Percutaneous Endoscopic Gastrostomy Versus Percutaneous Endoscopic Gastrostomy With Jejunal Extension

NCT06717321 | Terminated

• 1 other identifier: 23-170
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if placing a feeding tube with a small bowel extension (called Percutaneous Endoscopic Gastrostomy With Jejunal Extension \[PEG-J\]) is better at preventing pneumonia than a standard feeding tube (called Percutaneous Endoscopic Gastrostomy \[PEG\]) in people who need long-term tube feeding. Researchers want to know if people who receive a PEG-J have fewer cases of pneumonia in the first 30 days compared to those who receive a standard PEG, and whether PEG-J tubes require more follow-up procedures to fix tube problems. Researchers will compare two different types of feeding tubes: a standard feeding tube that goes into the stomach (PEG) versus a feeding tube that extends past the stomach into the small intestine (PEG-J). This will help determine which type of feeding tube is safer and works better for patients. Participants will be randomly assigned to receive either a PEG or PEG-J feeding tube through a minimally invasive procedure. They will start receiving nutrition through the tube 24 hours after placement and be monitored for 30 days to check for problems like pneumonia or tube malfunction, while receiving regular medical care from their treating doctors. The study is open to people who are 18 years or older and need a new feeding tube for long-term nutrition. People cannot take part if they have pneumonia, COVID-19, an existing feeding tube, previous stomach surgery, gastroparesis (a condition affecting stomach movement), digestive system blockage, are pregnant, or are in prison. All participants must understand English. Participation is voluntary, and participants can leave the study at any time. The study team will carefully monitor all participants for any problems throughout the 30-day period

Conditions

Aspiration Pneumonias; Tube Feeding; Enteral Feeds

Keywords

tube feeds; aspiration pneumonia; peg; peg-J; enteral feeding

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Developed Post-Procedure Pneumonia

  Diagnosis of pneumonia will be determined based on clinical judgment of the treating provider and must be explicitly documented as "pneumonia" in the medical record.

  From day of procedure (day 0) through 30 days post-procedure

Secondary Outcomes (3)

• Number of Participants Requiring Additional Procedures Due to Tube Malfunction

  From day of procedure (day 0) through 30 days post-procedure

• Number of Participants with Post-Operative Complications

  From day of procedure (day 0) through 30 days post-procedure

• Total Procedure Time in Minutes from Start to Completion of Feeding Tube Placement

  Day of procedure

Study Arms (2)

PEG arm: Patients receiving the 20-French pull-type PEG tube

ACTIVE COMPARATOR

PEG Arm: Participants receive a 20-French pull-type percutaneous endoscopic gastrostomy tube placed into the stomach using standard safe track technique with transillumination and 1:1 finger indentation. The tube is positioned midway between the greater and lesser curves of the stomach. Continuous tube feeds begin 24 hours after placement. Follow-up period is 30 days.

Procedure: (Arm 1): PEG

PEG-J arm: Patients receiving the 24-French pull-type PEG with 12-French jejunal extension tube

ACTIVE COMPARATOR

Participants receive a 24-French pull-type percutaneous endoscopic gastrostomy tube with a 12-French jejunal extension. After standard PEG placement, the jejunal extension tube is advanced past the pylorus and secured to the small bowel wall with endoclips as indicated. Continuous tube feeds begin 24 hours after placement. Follow-up period is 30 days.

Procedure: (Arm 2): PEG-J

Interventions

(Arm 1): PEG PROCEDURE

A 20-French pull type percutaneous endoscopic feeding tube placed into the stomach using endoscopic guidance

PEG arm: Patients receiving the 20-French pull-type PEG tube

(Arm 2): PEG-J PROCEDURE

24-French pull type percutaneous endoscopic feeding tube placed into the stomach with a 12-French jejunal extension tube advanced through the PEG and positioned post-pyloric in the small bowel using endoscopic guidance

PEG-J arm: Patients receiving the 24-French pull-type PEG with 12-French jejunal extension tube

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Requires feeding access as determined by treating provider

You may not qualify if:

• Concurrent pneumonia at time of enrollment
• Concurrent COVID-19 diagnosis
• Prior feeding access (transabdominal feeding access)
• Prior upper gastrointestinal surgery (previous gastric resection surgery)
• Gastroparesis
• Obstruction or pseudo-obstruction
• Pregnancy
• Contraindication to undergo upper endoscopy
• Prisoners
• Primary language is not English

Sponsors & Collaborators

• Jerry Dang: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related Publications (6)

• Fox KA, Mularski RA, Sarfati MR, Brooks ME, Warneke JA, Hunter GC, Rappaport WD. Aspiration pneumonia following surgically placed feeding tubes. Am J Surg. 1995 Dec;170(6):564-6; discussion 566-7. doi: 10.1016/s0002-9610(99)80016-6.

  PMID: 7492001 BACKGROUND

• Chang WK, Huang HH, Lin HH, Tsai CL. Evaluation of Oropharyngeal Dysphagia in Patients Who Underwent Percutaneous Endoscopic Gastrostomy: Stratification Risk of Pneumonia. JPEN J Parenter Enteral Nutr. 2020 Feb;44(2):239-245. doi: 10.1002/jpen.1592. Epub 2019 Apr 14.

  PMID: 30983013 BACKGROUND

• Gauderer MW, Ponsky JL, Izant RJ Jr. Gastrostomy without laparotomy: a percutaneous endoscopic technique. J Pediatr Surg. 1980 Dec;15(6):872-5. doi: 10.1016/s0022-3468(80)80296-x.

  PMID: 6780678 BACKGROUND

• Minard G. The history of surgically placed feeding tubes. Nutr Clin Pract. 2006 Dec;21(6):626-33. doi: 10.1177/0115426506021006626.

  PMID: 17119170 BACKGROUND

• Seres DS, Valcarcel M, Guillaume A. Advantages of enteral nutrition over parenteral nutrition. Therap Adv Gastroenterol. 2013 Mar;6(2):157-67. doi: 10.1177/1756283X12467564.

  PMID: 23503324 BACKGROUND

• Cederholm T, Barazzoni R, Austin P, Ballmer P, Biolo G, Bischoff SC, Compher C, Correia I, Higashiguchi T, Holst M, Jensen GL, Malone A, Muscaritoli M, Nyulasi I, Pirlich M, Rothenberg E, Schindler K, Schneider SM, de van der Schueren MA, Sieber C, Valentini L, Yu JC, Van Gossum A, Singer P. ESPEN guidelines on definitions and terminology of clinical nutrition. Clin Nutr. 2017 Feb;36(1):49-64. doi: 10.1016/j.clnu.2016.09.004. Epub 2016 Sep 14.

  PMID: 27642056 BACKGROUND

MeSH Terms

Conditions

Pneumonia, Aspiration

Condition Hierarchy (Ancestors)

Pneumonia; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jerry Dang, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 5, 2024
• Study Start: February 27, 2025
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)