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Single arm study to test the feasibility of a new device - the OPTIC imaging probe. All participants enrolled in the study may be imaged using optical spectral reflectance and autofluorescence imaging during their endoscopy procedure.

When a suitable area of tissue is identified by the clinician during a patient's colonoscopy (e.g., a polyp), the imaging probe is inserted into the colonoscope so that it can view the tissue. Optical spectral reflectance and autofluorescence imaging is then performed to collect white light reflected by, and fluorescent light emitted from, the tissue. This is then analysed by hardware and software components in the external analysis unit.

Optical spectral reflectance and autofluorescence imaging

Julian P Teare, MD FRCP

Small growths detected in the colon (polyps) during a colonoscopy may or may not have the potential to develop into cancer. However, since visual inspection alone cannot separate all potentially harmful polyps from harmless ones, the standard approach is to remove them all for histological lab examination, exposing patients to risk of injury and putting a significant demand on hospital resources. An accurate method of determining polyp type during endoscopy would enable the clinician to only remove potentially harmful polyps. A new endoscopic optical imaging probe (OPTIC), which analyses how light interacts with tissue, is proposed to do this. The probe is contained within a normal endoscope and uses white light and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light emitted, along with normal colour pictures of the polyp surface, are measured and recorded to quantify specific characteristics of each type. Optical measurements of polyps detected in endoscopy clinics at Imperial College Healthcare NHS Trust will be analysed to determine if the signal can be used to differentiate different polyp types.

Polyps detected during a colonoscopy may range from benign to precancerous and cancerous. While experienced endoscopists can reliably recognise cancer, the difference between small polyps that have the potential to develop into cancer (adenomas) and those that do not (hyperplastic), is often ambiguous. The standard approach is to simply remove all polyps and analyse them in the histology lab. This means that many patients with hyperplastic polyps (40% of those detected) are unnecessarily exposed to risk of injury (bowel perforation and bleeding) during removal. Furthermore the NHS faces the significant cost of diagnosing this harmless colon tissue. If clinicians were able to accurately determine polyp type during endoscopy, without removal, then hyperplastic tissue could be left alone while potentially harmful tissue is removed.

A pilot study of a new endoscopic optical imaging probe (OPTIC), which analyses how different colours of light interact with tissue, is proposed. Previous research has indicated that these properties differ in hyperplastic and adenomatous polyps. The probe is contained within a normal endoscope and uses white light and blue/violet laser light to illuminate the tissue. The reflected and fluorescent light emitted, along with normal colour pictures of the polyp surface, are measured and recorded to quantify specific characteristics of each type.

Patients attending endoscopy clinics at Imperial College Healthcare NHS Trust will be asked to allow the use of the OPTIC probe during their colonoscopy. If the clinician detects a polyp that he/she intends to remove then this will be analysed using OPTIC before removal. The histology results from the tissue sample will be recorded and correlated to the OPTIC probe measurements. The resulting library of optical data will be used to design software to automatically categorise unknown polyps based on the OPTIC signal. The accuracy of the technique will be compared to the clinicians' visual assessments. The patients' involvement in the study ceases after the colonoscopy.

Optical Polyp Testing for In Vivo Classification

Only anonymised data will be shared. The research team may share findings from the study with non-Imperial College academic collaborators, who will further develop aspects of its imaging capabilities.

Correlation of optical signals from colonic polyps and their histologically-confirmed diagnosis. Quantification of sensitivity, specificity, negative predictive value.

Sensitivity and specificity of measured optical signals in differentiating different grades of adenoma.

Is bowel preparation quality sufficient for endoscopy to proceed? Bowel preparation for some patients may be imperfect and hamper collection of optical data. A measure of the quality and hence, reliability, of the measured data must be obtained for future reference in order to prevent erroneous readings.

An estimate of the time added to an endoscopic examination of the colon due to the need to insert and remove the OPTIC probe

Imperial College London

Herbal and Botanical

All Drugs and Chemicals

Cola

Implementation standardised laparoscopic right hemicolectomy with proctoring

Implementation standardised laparoscopic right hemicolectomy without proctoring

Alexander A.J. Grüter, MD

Usha K. Coblijn, MD, PhD

Jurriaan B. Tuynman, MD, PhD

Pieter J. Tanis, MD, PhD, Prof

Boudewijn R. Toorenvliet, MD, PhD

A surgical intervention might be highly variable amongst surgeons and centers. This variability has a potential relevance concerning clinical outcomes.

For right-sided colon cancer, the laparoscopic right hemicolectomy (LRHC) knows substantial variation. Especially since the surgical technique has been evolving during the latest decade with the introduction of intracorporeal anastomosis, a dissection technique within the correct embryological planes (complete mesocolic excision) and central vascular ligation of the segmental branches at its origin, resulting in an optimal lymph node dissection.

Given the insights from recent studies showing the association between quality of surgery and relevant clinical outcomes, there is a great need for a formative quality assessment of LRHC. Detailed objective assessment of the LRHC is currently not performed in clinical practice nor in surgical training. Quality assessment of LRHC has great potential to improve surgical training and furthermore, implementation of a standardized technique will ultimately lead to better quality of care for patients suffering from right-sided colon cancer.

The main objective of this study is to improve surgical outcomes for patient with right-sided colon cancer by a prospective sequential interventional cohort study that aims to standardize the surgical technique with subsequent controlled implementation after standardized review of the current practice in a nationwide multicenter setting. The primary endpoint is the 30-day morbidity according to the Clavien-Dindo classification system.

1. Prospective mapping of current practice with surgical variations in laparoscopic right hemicolectomy (total duration of inclusion 3 months) N= 40 centers N = 310 videos

   1. METC approval for the use of anonymized videos of a laparoscopic procedure and collection of corresponding clinical outcomes.
   2. Approaching hospitals for participation (high volume centers (50+ colon cancers).
   3. Prospective inclusion of consecutive patients undergoing laparoscopic right hemicolectomy in the participating hospitals in three months.
2. Development of Standard Laparoscopic Right Hemicolectomy: an (inter)national Delphi study

   1. Approaching specialists to participate in the Delphi method (from participating hospitals in step 1).
   2. Identification of crucial steps and measures according to literature and expert's opinion (Delphi method).
   3. Documentation of steps and the order in which they need to be performed, development of a competency assessment tool (CAT).
3. Skills center training facility

   a. Training the participating surgeons in the method of the standardized laparoscopic right hemicolectomy, as consented in the Delphi method.
4. Implementation of the standardized laparoscopic right hemicolectomy with proctoring during another period with prospective inclusion of consecutive patients with collection of surgical videos in all participating hospitals (N=40 centers, total 310 videos)

   1. Rating videos.
   2. Comparing with pre-implementation performance based on outcome measures reflecting oncological quality of surgery, and 30-day clinical outcomes.
   3. Comparing with pre-implementation performance based on the long-term outcomes. (3-year DFS and 5-year OS).
5. Implementing standardised lap right hemicolectomy (after learning curve without proctoring)

   1. Consecutive inclusion of patients (n=310)
   2. CT imaging
   3. Video analysis
   4. Competency analysis
   5. Variation analysis
   6. Clinico pathological data

A prospective interventional sequential cohort study with a transition period

Standardizing Right Hemicolectomy for Colon Cancer

Implementation of Optimized and Standardized Surgical Technique for Right Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study With a Transition Period

Assessment according to a competency assessment tool (CAT) for laparoscopic right hemicolectomy. This tool will be created during phase 2 using the Delphi method.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Optical Polyp Testing for In Vivo Classification	NCT03139942	Colonic Polyp Colonic Disease... Colonic Neoplas... Colonic Adenoma Colonic Adenoca... Colonic Dysplas... Colonic Carcino... Colonic Cancer Colon Hyperplas...	Optical spectra...	18 Years -	Imperial College London
Standardizing Right Hemicolectomy for Colon Cancer	NCT04889456	Colonic Carcino... Laparoscopic Ri... Standardisation Training Delphi Study Implementation Consolidation Assessment	Implementation ... Implementation ...	18 Years -	Amsterdam UMC, location VUmc

Spots Global Cancer Trial Database for colonic carcinoma