Clinical Trials in the Division of Gastroenterology

Condition: Cyclic Vomiting
Study title: Prospective Registry in Cyclic Vomiting Syndrome at MGH
Description of study: The researchers are looking for people to take part in the Cyclic Vomiting Syndrome Prospective Registry Study. They are exploring the causes, progression, and impact of the disease.
Basic eligibility criteria: Diagnosed with CVS and 18 years of age or older
Principal Investigator: Braden Kuo, MD
Contact: Mariana Almeida; 617-724-0480

Condition: Cyclic Vomiting Syndrome
Study title: Resting State Brain Response to Chronic Nausea and Cuff Pain
Description of study: The proposed study will examine the CNS circuitry of nausea in the human brain. Results found from motion sickness studies in healthy adults will be applied to guide the analysis of brain physiology in patients suffering from chronic nausea, i.e. cyclic vomiting syndrome (CVS).
Basic eligibility criteria: This study will aim to evaluate patients (n=25) diagnosed with CVS who are in an inter-ictal phase, i.e. at least 48 hours following cessation of any nausea/vomiting episode.

1. Subjects age 18 to 80 years
2. Diagnosis of Cyclic Vomiting Syndrome by Rome III criteria

EXCLUSION: Subjects who currently have an acute illness, those who are awaiting transplantation, and those who have a chronic illness, such as kidney failure, congestive heart failure, and diabetes. Use of prescription benzodiazepines within the previous 3 days, use of prescription opioids and self-reported use of cannabinoids within the previous 7 days are another exclusion criteria. Another exclusion criterion is any nausea/vomiting episode within 48 hours prior to experimental session.

Principal Investigator: Braden Kuo, MD
Contact: Mariana Almedia; 617-724-0480

Condition: Gastroparesis
Study title: Non-Invasive Characterization of Gastric Motility Using MRI
Description of study: This research study is being done to help us better understand functional dyspepsia, which is upper abdominal pain or discomfort, frequently related to meals.
Basic eligibility criteria: Women cannot be pregnant or plan to become pregnant during the study, no previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, or iron overload disorders, no metal or magnetic implants (such as metallic clips in the brain or cardiac pacemakers).
Principal Investigator: Braden Kuo, MD C
Contact: Shahar Castel; 617-726-0196 Condition: Gastroparesis

Study title: A Pilot Study on the Efficacy and Safety of Olanzapine in Improving Symptoms and Gastric Motility in Gastroparesis
Description of study:
Aim 1: Investigate the efficacy and safety of olanzapine in the treatment of non-diabetic gastroparesis.
Aim 2: Determine whether olanzapine has prokinetic effects on gastric emptying in gastroparesis.
Aim 3: Examine the effects of olanzapine on neurohumoral regulation of eating and appetite. Basic eligibility criteria: This is a pilot study of 20 consecutive subjects ages 18 – 65 with documented delayed gastric emptying within the past 2 years and history of nausea, vomiting, bloating, anorexia, early satiation, post-prandial fullness, and weight loss for at least 6 months without structural or organic cause will be enrolled.

Principal Investigator: Braden Kuo, MD
Contact: Shahar Castel; 617-726-0196

Ongoing clinical trials for gastroparesis: No longer recruiting

Study title: A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase II Study to Evaluate the Safety and Efficacy and Dose Response of 28 Days of Once-Daily Dosing of the Oral Motilin Receptor Agonist GSK962040, in Type I and II Diabetic Male and Female Subjects with Gastroparesis
Description of study: The purpose of this research study is to test an experimental drug called GSK962040. The researchers want to see if the drug can improve the time of stomach emptying (food and drink emptying from the stomach) in people with diabetes. These people also have a stomach condition called gastroparesis, which means partial paralysis of the stomach. We also want to see if the drug will cause side effects.
Principal investigator: Braden Kuo, MD

Condition: Irritable bowel syndrome
Study title: A Randomized, Double-blind, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-27018966 in the Treatment of Patients With Diarrhea-Predominant Irritable Bowel Syndrome
Description of study: We are doing this research study to find out if a new drug, JNJ-27018966, can help people with irritable bowel syndrome with diarrhea (IBS-d). People with IBS-d have abdominal discomfort or pain along with frequent diarrhea. We also want to find out if JNJ-27018966 is safe to take without causing too many side effects. The primary objectives of this study are:
1. To evaluate the clinical response of patients with IBS-d to JNJ-27018966, relative to placebo
2. To evaluate the overall safety and tolerability of JNJ-27018966 in the treatment of IBS-d

The secondary objective of this study is to further evaluate the treatment effect of JNJ- 27018966 relative to placebo based on patient reports of IBS-d symptoms (abdominal pain, abdominal bloating, stool consistency, global symptom scores, adequate relief), bowel functioning, and quality of life.

Basic eligibility criteria:
1. Between the ages of 18-80
2. Patients suffering from IBS-d (diarrhea predominant irritable bowel syndrome)
3. Suffering from abdominal pain, bloating, diarrhea

Principal Investigator: Braden Kuo, MD
Contact: Shahar Castel; 617-726-0196

Condition: Neuroendocrine tumors
Study title: Collection of Biologic Samples and Clinical Data in Patients with Neuroendocrine Tumors
Description of study: To establish a comprehensive system to collect, catalogue, and store biological specimens from patients with neuroendocrine tumors.
Basic eligibility criteria: Diagnosis of carcinoid tumor or pancreatic neuroendocrine tumor; Adult Age Range: 18+
Principal Investigator: Daniel C. Chung, MD
Contact: Lara Novak; 617-726-0161

Condition: Family History of Pancreatic Cancer
Study title: Management and Follow-up of High-Risk Individuals and Families with Hereditary Pancreatic Cancer
Description of study: To create a database of subjects and families with a hereditary pattern of pancreatic cancer in order to measure outcomes among those who undergo radiologic and endoscopic screening. 
Basic eligibility criteria: Individuals with a family history of at least two first-degree relatives with primary site pancreatic cancer; individuals with a family history of at least three relatives with primary site pancreatic cancer independent of degree; individuals with two relatives with primary site pancreatic cancer who are first-degree related to each other, one of whom is a first-degree relative of the participant; individuals with Lynch syndrome, PALB2, ATM, BRCA1 or BRCA2 gene mutations with at least one relative with primary site pancreatic cancer; individuals with Peutz-Jeghers Syndrome; individuals with Hereditary Pancreatitis; individuals with a p16/FAMMM or p53 gene mutation.
Principal Investigator: Daniel C. Chung, MD
Contact: Madeline Friedman; 617-726-1355

Condition: Pancreatic cystic lesions
Study title: Optimization of storage and shipment conditions for pancreatic cystic fluid specimens
Description of study: This study will help us to determine the optimal preservative solution for shipment and storage of the pancreatic cyst fluids. Leftover pancreatic cystic fluid will be collected and stored. Three different preservative solutions will be compared to the snap-frozen technique.
Basic eligibility criteria: Patients undergoing an endoscopic fine needle aspiration for pancreatic cystic lesion, over the age of 18. Leftover cystic fluid will be studied in four different storage and shipment conditions.
Principal Investigator: William Brugge, MD
Contact: Ebubekir S. Daglilar, MD, CRC; 6617-724-0462

Condition: Pancreatic cystic lesions
Study title: EUS-Guided Injection of Albumin-bound Paclitaxel into Pancreatic Cysts: A Pilot Study
Description of study: The goal of the study is to determine the safety of injection of albumin-bound paclitaxel into pancreatic cysts to treat pancreatic cystic lesions that are not eligible for surgical resection.
Basic eligibility criteria: Abdominal CT imaging within 6 months with diagnosed pancreatic cystic lesion, over the age of 18.
Principal Investigator: William Brugge, MD
Contact: Ebubekir S. Daglilar, MD, CRC; 6617-724-0462
For more information: Visit the Clinical Trials website at the National Institutes of Health

Condition: Pancreatic cystic lesions
Study title: Establishment of Database of Patients with Pancreatic Cystic Lesions Who Underwent Endoscopic Ultrasound-guided Fine Needle Aspiration
Description of study: The goal of this study is to create a database of subjects with a pancreatic cystic lesion in order to measure outcomes among those who undergo radiologic and endoscopic fine needle aspiration.
Basic eligibility criteria: Patients undergoing an endoscopic fine needle aspiration for pancreatic cystic lesion
Principal Investigator: William Brugge, MD
Contact: Ebubekir S. Daglilar, MD, CRC; 6617-724-0462

Condition: Pancreatic cystic lesions
Study title: Differentiation between low- and high-risk pancreatic cystic lesions with optical coherence tomography imaging
Description of study: The goal of this study is to develop an imaging probe and image processing methods for pancreatic cystic lesions. This new imaging method will provide equivalent or superior diagnostic information relative to visual inspection of endosonography. The specific aim of this study is to determine the accuracy of OCT imaging for differentiation between low and high risk pancreatic cystic lesions. Patients who undergo endoscopic ultrasound imaging for evaluation of pancreatic cystic lesions will undergo optical coherence tomography imaging in the same session.
Basic eligibility criteria: Patients who will undergo endoscopic ultrasound imaging for evaluation of pancreatic cystic lesion
Principal Investigator: William Brugge, MD
Contact: Ebubekir S. Daglilar, MD, CRC; 6617-724-0462

Condition: Cholangiocarcinoma, pancreatic cancer
Study title: Endoscopic Radiofrequency Ablation of Malignant Bile Duct Strictures: A pilot study
Description of study: This is a prospective pilot study of endoscopic ablation of a malignant bile duct stricture with ERCP guided radiofrequency ablation. Patients undergo one treatment during ERCP and resume their standard medical or surgical care after the procedure.
Basic eligibility criteria: Patients must have evidence of biliary obstruction by imaging and laboratory testing, as well as evidence of malignancy.
Principal Investigator: William Brugge, MD
Contact: Ebubekir Daglilar, MD, CRC; 617-724-0462
For more information: Visit the Clinical Trials website at the National Institutes of Health

Condition: Pancreatic cystic lesions
Study title: Optimization of storage and shipment conditions for pancreatic cystic fluid specimens
Description of study: This study will help us to determine the optimal preservative solution for shipment and storage of the pancreatic cyst fluids. Leftover pancreatic cystic fluid will be collected and stored. Three different preservative solutions will be compared to the snap-frozen technique.
Basic eligibility criteria: Patients undergoing an endoscopic fine needle aspiration for pancreatic cystic lesion, over the age of 18. Leftover cystic fluid will be studied in four different storage and shipment conditions.
Principal Investigator: William Brugge, MD
Contact: Ebubekir S. Daglilar, MD, CRC; 6617-724-0462

Condition: Pancreatic cystic lesions
Study title: EUS-Guided Injection of Albumin-bound Paclitaxel into Pancreatic Cysts: A Pilot Study
Description of study: The goal of the study is to determine the safety of injection of albumin-bound paclitaxel into pancreatic cysts to treat pancreatic cystic lesions that are not eligible for surgical resection.
Basic eligibility criteria: Abdominal CT imaging within 6 months with diagnosed pancreatic cystic lesion, over the age of 18.
Principal Investigator: William Brugge, MD
Contact: Ebubekir S. Daglilar, MD, CRC; 6617-724-0462
For more information: Visit the Clinical Trials website at the National Institutes of Health

Condition: Pancreatic cystic lesions
Study title: Establishment of Database of Patients with Pancreatic Cystic Lesions Who Underwent Endoscopic Ultrasound-guided Fine Needle Aspiration
Description of study: The goal of this study is to create a database of subjects with a pancreatic cystic lesion in order to measure outcomes among those who undergo radiologic and endoscopic fine needle aspiration.
Basic eligibility criteria: Patients undergoing an endoscopic fine needle aspiration for pancreatic cystic lesion
Principal Investigator: William Brugge, MD
Contact: Ebubekir S. Daglilar, MD, CRC; 6617-724-0462

Condition: Pancreatic cystic lesions
Study title: Differentiation between low- and high-risk pancreatic cystic lesions with optical coherence tomography imaging
Description of study: The goal of this study is to develop an imaging probe and image processing methods for pancreatic cystic lesions. This new imaging method will provide equivalent or superior diagnostic information relative to visual inspection of endosonography. The specific aim of this study is to determine the accuracy of OCT imaging for differentiation between low and high risk pancreatic cystic lesions. Patients who undergo endoscopic ultrasound imaging for evaluation of pancreatic cystic lesions will undergo optical coherence tomography imaging in the same session.
Basic eligibility criteria: Patients who will undergo endoscopic ultrasound imaging for evaluation of pancreatic cystic lesion
Principal Investigator: William Brugge, MD
Contact: Ebubekir S. Daglilar, MD, CRC; 6617-724-0462