFT planned for structural and functional evaluation of the exocrine pancreas.
- •Ability to undergo conscious sedation or monitored anesthesia.
- •Willing and able to sign written informed consent.
排除标准
- •Symptoms of acute pancreatitis within 30 days of the combined function test.
- •Severe cardiac disease (stable or unstable angina, congestive heart failure, uncontrolled arrhythmias, implantable defibrillator, severe valvular disease, etc).
- •Severe pulmonary disease (COPD, severe asthma, interstitial lung disease, etc).
- •Severe renal disease (history of acute or chronic renal failure and/or dialysis dependent and/or baseline creatinine >2.0 mg/dL).
- •Pregnant or nursing.
- •Ongoing illicit drug use or abuse.
- •Ongoing moderate or severe alcohol use defined by greater than 30 grams alcohol/day.
- •Acute pancreatitis as defined by the Atlanta Classification definition (see Appendix D) within the previous two months.
- •Prior pancreatic surgery.
- •Presence of a condition which may interfere with exocrine pancreatic functioning including celiac disease, type I diabetes mellitus, previous gastrectomy, cystic fibrosis or severe malnutrition (BMI <18).
- •Exhibiting signs or symptoms of an episode of acute pancreatitis.
- •Known allergy to secretin.
- •Recent (within 30 days) use of medication that can potentially cause pancreatitis, such as metronidazole, tetracycline, sulfonamides.
- •Use of any anticholinergic medication within 48 hours of enrollment.
- •Any medical condition which in the judgment of the Investigator renders participation in this study medically inadvisable.
- •Participation in an investigational clinical study for a drug or medical device within 30 days prior to Screening Visit
- •Suspected or proven Sphincter of Oddi Dysfunction.
- •Previous pancreatic endoscopic or surgical sphincterotomy
研究组 & 干预措施
Combined EUS, e-PFT and sEUS Testing
Establish the advantage of combined EUS, ePFT & sEUS testing to provide a more definitive diagnostic assessment, rather than each test alone.
Establish the advantage of reduced time and cost of combining EUS and ePFT, rather than when done separately.
干预措施: Combined EUS, e-PFT and sEUS Testing (Procedure)
结局指标
主要结局
Combined Endoscopic Ultrasound Morphologic Evaluation, Endoscopic Pancreatic Function Testing (ePFT), and Dynamic EUS Ductal Evaluation (sEUS)
时间窗: 48 months (anticipated)
Combined Endoscopic Ultrasound Morphologic Evaluation, Endoscopic Pancreatic Function Testing, and Dynamic EUS Ductal Evaluation before and after Human Secretin Stimulation in one Endoscopic Session for the Diagnosis of Exocrine Pancreas Disease
次要结局
- Advantage of combining EUS and ePFT to provide a more definitive diagnostic assessment, rather than each test alone.(48 months (anticipated).)
研究者
John DeWitt
Director of Endosocpic Ultrasound
Indiana University