Trial Outcomes & Findings for Self-Propelled Versus Standard Percutaneous Endoscopic Gastrojejunostomy(PEG-J); RCT (NCT NCT01892267)

Results Overview

Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

19 participants

Primary outcome timeframe

From date of placement up to 4 weeks

Results posted on

2017-05-17

Participant Flow

Patients were enrolled between 7/1/13 and 4/14/14 in an academic tertiary center

Participant milestones

Participant milestones
Measure	Self-propelled PEGJ Feeding Tube Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement	Standard PEGJ Feeding Tube Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement
Overall Study STARTED	9	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Self-propelled PEGJ Feeding Tube n=9 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement	Standard PEGJ Feeding Tube n=10 Participants Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement	Total n=19 Participants Total of all reporting groups
Gastrointestinal Quality of Life Index (GIQLI) score	78.2 units on a scale STANDARD_DEVIATION 27.1 • n=99 Participants	69.1 units on a scale STANDARD_DEVIATION 11.9 • n=107 Participants	73.4 units on a scale STANDARD_DEVIATION 20.5 • n=206 Participants
Age, Continuous	62.22 years STANDARD_DEVIATION 13.30 • n=99 Participants	52 years STANDARD_DEVIATION 10.68 • n=107 Participants	56.84 years STANDARD_DEVIATION 12.77 • n=206 Participants
Sex/Gender, Customized Female	4 participants n=99 Participants	8 participants n=107 Participants	12 participants n=206 Participants
Sex/Gender, Customized Male	5 participants n=99 Participants	2 participants n=107 Participants	7 participants n=206 Participants

PRIMARY outcome

Timeframe: From date of placement up to 4 weeks

Number of participants in whom migration was assessed by X-ray at 4 weeks post-intervention.

Outcome measures

Outcome measures
Measure	Self-propelled PEGJ Feeding Tube n=9 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement	Standard PEGJ Feeding Tube n=10 Participants Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement
Number of Participants With PEG-J Tube Migration	3 participants	3 participants

SECONDARY outcome

Timeframe: 4 weeks

Patiens who will have retrograde PEG-J tube migration will get repeat endoscopy for PEG-J tube placement

Outcome measures

Outcome measures
Measure	Self-propelled PEGJ Feeding Tube n=9 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement	Standard PEGJ Feeding Tube n=10 Participants Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement
Repeat Endoscopy for Feeding Tube Placement Due to Retrograde Tube Migration	3 participants	3 participants

SECONDARY outcome

Timeframe: 2 years

Population: Study terminated prematurely, so that the appropriate follow-up data was not collected.

Determine tube patency which is defined as time period between tube placement and need for re-intervention.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Intra-procedural

Success of tube placement in the desired location as determined endoscopically.

Outcome measures

Outcome measures
Measure	Self-propelled PEGJ Feeding Tube n=9 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement	Standard PEGJ Feeding Tube n=10 Participants Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement
Technical Success	8 procedure	10 procedure

SECONDARY outcome

Timeframe: Intra-procedural

Time required from introduction of the upper endoscope until placement of the feeding tube.

Outcome measures

Outcome measures
Measure	Self-propelled PEGJ Feeding Tube n=9 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement	Standard PEGJ Feeding Tube n=10 Participants Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement
Intervention Time	17.2 minute Standard Deviation 12.3	28.7 minute Standard Deviation 13.6

SECONDARY outcome

Timeframe: 2 years

Population: Study terminated prematurely, so that the appropriate follow-up data was not collected.

If repeate endocopy and tube placement are needed due to clogging or retrograde migration

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Inra-procedural

Scored by the endoscopist on a 10-point Visual Analogue Scale with zero being "without difficulty" and 10 being "maximum difficulty". The lower the score, the better the outcome.

Outcome measures

Outcome measures
Measure	Self-propelled PEGJ Feeding Tube n=9 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement	Standard PEGJ Feeding Tube n=10 Participants Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement
Difficulty of the Procedure	6.2 units on a scale Standard Deviation 3.8	7 units on a scale Standard Deviation 2.2

SECONDARY outcome

Timeframe: 3 month

Population: The discrepancy between the number of analyzed patients and the number of patients in the Participant Flow section is due to the fact that only 5 patients had a completed GIQLI questionnaire at 3-month follow-up.

Gastrointestinal Quality of Life Index (GIQLI) score ranging from 0 (worst quality of life possible with severe digestive symptoms) to 144 (optimal quality of life without symptoms

Outcome measures

Outcome measures
Measure	Self-propelled PEGJ Feeding Tube n=2 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement	Standard PEGJ Feeding Tube n=3 Participants Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement
Gastrointestinal Quality of Life Index (GIQLI) Score	106 units on a scale Interval 72.0 to 140.0	75 units on a scale Interval 59.0 to 80.0

SECONDARY outcome

Timeframe: One week

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.

Outcome measures

Outcome measures
Measure	Self-propelled PEGJ Feeding Tube n=9 Participants Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement	Standard PEGJ Feeding Tube n=10 Participants Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement
Short-term Complications	2 participants	3 participants

SECONDARY outcome

Timeframe: 2 years

Population: Study terminated prematurely, so that the appropriate follow-up data was not collected.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Study terminated prematurely, so that the appropriate follow-up data was not collected.

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)

Outcome measures

Outcome data not reported

Adverse Events

Self-propelled PEGJ Feeding Tube

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Standard PEGJ Feeding Tube

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Self-propelled PEGJ Feeding Tube n=9 participants at risk Patients in this arm will receive self-propelled balloon PEGJ tube. PEG-J placement: PEG-J placement	Standard PEGJ Feeding Tube n=10 participants at risk Patients in this arm will receive the standard commercially availabel PEGJ tube. PEG-J placement: PEG-J placement
Gastrointestinal disorders Nausea after tube placement	55.6% 5/9	30.0% 3/10
Gastrointestinal disorders vomiting after tube placement	22.2% 2/9	20.0% 2/10

Additional Information

Dr. Mouen Khashab

Johns Hopkins Hospital

Phone: 443-287-1960

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place