ABSTRACT: Interventions: This is a research study looking to better understand how a specific portion of the colon functions. The aim of the study is to see how the colon situated in the left upper quarter of the abdomen, near the spleen (i.e., splenic flexure), manages to drain its tissue fluid (i.e., lymph). So far, lymphatic drainage of this part of the colon remains incompletely understood.
The study is being conducted within the Department of Colorectal Surgery at Concord Hospital, Sydney Local Health District (SLHD) by Dr Krishanth Naidu, under the supervision of A/Prof Matthew Rickard, A/Prof Robert Russo and Dr Kheng-Seong Ng.
A Participant Information Sheet (PIS) will inform participants about what is involved in the study and help them decide whether they wish to take part.
2.Study Procedures
The study procedure will take place within the Concord Repatriation General Hospital. Participants will be included into the study only if they have a normal colonoscopy.
During the test
Part 1
Once a normal colonoscopy is performed (standard of care), the area of interest (i.e., splenic flexure) is explored (research component). A special tracer (described below) is placed using the scope to trace the lymphatics.
Part 2
Single photon-emission computed tomography (SPECT) is a test that uses a special type of camera and a tracer (a radioactive substance in liquid form) to look at organs in the body. With this study, the tracer is injected into a small portion of the participant s colon that we are interested in (close to the spleen) to trace the lymph flow of the region. After that, in the Nuclear Medicine Department, a special camera records where the tracer has moved to. As part of the SPECT, participants are required to lie still in a scanner fo
Primary outcome(s): Safety profile of in vivo, endoscopically placed submucosal radio-nuclide tracer, with subsequent scintigraphy mapping using SPECT-CT technology with understanding and recording of adverse reaction profile and rate. This will be assess using a study specific questionnaire via a telephone call. A clinical examination will be undertaken if clinically warranted.
Examples of known/possible adverse events include but not limited to:
1.SPECT-CT related
a.Claustrophobia in individuals with a history of anxiety in closed spaces
b.This research study involves exposure to a small amount of radiation. As part of everyday living, everyone is exposed to naturally occurring background radiation and receives a dose of about 2 millisieverts (mSv) each year. The effective dose from this study is about 3mSv and is markedly less than a multiphase CT abdomen and pelvis (~30mSv), which is regularly requested in the hospital and community setting. At the dose level used in our study, no harmful effects of radiation have been demonstrated as any effect is too small to measure. The radiation related risk is believed to be low and theoretically is less than 1 in 1000.
c.Reaction to contrast is rare but may involve:
i.Allergic reaction (e.g., rash, wheeze, difficulty breathing, fever, chest pain)
d.Per-rectal bleeding from submucosal injection
2.Colonoscopy related
a.Hole in bowel (Perforation)
i.Less than 1 in 1000 risk
b.Increased anaesthetic time
i.Slightly longer sedation time (Not expected to affect recovery time and discharge)
c.Placement of clip
i.Too deep (very rare) – causing perforation
ii.Bleeding (rare)
iii.Clip falls off
d.Pain
e.Tracer placed in an unintended layer of bowel (too deep or too shallow)[24hours, 7 days and 30 days following radio tracer injection and SPECT CT acquisition];Feasibility of using an endoscopically placed submucosal radio-nuclide tracer, with subsequent scintigraphy mapping using SPECT-CT technology. This will be assessed by examining or confirming:
1. Time taken for research phase of colonoscopy (using the intubation timer that is built in to the endoscopy operating system)
2. Submucosal instillation of the radio tracer with minimal to no spillage intraluminally (via visual inspection by researcher and confirmation on subsequent SPECT CT imaging.
3. Participant recruitment and attrition rate (via an audit of study enrolment/withdrawal logs)
4. Protocol retention rate (via an audit of study protocol diary logs)
5. Time to SPECT CT after recovery from endoscopy procedure ( via a digital stopwatch)
All measures will be assessed together as a composite primary outcome.[From recruitment date to day-30 following research phase of colonoscopy, instillation of radio tracer and subsequent SPECT-CT. This thus encompasses the recruitment phase, research colonoscopy phase, SPECT-CT phase and follow up phase (Day 1, Day 7 and Day 30 phone calls).]
Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Type of endpoint: Safety/efficacy
