Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J)

Self-Propelled Percutaneous Endoscopic GastroJejunostomy (PEG-J): A Pilot Study

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.

Study Overview

• Status: Terminated
• Conditions: GERD
• Intervention / Treatment: Device: PEGJ 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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PEGJ; Patients in this arm will receive self-propelled balloon PEGJ tube.	Device: PEGJ tube; The self-propelled PEGJ feeding tube

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Number of Participants With Adverse Events	One week after the procedure patients were called by one of the study investigators and were asked whether or not they had Abdominal pain, Nausea or Vomiting after the procedure.	From date of PEGJ placement up to 3 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Retrograde Migration of PEGJ Feeding Tube Within 3 Weeks of Placement	An Abdominal X-ray was obtained 3 weeks after the procedure to check whether or not there was any PEGJ feeding tube migration.	From date of PEGJ placement up to 3 weeks

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: GI Supply
• Investigators: Principal Investigator: Mouen Khashab, MD, Johns Hopkins Hospital Department of Gastroenterology

Publications and helpful links

General Publications

• Kim KJ, Victor D, Stein E, Valeshabad AK, Saxena P, Singh VK, Lennon AM, Clarke JO, Khashab MA. A novel ballooned-tip percutaneous endoscopic gastrojejunostomy tube: a pilot study. Gastrointest Endosc. 2013 Jul;78(1):154-7. doi: 10.1016/j.gie.2013.03.005. Epub 2013 Apr 24.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: February 29, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 12, 2012

Study Record Updates

• Last Update Posted (Actual): March 31, 2017
• Last Update Submitted That Met QC Criteria: March 2, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: GERD; stroke; respiratory failure; acute pancreatitis; gastroparesis; balloon; feeding tube; percutaneous endoscopic gastrostomy; PEGJ; PEG-J; self-propelled
• Other Study ID Numbers: NA_00048369