Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04151030 |
| Other study ID # |
01049 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 28, 2019 |
| Est. completion date |
July 1, 2021 |
Study information
| Verified date |
August 2021 |
| Source |
Kansas City Veteran Affairs Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Placement of a feeding tube through a gastrostomy can be performed endoscopically or
radiologically. While percutaneous endoscopic gastrostomy (PEG) tube placement is most
frequently performed using a "pull" technique, this method may not feasible in patients with
malignant, or tight benign, esophageal stenosis. Further, the "pull" technique may drag tumor
cells with the feeding tube and lead to implantation metastasis at the gastrostomy site. A
clinical practice update by the American Gastroenterological Association has recommended that
the pull-through PEG placement method should be avoided in all patients with oropharyngeal or
esophageal cancer. It also recommends that the introducer/Push PEG method should be favored
instead of the pull PEG. In such situations, an introducer-style, "Direct" gastrostomy tube
can be placed endoscopically or radiologically. However, the published data comparing
outcomes and safety of endoscopic "Direct" PEG (D-PEG) and interventional radiological PEG
(IR-PEG) are very sparse.
The D-PEG is performed under endoscopic visualization of the gastric wall which facilitates
greater control and allows safe selection of gastrostomy site. Further, the presence of an
endoscope enables transillumination to confirm the absence of intervening abdominal viscera
between the abdominal wall and the anterior wall of the stomach. These advantages are lacking
with the IR-PEG. We hypothesize that D-PEG is safer than IR-PEG.
In this single center, non-randomized study, patients unable to undergo a conventional
per-oral "Pull" PEG and needing a D-PEG will be prospectively enrolled. For the comparison
arm, historical IR-PEG procedures at our center will be assessed. The technical success and
rates of adverse events will be compared between the two arms. Approval from the
Institutional review board has been obtained. Based on our experience, we estimate a sample
size of 40 participants in each arm and anticipate completion of this pilot study by June
2021.
Description:
Introduction Percutaneous endoscopic gastrostomy (PEG) tube placement is a frequently
performed procedure to provide enteral nutrition in patients with dysphagia. Two methods are
used for placing a PEG tube via the mouth: The "Pull" method and the "Push" method(1). In the
"Pull" technique, the feeding tube is pulled from the mouth, through the esophagus and
stomach to the outside. In the introducer-style "Direct" technique, the feeding tube is
pushed from the outside to inside the stomach. Both these techniques are considered safe,
effective, and have their own advantages and disadvantages(2).
Limitations of Pull PEG technique The "Pull" PEG technique is challenging in patients with
head and neck malignancies, obstructing esophageal cancers, and laryngeal malignancies. The
severe stenosis often precludes the passage of the adult endoscope as well as the large
internal bumper of the feeding tube which must be pulled through the stenotic upper
gastrointestinal tract. Further, microorganisms and malignant cells from the oropharynx/
esophagus can be pulled by the feeding tube leading to peristomal infections as well as
metastatic deposits at the site of the gastrostomy(3,4). A prospective evaluation of "Pull"
PEGs placed in patients with oropharyngeal and esophageal tumors revealed metastatic deposits
of malignant cells in 9.5% of patients, 16 weeks after the PEG(5). Retrospective assessment
of PEG placement for oropharyngeal cancer demonstrated abdominal wall metastasis of 0.64%(6).
Direct PEG technique The endoscopic Direct PEG (D-PEG) uses the Russel introducer technique
which obviates the passage of the gastrostomy tube through the oropharynx. Further, it can
also be performed with an ultrathin endoscope which is easy to navigate through stenotic or
malignant upper gastrointestinal tract obstructions. The D-PEG requires performance of
gastropexy (attachment of gastric wall to the abdominal wall using sutures) with anchor-like
T-fasteners for easy and safe placement of the PEG tube(2).
The D-PEG is performed under endoscopic visualization of the gastric wall which facilitates
greater control and allows safe selection of gastrostomy site. It also obviates the need for
ionizing radiation. Further, the endoscope enables transillumination to confirm the absence
of intervening abdominal viscera between the abdominal wall and stomach. These advantages are
lacking in IR-guided PEG which does not offer endoscopic visualization of the gastric lumen.
Currently, patients who fail a per-oral Pull PEG tube placement are typically referred for
IR-guided PEG placement(3). Thus, patients who fail a "pull" PEG procedure, are referred to
IR for a second invasive procedure. However, with the availability of the D-PEG, patients
failing a "Pull" PEG can undergo a PEG placement during the index procedure.
Recommendations from GI societies A recently published clinical practice update has
recommended that the pull-through PEG placement method should be avoided in all patients with
oropharyngeal or esophageal cancer, to reduce the risk of implantation metastasis. Further,
the authors recommend that the introducer/Push PEG method should be favored instead of the
pull PEG(7,8).
Hypothesis We hypothesize that the D-PEG is safer than the IR-PEG in patients unable to
undergo a per-oral Pull PEG.
Aims Primary Aim: Comparison of adverse events of D-PEG vs IR-PEG in patients unable to
undergo a Pull PEG Secondary aims: Comparison of technical success and overall procedure
duration between D-PEG and IR-PEG in patients unable to undergo a Pull PEG The data from this
pilot study will be used to design a multi-center prospective randomized trial comparing
outcomes and safety of D-PEG and IR-PEG. The subsequent trial is intended to be performed at
different centers where these procedures are routinely performed, such as Virginia
Commonwealth University, University of Utah, and Baylor College, TX.
Pilot data The investigators have received approval from the institutional review board. We
have performed D-PEG procedure in 13 patients so far with technical success in 12 patients
(92%). There have been no major adverse events including perforation, significant
procedure-related bleeding, or procedure related death. One patient accidentally dislodged
his tube which was replaced without endoscopic intervention (minor adverse event: 1).
Research design This will be a prospective study of participants undergoing D-PEG placement
compared with patients who previously underwent IR-PEG placement.
Endoscopic/prospective arm The patients who fail the endoscopic pull PEG placement, or are
not candidates for a Pull PEG, will undergo an D-PEG procedure at the time of the index
endoscopy. During the pre-procedure consent process, participants will be offered IR-guided
PEG placement as an alternative. This is the standard of care for patients who present to the
endoscopy unit for PEG tube placement. All standard protocols including pre-procedure
assessment, intra-procedure antibiotic use and post procedure protocols will be observed. In
addition to the standard care which all patients receive, the technical success and adverse
event rates will be recorded. Participants will receive a phone call within 1 week, and
within 30 days of the procedure to assess for any post-procedure complications. These data
will be recorded in the medical chart.
The study will be performed at Kansas City VA Medical Center, Kansas City, Missouri. The
procedures will be performed by trained, board-certified gastroenterologists with extensive
experience in placing PEG tubes.
Statistical Analysis/power analysis:
We will compare the technical success of D-PEG versus IR-PEG placement. Technical success is
defined as the successful placement of the D PEG.
Primary outcome (adverse event rate):
We assume 15% complications (bleeding, infection, tube dislodgement, perforation) with
IR-PEGs and 5% complications in D-PEGs. With 80% power to test a noninferiority margin of 5%,
we intend to enroll 50 patients in the prospective arm done by endoscopists and 50 patients
in the retrospective arm done by IR.
Secondary outcome (technical success) We assume a 95% technical success rate on IR guided
push PEG placement. We also assume a 90% technical success rate on endoscopic push PEG
placement. Using a non-inferior to margin of 20%, and an 80% power to test the hypothesis, we
intend to enroll 50 patients in the prospective arm and 50 patients in the retrospective arm.
We will use Student's t-test compare means and chi-square test to compare the two arms. We
will also use multi variate analysis and ANOVA for the analysis of all variables.
Recruitment of subjects
Patients with dysphagia requiring PEG placement will be recruited from the following sites:
Referred to the GI clinic for placement of a gastrostomy tube Referred by the Kansas City VA
tumor board for placement of a gastrostomy tube (e.g. head and neck cancers and esophageal
malignancies) Outpatient or Inpatient GI consults for gastrostomy tube placement Patient's
meeting the inclusion and exclusion criteria listed above will then be assessed by the
principal investigator and offered enrollment into the study.
