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Introduction to CReST

Obstructing colorectal cancer. 8-29% of all colorectal cancers present as emergenciesMortality rates 20-40% (vs 4% for elective surgery)High morbidity and permanent stoma rates. . Presentation and Outcome COLORECTAL CANCER. Mode of % of all In-hospital 5 yrpresentation patien

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Introduction to CReST

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    1. Introduction to CReST Jim Hill

    2. Obstructing colorectal cancer 8-29% of all colorectal cancers present as emergencies Mortality rates 20-40% (vs 4% for elective surgery) High morbidity and permanent stoma rates

    5. Rationale Pre-operative correction and stabilisation of fluid and electrolyte balance Reduction of diaphragmatic splinting and pain with improvement in respiratory function Treatment of medical co-morbid disease Accurate pre-operative staging of the patient Referral to a specialist colorectal surgeon In a few patients with rapidly progressive (advanced) disease or unstable comorbid disease, major surgery may be avoided

    6. Sebastian et al, Am J Gastroenterol 2004 Pooled analysis of 1,198 patients in 54 studies. Median technical and clinical success rates of 94% (i.q.r 90-100) and 91% (i.q.r 84-94). Clinical success when used as a bridge to surgery was 71.7%. Major complications perforation (3.7%), stent migration (11.8%). Stent related mortality 0.58%.

    7. Martinez-Santoz et al, Dis Colon Rectum 2002 Emergency surgery (n=29) Pre-operative stent and elective surgery (n=26) Stenting and elective surgery was associated an increase in the primary anastomosis rate (84.6% vs 41.4%, p=0.0025) a lower need for a colostomy (15.4% vs 58.6%) a significantly reduced hospital stay (14.23 vs 18.52 days and intensive care unit stay (0.3 vs 2.9 days) a reduction in the number of patients with severe complications (11.6 vs 41.2%).

    8. Dutch Stent-in-one trial The only randomised controlled, the Dutch Stent-in 1 study, was stopped by their safety monitoring committee and the reasons for this reported this year in the Lancet. This was a multi-centre, prospective controlled trial designed to asses the potential benefit of endoluminal stenting compared to surgery in patients with incurable colorectal cancer. The trial was stopped prematurely because of the high rate (4/10) of stent related complication. The authors were unsure whether the unexpectedly high complication rate was attributable to the design of the new stent being tested or a chance phenomenon.

    10. Questions Can preoperative stenting of obstructing left-sided colo-rectal cancers enable improved preparation and staging of the patient? Can the surgical outcome be significantly improved by converting an emergency into an elective procedure Is there a reduced risk of stoma formation? Is there an improvement in Quality of Life? Are post operative complications reduced? Is survival increased?

    11. End Points Primary: 1. 30 day mortality 2. Length of hospital stay 3. Presence and duration of a stoma Secondary: a) Stenting completion and complication rate (arm A) b) Anastomosis rate c) Quality of life (EQ 5D and EORTC QLQ-CR 29) d) Overall survival e) Disease-free survival at three years (attempted curative surgery group only) f) Length of stay on ITU or HDU g) In-hospital morbidity h) Cost benefit analysis i) Rate of adjuvant chemotherapy (stage II and stage III cancer) and adherence to chosen chemotherapy protocols

    12. Exclusion criteria Patients with signs of peritonitis and/or perforation Patients with right iliac fossa tenderness & features of incipient caecal perforation Patients with obstruction in the rectum, that may require neoadjuvant therapy (i.e. tumours in the mid or lower rectum) Patients who are unfit for surgical treatments or refuse surgical treatment. Patients who are unwilling to consent to participate Pregnant patients

    14. Potential adverse outcomes 1) Failure to deploy stent 2) Bowel perforation 3) Tumour dissemination 4) Hospital stay and cost

    15. Statistical Power 400 patients will be randomized over three years from 20 centres in the UK and selected centres overseas The feasible study size would be adequate to detect a 50% reduction in 30-day mortality with stenting and elective surgery compared to primary anastomosis (e.g. 13% vs 27% as reported in audit data) 90% power to detect a reduction in operative complications from 40% to 25% - Martinez-Santoz et al reported a reduction from 41% to 12% in their non-randomised study).

    16. Statistical Power 90% power to detect a 0.35sd reduction in days in hospital equivalent to 1-2 days. It is not anticipated that there will be any significant loss to follow-up. 90% power to detect differences in survival of similar magnitude to those seen in Birmingham audit data (where survival at 6 months in the emergency patients was 73% vs 87% in the elective group) or those reported in a recent national audit (mortality of 15.7% following surgery for obstructing colorectal cancer and 4% following elective surgery).

    17. Planned analyses Interval analysis after recruitment of 150 patients of post-operative complications, in hospital stay, stoma formation, 30 day mortality. A primary analysis of outcome will be made once all patients have 2 years of follow up. Statistical analyses will use standard methods, e.g. comparisons of proportions by Mantel-Haenszel or Fishers exact test, logrank analyses of time to event data and multi-level model with repeated measures analysis for quality of life scores.

    18. Summary Colorectal cancer with obstruction remains an important clinical problem Colorectal stenting may reduce morbidity and mortality by converting an emergency into an elective procedure This role of stenting in this setting can only be determined by a randomised controlled clinical trial

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