Treatment outcome of Gastric Peroral Endoscopic Pyloromyotomy in comparison with Percutaneous Endoscopic Gastrostomy with Jejunal extension in medically refractory gastroparesis: a prospective randomized controlled trial.

Gastroparesis (GP) is a gastric motility disorder consisting of upper abdominal
complaints and delayed gastric emptying where mechanical obstruction is
excluded. It is a multifactorial disease with a high severity of impairment and
the complete pathophysiology is not fully understood. Gastric hypomotility and
an increased pyloric tone are mentioned as important underlying mechanisms. In
the MUMC+, tertiary referral centre for GP patients, treatment is based on a
stepwise approach starting with dietary advices, prokinetics and in some cases
tube feeding for three months (gastric rest) in case of decompensated GP. When
reintroduction of oral intake fails, long-term nutritional support is offered
by placement of a percutaneous endoscopic gastrostomy with jejunal extension
(PEG-J). PEG-J is a well-established therapy for gastroparesis. An advantage of
this PEG-J is that adequate intake is guaranteed. Disadvantages are that
patients have a tube through the abdominal wall and oral intake cannot be
resumed. Especially, for the latter reason there is a need for a technique in
which the oral intake can be resumed immediately. Recent literature showed
promising results for the gastric peroral endoscopic pyloromyotomy (G-POEM).
This is a new pylorus-directed minimally invasive therapy consisting of purely
endoscopic myotomy. Studies showed a treatment success of 71% and 77% after six
months and 48 months of follow-up, respectively. Lowering the pyloric tone
should improve the passage of food. This treatment can therefore lead to a
resumption of intake immediately after intervention. Considering the promising
results and benefits regarding resumption of intake, opportunities are seen for
standard treatment in refractory GP patients in order to circumvent the
disadvantages of a PEG-J.

Primary objective:
To investigate the treatment success using the GCSI-score in patients with
refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t = 6
months.

Secondary objectives:
1. To investigate the treatment success using the GCSI-score in patients with
refractory GP undergoing G-POEM compared to patients receiving a PEG-J at t=12
months.
2. To assess the quality of life using the PAGI-QOL in the G-POEM group in
comparison with the PEG-J intervention group.
3. To measure frequency and severity of (s)AEs in the treatment groups.
4. To evaluate whether the etiology of GP can be predictive of treatment
success after G-POEM.
5. To evaluate whether the etiology of GP can be predictive of treatment
success after PEG-J.
6. To identify predictors of short- and long-term G-POEM success (defined as at
least one point decrease in the GCSI-score at 6 months) measured by the Gastric
Alimetry system.

Sensitivity analysis:
1. To investigate the treatment success using the modified GCSI (exclusion of
questions 5 and 6) in patients with refractory GP undergoing G-POEM compared to
patients receiving a PEG-J at t = 6 months.

A randomized non-blinded controlled clinical trial with two study arms (G-POEM
and PEG-J). Treatment success is measured using the GCSI at baseline before
intervention and six months after intervention with a possible cross-over after
six months of follow-up.

Group 1 will receive G-POEM treatment and group 2 will receive PEG-J treatment.

This study does not involve any incapacitated or minority groups and is
considered a low-risk study.
Both study groups will benefit equally by participating in this study. Both
treatments have there own advantages and disadvantages. An advantage of the
PEG-J procedure is that nutritional status can be immediately controlled and it
is a minimal invasive therapy. A disadvantage is that patients can not resume
oral intake after treatment. A risk of the therapy is infection, perforation or
displacement of the tube which requires repositioning or replacement.
An advantage of the G-POEM procedure is that it is a minimal invasive therapy
and it is possible to resume oral intake immediately after treatment. A risk of
the therapy is that perforation can occur or rectal bleeding.
The cross-over design gives every participant the opportunity to receive the
treatment they not primarily got. At the end of the study all participants
benefit equally.

In terms of burden, participation is nearly identical for both groups as they
complete the same questionnaires at the same intervals. Given the nature and
time investment required to complete these questionnaires, this is considered
non-burdensome. In case of the G-POEM intervention, an additional time
investment of 4.5 hours will be required for the Gastric Alimetry measurement.
However, efforts will be made to combine this with other hospital appointments.

In conclusion, the risks associated with participation in the study are
proportional to the benefits that subjects may experience.