Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03420729 |
| Other study ID # |
STH19595 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 7, 2017 |
| Est. completion date |
September 1, 2020 |
Study information
| Verified date |
April 2024 |
| Source |
Sheffield Teaching Hospitals NHS Foundation Trust |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Dyspepsia is a common presenting complaint that doctors have to manage and this is true both
in the primary and secondary care setting. OGD is a useful test for investigating a variety
of suspected upper GI disorders including dyspepsia. However, it is uncomfortable for
patients and incurs the risk of intubation and sedation. Capsule endoscopy (CE) is the
investigation of choice for diseases of the small bowel. It is safe, non-invasive and well
tolerated, the main risk being capsule retention occurring in up to 1-2% of procedures.
The investigators wish to undertake a prospective study comparing acceptability and
tolerability of MACE and OGD in the investigation of dyspepsia. Patients presenting to
general practice or the outpatients department with symptoms of dyspepsia who are referred
for investigation are invited to take part in the study. Patients will undergo MACE prior to
OGD performed by an endoscopist blinded to the MACE findings. . A comparison of tolerance and
acceptance of both procedures will be measured by means of using structured and validated,
qualitative questionnaires. The aim is to assess for whether there is a significant
difference between the perception and experience of both modalities.
Description:
This is a prospective, single blinded, comparative trial of patient acceptability and
tolerability of MACE and both transoral and transnasal gastroscopy in the investigation of
dyspepsia.
The study will be conducted within Sheffield Teaching Hospitals. Recruitment will take place
at the Sloan Medical Centre, the Royal Hallamshire Hospital or the Northern General Hospital
during the consultation when patients present with dyspepsia requiring gastroscopy for
investigation as per national guidelines. MACE will take place at the Sloan Medical Centre.
Equipment for collecting demographics (height, weight etc) will be available. All the capsule
equipment is stored and re-charged in this designated room. The case report files and
computer data will be stored in this room that is secured by a locked door.
Gastroscopy will take place in the Endoscopy Departments, which are specially designed units
for a variety of endoscopic tests, at the Royal Hallamshire Hospital and Northern General
Hospital.
Patients are assessed in the Sloan Medical Centre or the Royal Hallamshire Hospital/Northern
General Hospital outpatients department for their primary presenting complaints of dyspepsia.
The study will be discussed with patients in those who satisfy the enrolment criteria and
they will be provided by with the written study literature. If in agreement to enter the
study, informed written consent will be obtained from the patient.
Prior to any investigation, the pre-MACE section of the questionnaire will be completed by
the patient with the assistance of study team members. MACE will be performed at the Sloan
Medical Centre; this will be in a dedicated room setup to accommodate the MACE procedure.The
post-MACE section of the questionnaire will then be completed by the patient with the
assistance of study team members. MACE will be preceded by obtaining measurements of height,
weight and waist/hip circumference. The patient will then be given 500 to 1000mls of water
with 6 drops of simethicone added to drink. This is to enable adequate distension of the
stomach. Our previous study has shown excellent tolerance of this volume of water distension
by patient.
The patient then swallows the capsule in the presence of the PI. MACE of the oesophagus and
stomach will be carried out by the PI. Once the PI is satisfied that an adequate examination
has been completed the capsule will be allowed to pass into and through the small bowel.
Visibility of major locations of the stomach will be documented. Any pathology noted will be
recorded according to the standard fashion described for gastroscopy reporting. A note of the
procedure duration will be recorded. The patient will be given the option to complete their
small bowel capsule endoscopy in the standard way and this will be reported in the usual
fashion.
Patients referred for gastroscopy as part of the normal pathway for investigation of
dyspepsia, will attend a designated list for their gastroscopy within 1 week and this will be
performed by a JAG accredited endoscopist who has experience in endoscopic therapy. TOG will
be performed using a standard 11mm Olympus or Pentax gastroscope and TNG will be performed
using an ultra-thin 5.9mm Olympus or Fujinon gastroscope. The endoscopist performing the
gastroscopy will be a member of the study team. The participant will be asked to complete the
pre-gastroscopy section of the participant questionnaire before, and the post-gastroscopy
section after the procedure.
Patients will have 80mg simethicone mixed in 100mls of water as an anti-foaming agent prior
to the gastroscopy. Patients undergoing TNG will have their nasal passages prepared with a
fine mist of 5% lidocaine and 0.5% phenylephrine (co-phenylephrine nasal spray) which are a
local anaesthetic and nasal decongestant. Phenylephrine is a topical vasoconstrictor used as
a nasal decongestant to reduce the risk of peri-procedure epistaxis. Five minutes following
this, a 6mm diameter soft-sillicone catheter lubricated with 2% aqueous lidocaine gel is
inserted into either or each nasal passage approximately 5-8cm passages to ensure the passage
is wide enough to comfortably accommodate a nasal endoscopy. If neither passages accommodate
the silicone catheter, the procedure will be converted to a transoral route. Patients
undergoing TOG will have 10 sprays of 10% topical lidocaine administered to the oropharynx.
Procedures will be performed in the left lateral decubitus position.
Gastroscopy will be performed in the standard fashion and reported to the PI to compose a
written record for study purposes. This reporting system (InfoFlex) requires details to be
entered regarding indication for examination, patient comfort, sedation and pathology.
Pathology will be documented in a standardised way (for further details see section on
Scientific Justification). An entry of the duration of procedure will be included. This
denotes the end of the participants' involvement in the study. The patient will be managed
thereafter according to the responsible clinician at the Sloan Medical Centre or Sheffield
Teaching Hospitals NHS Trust.
The primary outcome will be evaluated using the questionnaires to compare acceptability and
tolerance of both procedures.
