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SPECC Lecture Duxford 12th July 2017

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SPECC - Significant Polyp and Early Colorectal Cancer:
To advance local and regional practice in the definition, recognition, documentation, treatment and strategic planning for significant polyps and early colorectal cancer

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SPECC Lecture Duxford 12th July 2017

  1. 1. www.profginabrown.com @prof_gina_brown Should MRI be used to stage SPECC rectal lesions?
  2. 2. • 1994 • Endorectal coil tested for staging of 12 rectal cancers • High resolution T2 • T2-weighted FSE Sequence (4,000/100, 256 x 256 matrix, echo train length of 16). All images were obtained with an 80-120-mm field of view and 3-mm-thick sections with no gap. • Pixel size =120/256 = 0.46mm x 0.46mm
  3. 3. High resolution MRI Without endorectal coil Pixel size 0.6 x 0.6mm
  4. 4. Technique Essential Checklist • Scan duration = quality • 4-6 NSA/NEX and T2- FSE / TSE • 0.6mm x 0.6mm x 3mm = 1.1mm3 voxel • Adequate coverage – 5cm above top of tumour • Perpendicular to the rectal wall • Low rectal cancer – parallel to anal canal • Ensure discontinuous deposits are covered on high res • Buscopan • Saturation Bands • firm coil placement with secure strapping
  5. 5. With Saturation band and buscopan Without Saturation band
  6. 6. The submucosal fold pattern
  7. 7. ERC subclassification • T0/early T1sm1 – no evident disruption of the submucosa – entire thickness of SM appears preserved • T1sm2 – at least 1mm of submucosa is preserved • T1sm3/early T2: full thickness of muscularis propria is preserved but <1mm submucosa is visible • T2 early >1mm muscularis is preserved • T2/T3a – 0mm of muscularis preserved microscopic invasion beyond muscularis <1mm – prognosis identical for this subgroup • T3b 1-5mm – good prognosis
  8. 8. • 68 yo female • Rectal bleeding, colonscopy malignant 2cm adenocarcinoma (biopsy proven) mass in lower rectum • Performance status 1, no comorbidities
  9. 9. 1. APE/ELAPE 2. Ultralow TME 3. Local excision 4. Full thickness TEM 5. Preop Rx
  10. 10. 1. APE/ELAPE 2. Ultralow TME 3. Local excision 4. Full thickness TEM 5. Preop Rx Morphology – flat semi-annular Diameter 16mm Thickness of lesion : 7mm Clockface location of central depression =4 oclock Invasive edge = 5mm diameter Muscularis fully preserved Submucosa/muscle interface lost over 3mm distance on single slice at 4 o’clock Lymph nodes show smooth nodal capsule and no heterogeneity - benign Assess height of 6.5 cm above anal verge and 12mm above puborectalis sling No extramural venous invasion T1sm3/ with potential focal early T2 invasion on a single slice section
  11. 11. Final pathology • CLINICAL SUMMARY TEMS-anorectal polypoid lesion • HISTOLOGY The referred sections are of colonic mucosa with a tubulovillous adenoma having both highly and low-grade dysplasia, with an area of moderately to poorly differentiated adenocarcinoma with desmoplasia, tumour budding and focal mucinous differentiation. Invasive tumour area measures 13 x 5.5 mm and just involve the innermost fibres of the muscularis propria. There is lymphatic vascular invasion and focal submucosal venous angioinvasion. In therefore constitutes a higher risk lesion, although the nearest deep excisional or marginal clearance is 3.5 mm. Further deeper sections do not reveal any deeper invasion. • pT2 NX MX LVI+ R0
  12. 12. I/12 after TEM 3/12 after TEM
  13. 13. 4 years post Surveillance • She has been extremely well since her last review in the clinic. She is able to manage a normal diet and her weight is stable. • She refers to mild incontinence for gas and stool but denies any blood or mucous in the stool. • On examination today, the abdomen was soft, non tender. There was no palpable lymphadenopathy. On PR examination, the sphincter tone was mild. There was no palpable mass in the rectum. • There was no blood or stool on the gloved examination finger. The CEA on the 11th February was 3 and the CA19-9 was 3. • The last MRI showed no evidence of recurrent disease.
  14. 14. Post TEM surveillance of mesorectum
  15. 15. Local excision scar
  16. 16. 28/34 had 1 or more high risk features 22/24 patients with low tumours and high risk features which would have required APER have so far avoided radical surgery and remain disease free at a median follow up 3.2 years. Lesions identified on MRI – roadmap for TEM/TAMIS: LE Assess mesorectum and TEM planes Review histology Counsel patients: completion TME surgery versus adjuvant CRT and surveillance
  17. 17. Recommended reporting structure for staging early rectal cancer using MRI • State morphology – flat, polypoidal, mucin containing • Measure diameter and thickness of lesion • If polypoidal –state site and diameter of fibromuscular stalk • If flat – quadrant or clockface location of central depression versus raised rolled edges • Measure extent/diameter of invasive border • Assess degree of preservation of the mucosa, submucosa, muscularis propria layers at the stalk • Assess lymph nodes for malignant characteristics based on nodal capsule breach or heterogeneity of signal • Assess height of lesion in relation to anal verge and puborectalis sling • Evaluate extramural veins for discontinuous spread
  18. 18. 19 PRE-therapeutic MRI assessment of Early StagE Rectal Cancer and significant Rectal Polyps to aVoid major resectional surgery: A new approach to the management of Early stage rectal cancer MRI-PRESERVE/MINSTREL Current Investigators and Collaborators Professor Gina Brown Professor Wendy Atkin Mr Chris Cunningham Professor Robert Goldin Mr Greg Wynne Dr Monica Terlizzo Mr Shahnawaz Rasheed Mr James Kinross Mr Ian Swift Ms Karen Thomas Ms Annabel Shaw (Croydon Res Fellow)
  19. 19. The Royal Marsden MRI-PRESERVE 3rd May 201720 Background – Increase in detection rates of early rectal cancer (ERC) through bowel cancer screening programme (BCSP) – >10% of positive FOBT diagnosed with malignancy – ~ 30% rectal cancer – ~ 30% limited to bowel wall without nodal spread
  20. 20. The Royal Marsden Current problem Current pathway following diagnosis of polyp / polyp cancer does not involve pre-op staging Cancer polyps that are removed endoscopically are mostly subjected to TME surgery afterwards At present, 90% of stage I cancers undergo major resectional surgery when detected by bowel screening MRI-PRESERVE 3rd May 201721
  21. 21. The Royal Marsden MRI-PRESERVE 3rd May 201722 65 patients undergoing primary surgery/local excision for mrT3b or less tumours MRI accuracy for <T1sm2 =89%(95%Cl:63-87%) PPV 77%, NPV 92% MRI accuracy <T2 89% (95%Cl:79%-95%), PPV 93%, NPV 81% Kappa score 0.7 for radiologists (GB and SB) 21/65(32%) patients underwent local excision or TEM 20/21 were staged as MR<T2 and confirmed as such by pathology. On follow up, none had relapse.
  22. 22. The Royal Marsden MRI staged patients <T2 undergoing radical surgery 22/44 were <mrT2. MRI accuracy in predicting lymph node status was 84%(95%Cl:70%-92%), PPV 71% and NPV 90% If the decision had been made to offer local excision on MRI TN staging rather than clinical assessment a significant increase in organ preservation surgery from 32% to 60% would have been observed (difference 23%, 95%Cl:9%-35%) MRI-PRESERVE 3rd May 201723
  23. 23. The Royal Marsden Future goal To improve organ preservation rates in screen detected / symptomatic colonoscopy identified ERC by incorporating MRI into the staging pathway MRI-PRESERVE 3rd May 201724
  24. 24. The Royal Marsden MRI Staging - MINSTREL New MRI staging system Four surgical planes • Mucosal – endoscopic mucosal excision (EMR) • Submucosal – endoscopic submucosal resection / partial thickness transanal endoscopic microsurgery (TEMS) • Deep submucosal / muscle invasion – full thickness TEMS • Deep muscle / extramural disease – full oncological resection Increase in organ preservation by at least 10% High-resolution MRI as a method to predict potentially safe surgical planes in early rectal cancer patients Balyasnikova S et al. MRI-PRESERVE 3rd May 201725
  25. 25. The Royal Marsden MRI-allocated surgical planes MRI-PRESERVE 3rd May 201726 A Mucosal EMR (mucosal) resection could clear deep margin No definite SM (submucosal) invasion B Submucosal Endoscopic Sub-mucosal Resection / partial thickness TEMS Definite SM invasion seen but <1mm SM >1mm SM invasion seen but >1mm SM preserved to MP C Deep submucosal / early muscle invasion Full thickness TEMS SM invasion seen, <1mm if SM preserved but no definite muscle invasion Definite muscle invasion seen but greater than 1mm muscle preserved to mesorectum D Deep muscle or extramural disease full oncological resection required Less that 1mm of muscle preserved but no mesorectal invasion Definite invasion of mesorectum
  26. 26. The Royal Marsden Minstrel A – mucosal EMR (mucosal) resection could clear deep margin T1 sm0/1 MRI-PRESERVE 3rd May 201727
  27. 27. The Royal Marsden MRI-PRESERVE 3rd May 201728 Minstrel B – submucosal Endoscopic Sub-mucosal Resection / partial thickness TEMS T1 sm2/3
  28. 28. The Royal Marsden MRI-PRESERVE 3rd May 201729 Minstrel C – deep submucosal / muscle invasion Full thickness TEM T1 sm 3
  29. 29. The Royal Marsden MRI MINSTREL-PRESERVE Feasibility phase to confirm diagnostic accuracy in predicting feasibility of TEM/local excision plane Multi-centre interventional trial – PRESERVE Trial End points: >10% 5 year organ preservation rate in screen-detected T1 / early T2 rectal cancers >80% disease-free survival / overall survival Radiologists have been trained in the new MRI staging system for early rectal cancer (as investigated in the Minstrel Study) MRI-PRESERVE 3rd May 201730
  30. 30. The Royal Marsden Primary objectives to increase rates of successful local excision of early rectal cancers MRI-PRESERVE 3rd May 201731 Secondary objectives • to improve MRI radiological staging of ERC, and increase ability for surgical resection plane planning based upon initial imaging • to train radiologists in the use of the new reporting system, and demonstrate good agreement with the correct surgical plane • to improve local excision techniques – (R0 resection) through integration of improved pre-operative imaging protocols with real time tissue phenotyping technologies - i-Knife • embedding new technologies developed at Imperial into mainstream surgical practice for improved therapy of ERC • identifying biological phenotypes that predict good outcomes following local excision
  31. 31. The Royal Marsden Control Comparison surgical management according to conventional MDT decisions, clinical assessment, and standard MRI reporting protocols – contemparaneous matched data to be obtained from Public Health England MRI-PRESERVE 3rd May 201732 Intervention Surgical decision determined by extent of deep margin and absence of EMVI /obvious malignant nodes/ discontinuous deposits • Mucosal - endoscopic mucosal excision (EMR) • Submucosal – endoscopic submucosal resection / partial thickness TEMS • Deep submucosal / early muscle invasion – full thickness TEMS • Deep muscle / extramural disease – full oncological resection
  32. 32. The Royal Marsden Inclusion / Exclusion Criteria Inclusion • Rectal polyps >2cm in diameter • Suspected malignant rectal polyp • Biopsy proven rectal malignancy Exclusion • Patients requiring neoadjuvant therapy • Metastatic disease • Synchronous malignancy • Contraindications to MRI MRI-PRESERVE 3rd May 201733
  33. 33. The Royal Marsden Statistical recommendations Simon two-stage optimal design First stage • Total of 30 patients • Success in at least 4/30 in order to proceed • Success defined as organ preservation with R0 Second stage • Total sample size of 89 • Success in at least 14/89 for trial to reach positive conclusion • success will be defined from longer follow-up, including disease-free survival, overall survival and overall stoma-free survival MRI-PRESERVE 3rd May 201734
  34. 34. The Royal Marsden MRI-PRESERVE 3rd May 201735 Trial Flowchart
  35. 35. The Royal Marsden Outcomes for patients This will all result in improvements in the management of patients with ERC Cost benefit • Reduction of TME major resections • Increased organ-preservation rates • Reduced length of hospital stay / perioperative complications Improved quality of life • Reduced side effect / complication profile for all patients • Limit the surgical intervention for otherwise well asymptomatic screening patients /symptomatic patients MRI-PRESERVE 3rd May 201736
  36. 36. The Royal Marsden37 MINSTREL – Superficial / SM plane/ Full thickness
  37. 37. • Radiologists at recruting sites are trained and hold delegated responsibility • Eligible patients are identified on colonoscopy if they are found to have a 20mm to 50mm rectal tumour within 150mm of the anal verge (consent and completion of endoscopy CRF) • All patients who enter the trial will be sent for an MRI. The MRI will be reported using the novel staging proforma (radiology CRF) • The patients will proceed to excision or resection of the tumour as per clinician / MDT discussion. (MDT CRF) • The appropriateness of preoperative stage will be compared against histopathology gold standard (Pathology CRF)
  38. 38. The Royal Marsden39
  39. 39. The Royal Marsden Recruitment When is the optimal time for surgery after completion of CRT? 13/3/201440

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