Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)

This study has been terminated.
(Proof of principle was achieved after inclusion of 7 patients)
Sponsor:
Collaborator:
GI Supply
Information provided by (Responsible Party):
Mouen Khashab, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT01551095
First received: February 29, 2012
Last updated: June 28, 2013
Last verified: June 2013
  Purpose

This research is being done to study the safety of an investigational percutaneous endoscopic gastrojejunostomy (PEGJ) tube and whether the addition of a balloon on the end of the J tube prevents it from slipping back into the stomach.


Condition Intervention Phase
GERD
Device: PEGJ tube
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J): A Pilot Study

Resource links provided by NLM:


Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Safety: Number of Participants with Adverse Events [ Time Frame: From date of PEGJ placement up to 3 weeks ] [ Designated as safety issue: Yes ]
    Complications as a result of the PEGJ will be assessed (pain, vomiting, nausea)


Secondary Outcome Measures:
  • Migration of PEGJ feeding tube [ Time Frame: From date of PEGJ placement up to 3 weeks ] [ Designated as safety issue: No ]
    Risk of retrograde migration within 3 weeks of placement


Enrollment: 7
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEGJ
Patients in this arm will receive self-propelled balloon PEGJ tube.
Device: PEGJ tube
The self-propelled PEGJ feeding tube

Detailed Description:

The word "investigational" means the PEGJ feeding tube used in this study is not approved by the U. S. Food and Drug Administration (FDA) and is still being tested in research studies. Currently commercially available PEGJ tubes are long tubes which are placed into the part of the small intestine that connects to the stomach (duodenum) under endoscopic guidance. The tip of these PEGJ tubes usually have some built-in extra weight (several grams), which theoretically should prevent slippage of the tube back into the stomach. However, these tubes usually cannot be placed very far into the duodenum and the build-in weight is usually not sufficient to keep the tube in place.

The tip of the currently commercially available PEGJ tubes often (usually within 1-2 weeks) migrates back into the stomach and at that point the tube needs to be replaced. The investigational PEGJ feeding tube used in this study is self-propelled and has a balloon on its tip. The tip of this tube is directed endoscopically through the part of the stomach that connects to the duodenum (pylorus), then the balloon is filled with 5 cc of water and the endoscope is removed. The water filled balloon then is carried by the movement of the intestinal muscles through the duodenum into the middle section of the small intestine (jejunum). It is hoped that such a deep position of the tip of the self-propelled PEGJ tube and presence of the water-filled balloon on its tip will prevent migration of the tube back into the stomach and therefore eliminates the need for tube replacement.

The only difference between the currently approved PEGJ feeding tube and the investigational one being used in this study is the addition of the balloon to the tip of the J port. People who come to Johns Hopkins Hospital for PEGJ placement as part of standard clinical care and who are not pregnant may join the study.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18-90 years
  • need for post-pyloric feeding (patients unable to eat due to stroke, intubated patients with respiratory failure, patients with acute pancreatitis, etc)
  • ability to give informed consent for the study

Exclusion Criteria:

  • patients with uncorrectable bleeding disorders (INR more than 1.5, platelet count less than 50,000)
  • inability to get informed consent for the study from patients or their families
  • pregnancy (all women of child-bearing age will undergo urine pregnancy testing)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551095

Locations
United States, Maryland
Johns Hopkins Hospital
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
GI Supply
Investigators
Principal Investigator: Mouen Khashab, MD Johns Hopkins Hospital Department of Gastroenterology
  More Information

No publications provided by Johns Hopkins University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mouen Khashab, Assistant Professor of Medicine; Director of Therapeutic Endoscopy, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01551095     History of Changes
Other Study ID Numbers: NA_00048369
Study First Received: February 29, 2012
Last Updated: June 28, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
PEGJ
PEG-J
percutaneous endoscopic gastrostomy
feeding tube
gastroparesis
acute pancreatitis
stroke
respiratory failure
GERD
balloon
self-propelled

ClinicalTrials.gov processed this record on October 21, 2014