Clinical Trials

Endoscopic Retrograde Cholangiopancreatography (ERCP):

Fluoroscopy Free ERCP (Multi-center RCT)
Non-Complex Biliary Stones DSC vs ERC RCT: Prospective, Multi-center, Randomized Controlled Study Comparing Endoscopic Clearance of Non-Complex Biliary Stones Using Fluoroscopy/Radiation-Free Direct Solitary Cholangioscopy (DSC) to Standard of Care Endoscopic Retrograde Cholangiography (ERC).

Principal Investigator at UTHealth: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • 18 years or older
  • Abdominal pain consistent with choledocholithiasis (procedure possible within 72 hours of onset of symptoms and imaging suggesting choledocholithiasis, contingent on persistent abdominal pain).
  • Abnormal LFTs
  • Non-complex biliary stone disease, defined as 5 or fewer stones in the common bile or common hepatic duct with largest stone no larger than 10 mm in size. If stones not seen on imaging (US, CT) the bile duct diameter should be ≤12 mm
  • Availability of non-invasive imaging to determine the diameter of the bile duct and number and size of bile duct stones if visible on imaging.
    • If probability of stones is high per investigator assessment based on ASGE criteria, any standard of practice imaging modality (eg. abdominal US) is acceptable.
    • If the probability of stones is either intermediate or low per investigator assessment based on ASGE criteria, MRCP or EUS imaging is required to confirm presence of stones.
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

DECAP Trial: Disposable TIP Duodenoscope study (Prospective Survey)
A multi-center prospective study to evaluate performance of disposable TIP duodenoscope designed to prevent future outbreak related to contaminated duodenoscope.
Principal Investigator: Nirav Thosani, MD, MHA
Summary:
Our multi-center prospective study aims to evaluate overall performance of disposable TIP duodenoscopes and get insight from end-users regarding its performance during various steps of ERCP procedure as well as ease and feasibility of pre-procedure duodenoscope set up and post-procedure manual cleaning as well as reprocessing.

Duodenoscope Reprocessing Trial

  1. FDA 522 Postmarket Surveillance Study Sampling Procedure for Pentax Medical Duodenscope Model ED3490 TK.
  2. 522 Postmarket Surveillance Study: ED34-i10T2 Sampling and Culturing Study

Principal Investigator: Nirav Thosani, MD, MHA
Summary:
Microbiological sampling and culturing of duodenoscopes involves sampling duodenoscope channels and the distal end of the duodenoscope, followed by culturing those samples with the goal of detecting bacterial contamination that may be present on the duodenoscope after reprocessing. The main goal is to identify prevalence of microbial contamination of duodenoscope despite standardize reprocessing.

FIH EndoGI Biliary stent study (Awaiting approval)
First in Human (FIH) study for the evaluation of the safety and early performance of EndoGI Biliary Stent System device for delivery of stent(s) to the biliary tract.
Principal Investigator: Srinivas Ramireddy, MD
Co-investigator: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • Male and female subjects between the ages of 18-75 years
  • Subjects scheduled to undergo ERCP for hepatic and/or bile duct cannulation

Biliary Cannulation: Goff septotomy versus double guidewire technique (Prospective Study)
Evaluation of efficacy and safety of Goff transpancreatic septotomy vs double wire technique for achieving biliary access in technically challenging ERCPs.
Principal Investigator: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • Ages 18 and older
  • Patient has a clinical indication for ERCP
  • Willing and able to comply with the study procedures and provide written informed consent to participate in the study.

Biliary Cannulation: Outcomes of Goff Septotomy
Prospective evaluation of endoscopic transpancreatic papillary septotomy approach for difficult bile duct cannulation in patients undergoing ERCP.
Principal Investigator: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • Patients undergoing ERCP with the use of TPS approach for bile duct cannulation.
  • More than 18 years of age

Short-wire guided ERCP (Technical Outcomes)
An Assessment of Technical Outcomes of The Endoscopist Controlled Short-Wire System for Biliary ERCP.
Principal Investigator: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • Patients requiring diagnostic or therapeutic evaluation of the biliary ductal system.
  • Able to provide informed consent
  • 18 years of age or older

ERCP Radiation Exposure (Retrospective)
Comparison of Radiation Exposure to Patients During ERCPs Performed by Endoscopists Trained In Judicious Use of Fluoroscopy With Those Without Formal Training.
Principal Investigator: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • ERCP cases with use of fluoroscopy

Endoscopic Ultrasound (EUS):

Pancreatic Cyst
A Prospective Study to Identify Predictive Biological Markers in Blood and Cyst Fluid Aspirates from Patients with Pancreatic Cyst Lesions.

Principal Investigator: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • Diagnosis of Pancreatic Cystic Lesions (PCLs) or AP or CP or PC (any stage/grade) or congenital developmental anomalies of the pancreas.
  • Any combination of the diagnoses above.
  • Patients must provide written informed consent for the collection of blood specimens for research purposes.
  • Patients with PCLs must provide informed consent for collection of excess cyst fluid aspirate remaining after testing for routine standard of care
  • Patients with pancreatic Cystic Lesions (PCLs) or AP or CP or PC (any stage/grade) or congenital developmental anomalies of the pancreas undergoing surgery must provide informed consent for collection of surgical specimen.

EUS-RFA of Pancreatic Lesions: Prospective Study
Safety and Efficacy of Endoscopic Ultrasound (EUS) Guided Radiofrequency Ablation (RFA) in the Treatment of Pancreatic Lesions: A Prospective Registry.

Principal Investigator: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • Diagnosis of any Pancreatic premalignant lesion and/or Pancreatic malignancy undergoing EUS-RFA for its treatment.

Artificial intelligence for pancreatic cancer cytopathology Trial
Artificial Intelligence for Rapid on-site evaluation (AI-ROSE) for endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) biopsy of Pancreatic Solid Lesions: A prospective double blinded study.
Principal Investigator: Nirav Thosani, MD, MHA & Songlin Zhang, MD
Main inclusion criteria:

  • Have EUS finding of a Pancreatic Solid lesion
  • Do not have contraindications for FNA/FNB.

EUS-RFA Pancardinal Trial
Endoscopic Ultrasound Pancreatic Cancer Radiofrequency Ablation: A Phase II PANCARDINAL-1 Trial.
Principal Investigator: Nirav Thosani, MD, MHA & Curtis Wray, MD
Co-investigator: Curtis Wray, MD
Main inclusion criteria:

  • Male or Female patients > 18 years of age
  • Diagnosed and histologically confirmed PDAC by biopsy
  • Permanent street address and consent to study participation
  • Axial CT scan consistent with PDAC
  • No prior chemotherapy or less than 2 months of pre-operative chemotherapy for PDAC.
  • ECOG performance status 0-2

Upper GI Endoscopy:

RFA for GAVE
Prospective Evaluation of Outcomes for Patients Undergoing Radiofrequency Ablation (RFA) Using HALO Ultra Device for Gastric Antral Vascular Ectasia (GAVE)

Principal Investigator: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • In-ward patients
  • Patients diagnosed with GAVE
  • Patients undergoing radiofrequency ablation with HALO ULTRA device at Memorial Hermann Hospital (TMC)-GI lab.

Outcomes of PEG Tube Placement (Retrospective)
Effect of Continuous Anticoagulation and Antiplatelet Therapy on the Incidence of Bleeding and Other Adverse Events following Placement of Percutaneous Endoscopic Gastrostomy (PEG) Tube: A Retrospective Chart Review
Principal Investigator: Nirav Thosani, MD, MHA
Summary:
– To evaluate the rate of incidence of bleeding in patients who undergo PEG tube placement.
– To determine whether anticoagulation and anti-platelet therapy influence incidence of bleeding in patients undergoing PEG tube placement
– To determine other factors that influence incidence of serious adverse events following PEG tube placement.

Cardiac Implantable Devices and Gastrointestinal Bleeding (Retrospective)
Effect of Cardiac Intervention and Implanted devices on the Incidence of Gastrointestinal Bleeding and other Adverse Events: A retrospective Study.
Principal Investigator: Nirav Thosani, MD, MHA
Summary:
We intend to assess the burden of the GI complications following cardiac interventions and/or implantation of cardiac devices. This study will also evaluate the incidence, predictors, and prognostic determinants of these adverse events and the association with the type of cardiac intervention and degree of hemodynamic instability.

Zenker’s Myotomy Retrospective
Outcomes of Flexible Endoscopic Incisional Therapy of Zenker’s Diverticulum: A Retrospective Chart Review.
Principal Investigator: Nirav Thosani, MD, MHA
Summary:
The aim of the proposed study is to retrospectively assess technical success, clinical success, and adverse events after endoscopic myotomy. Technical success will be defined as ability to successfully complete the endoscopic myotomy. Clinical success will be defined as symptom relief and objective improvement which will be assessed with esophagram, upper GI barium study, or CT scan, routinely performed post-procedure for clinical care. Adverse events will be recorded per published ASGE criteria.

 

The C2D2 Trial
Safety and Efficacy of the CryoBalloon Ablation for Treatment of Sporadic and Familial Nonampullary Nonpolypoid Duodenal Adenomas.
Principal Investigator: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • Biopsy-proven adenoma (tubular, tubulovillous, or villous) in the first or second portion of the duodenum, histology within 6 months.
  • Size and morphology characteristics – Maximum diameter between 1 and 5 cm.
  • Maximum height 2 mm, or 1 closed biopsy forceps width (Paris 2A, Paris 2B).
    • Lesion involving < 3 duodenal folds or – Lesion involving no more than 50% circumference
  • Older than 18 years of age at time of consent.
  • Provides written informed consent on the IRB-approved informed consent form.
  • Willing and able to comply with study requirements for follow-up.

TIF Heartburn Registry
A multi-center, multi-year registry of patients with Gastroesophageal Reflux Disease (GERD) undergoing diagnostic evaluation and/or treatment of GERD and associated diseases and complications.
Principal Investigator: Nirav Thosani, MD, MHA
Summary:
This purpose of this research study is to establish a registry with collected data related to patients undergoing diagnostic evaluation and treatment of GERD and its associated diseases in multiple academic and community settings. This study aims in particular to evaluate treatment results for patients treated with an endoscopic antireflux procedure called transoral incisionless fundoplication (TIF) for least 5 years.

NO-FEAR BE (Awaiting Approval)
Safety and Efficacy of the CryoBalloon Ablation for Treatment of Patients with Resistant Barrett’s Esophagus (BE) – The Resistant BE Trial (ReBET) & Nitrous Oxide for Endoscopic Ablation of Refractory Barrett’s Esophagus.
Principal Investigator: Nirav Thosani, MD, MHA
Main inclusion criteria:

  • History of BE with LGD or HGD confirmed with biopsy.
  • Prior treatment with RFA who meet either of the following criteria at the enrolling EGD:
    • History of at least 3 RFA treatments, with one of the following:
      1. Residual BE Prague C1 – C3 and/or
      2. Residual BE >M1 – M8 and/or
      3. One or more islands of residual BE >1 cm in diameter
      4. Any residual dysplasia in tubular esophagus
        1. History of at least 2 RFA treatments and < 50% eradication of BE, as judged by estimation
          of the treating physician.
      5. 18 or older years of age at time of consent.
      6. Willing to undergo an alternative approved standard of care treatment for their condition.
      7. Willing and able to comply with study requirements for follow-up.
      8. No prior history of balloon or spray cryotherapy esophageal treatment.

Quality in Endoscopy

Quality Metrics in Endoscopy
A prospective study to establish Quality Metrics in Endoscopy in order to demonstrate competence and help define areas of continuous quality improvement.
Principal Investigator: Nirav Thosani, MD, MHA
Summary:
This is a prospective study to develop a framework to measure the components of quality of health care which will be crucial to identify patterns of competence and identify areas of continued improvement.

Colon Polyp QI Study
Colon polyp detection study: A quality improvement initiative
Principal Investigator: Sushovan Guha, MD, PhD
Summary:
This is a prospective study to develop a framework to measure the components of quality of health care which will be crucial to identify patterns of competence and identify areas of continued improvement.