Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT

Feeding Tube Clinical Trial

Official title:

Comparison Outcomes and Complications of Self-Propelled vs. Standard Percutaneous Endoscopic Gastrojejunostomy (PEG-J); a Randomized Single Blind Clinical Trial

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01892267
• Other study ID #: NA_00079056
• Status: Suspended
• Phase: Phase 2
• First received: July 1, 2013
• Last updated: January 22, 2015
• Start date: July 2013
• Est. completion date: July 2015

Study information

• Verified date: January 2015
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Our main hypothesis is that self-propelled Percutaneous Endoscopic Gastrojejunostomy tube (PEG-J) that has a balloon on it's tip is associated with lower J-tube retrograde migration rate, and lower rates of short- and long-term complications when compared to standard PEGJ feeding tubes.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 60
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Consecutive adult patients (18-80 years of age) with 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.

Exclusion Criteria:

• Unable to give informed consent

• Pregnant or breastfeeding women (all women of child-bearing age will undergo urine pregnancy testing)

• Acute gastrointestinal bleeding

• Coagulopathy defined by prothrombin time < 50% of control; PTT > 50 sec, or INR > 1.5), on chronic anticoagulation, or platelet count <50,000

• Inability to tolerate sedated upper endoscopy due to cardio-pulmonary instability or other contraindication to endoscopy

• Cirrhosis with portal hypertension, varices, and/or ascites

• Allergy to egg

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Feeding Tube

Intervention

Device:
• PEG-J placement
PEG-J placement

Locations

Country	Name	City	State
United States	Johns Hopkins Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PEG-J Tube migration rate	Tube migration will be assessed by X-ray at 4 weeks post-intervention.	From date of placement up to 4 weeks	No
Secondary	Repeat endoscopy for feeding tube placement due to retrograde tube migration	Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement	4 weeks	No
Secondary	Patency of feeding tube	Determine tube patency which is defined as time period between tube placement and need for re-intervention.	2 years	No
Secondary	Technical success	Success of tube placement in the desired location as determined endoscopically.	Intra-procedural	No
Secondary	Intervention time	Time required from introduction of the upper endoscope until placement of the feeding tube.	Intra-procedural	No
Secondary	Time to repeat endoscopy for tube replacement	If repeate endocopy and tube placement are needed due to clogging or retrograde migration	2 years	No
Secondary	Difficulty of the procedure	Scored by the endoscopist on a 10-point Visual Analogue Scale)	Inra-procedural	No
Secondary	Gastrointestinal Quality of Life Index (GIQLI) score	Patients` quality of life will be assessed using a specific scoring system for digestive diseases.4 The score is based on the results of a self-administered questionnaire using 36 items related to digestive symptoms and quality of life, including nausea, bloating, abdominal pain, regurgitation and appetite. Each item is rated from 0 to 4 (0=extremely severe, 1=severe, 2=moderate, 3=mild and 4=absent). The overall GIQLI score is calculated by adding the scores for each item and varies from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms). Patients will fill GIQLI at baseline and 1, 2 and 3 months after procedure.	3 months	No
Secondary	Short-term complications	Short-term complications will include stomal (Infection, erythema, bleeding, pain and secretion, etc) and tube (Clotting, dislocation, defect, aspiration, etc) complications detected in the first week.	2 years	Yes
Secondary	Long-term complications	Long-term complications will include stomal (Infection, erythema, bleeding, pain, secretion, abscess, etc) and tube (Clotting, dislocation, defect and aspiration, etc) complications detected more than one week after intervention.	2 years	Yes
Secondary	Direct cost	Cost will be determined according to Medicare reimbursement of billed CPT codes. The cost of all related follow-up procedures will be included (e.g. cost of standard PEGJ in case of failed Self-propelled PEGJ feeding tube, cost of managing complications, cost of re-intervention in case of tube dysfunction, etc)	2 years	No