Acutely Obstructing Colorectal cancer – treatment options     Jim Hill     Dukes Club 2012
Diagnosis
Pre-op. imaging
Pseudo-obstruction   Always need contrast enema/CT scan   1st line neostigmine   2nd line colonoscopic decompression  ...
Obstructing colorectal cancer   Large Bowel Cancer Project (Br J    Surg) 1985   Survival rates unchanged for 30    year...
Treatment options   Segmental resection +/-    anastomosis   Subtotal resection +/- anastomosis   Defunctioning stoma –...
Cochrane Database Syst Rev. 2004;(2):CD002101.    Curative surgery for obstruction from primary left    colorectal carcino...
Left colon-one stage resection               No. One stage Leak                   (%)       Rate (%)Stewart 1993   73    8...
Segmental resection vs Subtotal          colectomy   Scotia Study Group   increased bowel    (Br J Surg) 1995     frequen...
Extended right vs Segmental                left   Nyam et al Dis Colon Rectum 1996      no difference in bowel frequency ...
Mortality rates   Scotia Gp (Br J Surg)     1995    12%   Poon et al (Br J Surg)    1998    7%   Alvarez et al (Dig Dis...
Rationale – converting emergency          into elective surgery   Pre-operative correction and stabilisation    of fluid ...
CReST is funded by CRUK and was developed by the NCRI Colorectal                         Cancer CSGCReST
Stenting needs to be properly evaluated in arandomised controlled trial addressing two keyquestions: * Is there a worthwhi...
Eligibility criteria   Left sided colorectal cancer   Clinical or radiological evidence of    obstruction   Patient is ...
Emergency surgery  ObstructingColorectal cancer   R                           Insertion of           Failed stenting      ...
End PointsPrimary:  1. 30 day mortality  2. Length of hospital stay  Secondary:  a) Presence and duration of a stoma  b) S...
Evidence   >100 case series   4 systematic reviews   3 randomised trials
Success rates    (non randomised        studies)   Technical 92-94%,   Clinical 88-94%   Bridge-surgery 71-85%   Perfo...
NICE draft guidance   Clinical question: For patients presenting with acute large    bowel obstruction as a first present...
Dutch stent in 1 – Endoscopy 2008   21 pts with obstruction   Palliative cases   Premature closure of the trial   11 a...
2nd Dutch Stenting trial – multicentre      van Hooft Lancet Oncol 2011;12:344–52   Obstructing left sided   Primary out...
2nd Dutch Stenting trial – multicentre      van Hooft Lancet Oncol 2011; 12: 344–52   No difference    • QoL    • Mortali...
The authors concluded that colonicstenting has no decisive clinicaladvantages compared to emergencysurgery. They suggested...
French stenting trial – multi centre     – Pirlet et al Surg Endosc 2010   Obstructing left sided carcinoma   Endoscopic...
   Thus the evidence provided by published randomised trials to    date demonstrates no evidence of benefit from stenting...
Clinical question: For patients presenting with acute large bowelobstruction as a first presentation of colorectal cancer,...
“The failure to consider the directly randomised evidence on thequestion addressed is indefensible and does a disservice t...
2. Recruitment (up to 14th November 2011)          Date recruitment started:            23-Apr-2009Proposed date for recru...
First 100 patients   50 randomised to stenting   48 stent attempted   Success rate 85% (7 failures)   No perforations...
mean           23.2 (22.8)                  (s.d.)Time from stent   median (IQR)   19.5 (4 , 35)to surgery        min     ...
SAEs in stented patients having        surgery (38 patients)   Intra-abdominal abscess    2   Wound infection           ...
Summary   Colorectal community in UK has    accepted the need for a trial and is    supporting it   Recruitment is progr...
TREC Trial –Transanal Endoscopic Microsurgery (TEM) and Radiotherapy in Early          Rectal Cancer            Jim Hill  ...
Phase II feasibility study comparingradical TME surgery versus SCPRTplus delayed local excision fortreatment of early rect...
Early Rectal Cancer   10,000 new cases rectal cancer per year in England &    Wales   49 – 62% screen-detected rectal ca...
Radical Resection vs Local          ExcisionBalance of reduction inmorbidity and mortality vs risk of oncological        d...
Results of Local Excision Alone   T-Stage       Local recurrence                     %(range)      T1            9.7 (0-24...
Kikuchi levels (sm1-sm3)            2%              8%               23%              Risk of nodal metastasisNascimbeni R...
Radical Resection - morbidity & mortality   Significant morbidity (up to 60%) and    mortality (0-12%)   Wound infection...
Short Course Pre-operativeRadiotherapy   Preoperative radiotherapy    more effective than post-op RT   Pre-op can reduce...
TEMS/ TEO SITES
Endoscopic view
   50 patients randomised to stenting.   47 have a stent insertion date recorded.   3 don’t (1071, 1086, 1088)   Reaso...
   Of the 48 with a stent date recorded:   38 have a surgery date   10 don’t.   Good reasons for not having a surgery ...
CReST RecruitmentProposed date for recruitment to end:   Oct-2012Total number to be recruited:           400Number recruit...
Benign disease   Small et al, Surg Endosc 2008   23 cases   Clinical success 22/23   Major complications 38%   87% oc...
Planned analyses   Interval analysis after recruitment of 150    patients of post-operative complications,    in hospital...
Conclusions of randomised trials           reported to date   No proven benefit for all comers    compared to emergency s...
Exclusion criteria   Patients with signs of peritonitis and/or    perforation   Patients with obstruction in the rectum,...
Martinez-Santoz et al, Dis Colon             Rectum 2002   Emergency surgery (n=29)   Pre-operative stent and elective s...
Statistical Power   400 patients will be randomized over three years    from 40 centres in the UK and selected centres   ...
Statistical Power   90% power to detect a 0.35sd reduction in    days in hospital equivalent to 1-2 days. It    is not an...
Statistical Power   Adequate to detect a 50% reduction in 30-day    mortality with stenting and elective surgery    compa...
Sebastian et al, Am J Gastroenterol                2004   Pooled analysis of 1,198 patients in    54 studies.   Median t...
Statistical Power   400 patients   90% power to detect differences in mortality if    similar to those reported in a rec...
CReST to date   125 pts recruited   33 recruiting centres   50 sites open
Presentation and Outcome   COLORECTAL CANCERMode of         % of all       In-hospital   5 yrpresentation        patients ...
COMPARING OPERATIVE SURVIVAL IN EMERGENCY & ELECTIVE                                                       CASES          ...
Stenting workshops   Combined endoscopic/fluoroscopic    technique recommended   Double channel gastroscope   No pre or...
Systematic reviews   Little high level evidence   No data QoL and economic analysis   Little long term/survival data
   2007 UK National Bowel Cancer Audit    Project reported an 11 per cent    mortality after colonic stenting for    obst...
NICE stakeholder comments
Stenting vs open surgery       Tilney et at Surg Endosc 2007   451 pts   Lower mortality p<0.03   LOS shorter by 7.7 da...
Watt et al Ann Surg 2007   88 articles,   Mortality comparable   Shorter LOS   Lower colostomy rates   Lower complica...
Serious Adverse Events SAEs – fatal, life-threatening, require or prolong hospitalisation or aresignificantly or permanen...
QuestionIn the absence of any randomisedclinical trial showing a benefit ofstenting in patients with obstructingleft sided...
Left colon-Staged resection   Cahill et al (Annals RCSE) 1991      44% prefer Hartmann   Wigmore et al (Br J Surg) 1995 ...
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill
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Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill

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Mr Jim Hill's presentation on the management of obstructing colorectal cancer. Talk given at Dukes' Club weekend 2012

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  • CReST is funded by CRUK and was developed by the NCRI Colorectal Cancer CSG CReST is funded by CRUK and was developed by the NCRI Colorectal Cancer CSG
  • Is the question worth answering
  • Acutely Obstructing Colorectal Cancer – Treatment Options- Jim Hill

    1. 1. Acutely Obstructing Colorectal cancer – treatment options Jim Hill Dukes Club 2012
    2. 2. Diagnosis
    3. 3. Pre-op. imaging
    4. 4. Pseudo-obstruction Always need contrast enema/CT scan 1st line neostigmine 2nd line colonoscopic decompression 3rd line surgery
    5. 5. Obstructing colorectal cancer Large Bowel Cancer Project (Br J Surg) 1985 Survival rates unchanged for 30 years Primary anastomosis established right side Primary resection 60% left side, 31% primary anastomosis
    6. 6. Treatment options Segmental resection +/- anastomosis Subtotal resection +/- anastomosis Defunctioning stoma – loop ileostomy, loop colostomy, caecostomy SEMS
    7. 7. Cochrane Database Syst Rev. 2004;(2):CD002101. Curative surgery for obstruction from primary left colorectal carcinoma: primary or staged resection? De Salvo GL, Gava C, Pucciarelli S, Lise M REVIEWERS CONCLUSIONS: The limited number of identified trials together with their methodological weaknesses do not allow a reliable assessment of the role of either therapeutic strategy in the treatment of patients with bowel obstruction from colorectal carcinoma. It would appear advisable to conduct high quality large scale RCT to establish which treatment is more effective. However, it is doubtful whether they could be carried out in a timely and satisfactory way in this particular surgical context
    8. 8. Left colon-one stage resection No. One stage Leak (%) Rate (%)Stewart 1993 73 86 6Runkel 1998 35 63 5Poon 1998 116 81 5Deen 1998 143 85 1
    9. 9. Segmental resection vs Subtotal colectomy Scotia Study Group increased bowel (Br J Surg) 1995 frequency in subtotal group Torralba et al post operative (Dis Colon diarrhoea Rectum) 1994 in 31%
    10. 10. Extended right vs Segmental left Nyam et al Dis Colon Rectum 1996 no difference in bowel frequency no difference in complications
    11. 11. Mortality rates Scotia Gp (Br J Surg) 1995 12% Poon et al (Br J Surg) 1998 7% Alvarez et al (Dig Dis) 2005 11% Poon et al (Dis Col Rectum) 2005 11% McGillicuddy et al (Arch Surg) 2009 15%
    12. 12. Rationale – converting emergency into elective surgery 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
    13. 13. CReST is funded by CRUK and was developed by the NCRI Colorectal Cancer CSGCReST
    14. 14. Stenting needs to be properly evaluated in arandomised controlled trial addressing two keyquestions: * Is there a worthwhile net benefit (in reduced operativemortality and morbidity, reduced stoma formation andbetter quality of life adjusted survival) from endoluminalstenting for patients presenting with an obstructingcolonic cancer? * If a benefit exists, is this identifiable in patientsundergoing attempted curative treatment, palliativetreatment, or both?
    15. 15. Eligibility criteria Left sided colorectal cancer Clinical or radiological evidence of obstruction Patient is fit for surgery Responsible doctor feels that there may be some benefit to the patient from stenting as a bridge to surgery
    16. 16. Emergency surgery ObstructingColorectal cancer R Insertion of Failed stenting endoluminal stent Palliative care Successful decompression Elective surgery
    17. 17. End PointsPrimary: 1. 30 day mortality 2. Length of hospital stay Secondary: a) Presence and duration of a stoma b) Stenting completion and complication rate c) Anastomosis rate d) Quality of life (EQ 5D and EORTC QLQ-CR 29) e) Overall survival f) Disease-free survival at three years (attempted curative surgery group only) g) Length of stay on ITU or HDU h) In-hospital morbidity i) Cost benefit analysis j) Rate of adjuvant chemotherapy (stage II and stage III cancer) and adherence to chosen chemotherapy protocols
    18. 18. Evidence >100 case series 4 systematic reviews 3 randomised trials
    19. 19. Success rates (non randomised studies) Technical 92-94%, Clinical 88-94% Bridge-surgery 71-85% Perforation 4% Migration 10% Obstruction 10%
    20. 20. NICE draft guidance Clinical question: For patients presenting with acute large bowel obstruction as a first presentation of colorectal cancer, what are the indications for stenting as a bridge to elective surgery? What are the indications for stenting patients and the optimal timing for stenting to occur? Clinical evidence There is very little evidence of any type with which to address this topic. There are no directly applicable studies and so in assessing the body of evidence, consideration was given to the possibility that relevant evidence may not be directly available and so studies which compared stenting as a bridge to surgery, stenting for palliative purposes or immediate emergency surgery were also reviewed to check whether these studies contained information relevant to the topic. Despite this consideration, very little evidence of relevance was found from these studies and what was available was of very poor quality.
    21. 21. Dutch stent in 1 – Endoscopy 2008 21 pts with obstruction Palliative cases Premature closure of the trial 11 adverse events in stenting arm 6 perforations • 4 early • 2 late on chemotherapy
    22. 22. 2nd Dutch Stenting trial – multicentre van Hooft Lancet Oncol 2011;12:344–52 Obstructing left sided Primary outcome measure QoL 98 cases randomised Increased 30 day morbidity in stent gp (absolute risk increase 0.19) Trial currently halted by DMEC
    23. 23. 2nd Dutch Stenting trial – multicentre van Hooft Lancet Oncol 2011; 12: 344–52 No difference • QoL • Mortality • Stoma rates Stent group • Perforation 13% • Successfully placed in 70% (all relieved obstruction) • 31 pts bridge to surgery  Primary anastomosis in 20 (25% leak rate)  3 silent perforations found histologically
    24. 24. The authors concluded that colonicstenting has no decisive clinicaladvantages compared to emergencysurgery. They suggested that it could beused as an alternative treatment in as yetundefined subsets of patients, althoughwith caution because of concerns abouttumour spread caused by perforations.
    25. 25. French stenting trial – multi centre – Pirlet et al Surg Endosc 2010 Obstructing left sided carcinoma Endoscopic or radiological 60 patients randomised 53% technical failure stenting arm No reduction in stoma rates • 43% stenting arm, 56% emergency surgery 2/30 perforations in stenting arm Trial stopped early
    26. 26.  Thus the evidence provided by published randomised trials to date demonstrates no evidence of benefit from stenting and importantly describes increased morbidity associated with stenting. The key questions relating to the use of stents in obstructing colorectal cancer remain unanswered. These questions can only be answered by a large randomised trial. The current status of stenting in obstructing colorectal cancer is analogous to the status of laparoscopic surgery for colorectal cancer in 2000. People should only have laparoscopic surgery as part of a clinical trial. In view of all the above we feel most strongly that the planned NICE Colorectal Cancer guidelines should state that; in patients fit enough to undergo emergency surgery, stenting in obstructing colorectal cancer should be limited to clinical trials so that we can be clear about its benefit and risks.
    27. 27. Clinical question: For patients presenting with acute large bowelobstruction as a first presentation of colorectal cancer, what are the indications for stenting as a bridge to elective surgery? What are the indications for stenting patients and the optimal timing for stenting to occur? The guidance on Improving outcomes in colorectal cancer‘ (2004) recommended stent insertion instead of emergency surgery for patients with acute bowel obstruction. Consequently the question investigated by this guideline focused on the indications and optimal timing for stent insertion to occur. The evidence you cite relates to the issue of stent insertion vs emergency surgery and is therefore not relevant to the topic which was considered by the guideline.
    28. 28. “The failure to consider the directly randomised evidence on thequestion addressed is indefensible and does a disservice topatients and their medical carers. As this randomised evidencepoints to the potential for serious harm as a result of insertion ofSEMS in patients with obstructing colorectal cancer, the NICEGuidance’s recommendation that colorectal surgeons shouldconsider inserting a colonic stent in patients presenting with acutelarge bowel obstruction, without mention that randomised trialshave failed to establish superiority of SEMS over decompressionsurgery, is ”perverse”. The appropriate recommendation - and theconclusion of the authors of all three randomised trials (seebelow) - is that stenting as a bridge to surgery remains anexperimental procedure requiring further randomised evidence toestablish its clinical and cost-effectiveness. The newly publishedguidance on SEMS should be corrected or withdrawn”.
    29. 29. 2. Recruitment (up to 14th November 2011) Date recruitment started: 23-Apr-2009Proposed date for recruitment to end: Extended to August 2013 Total number to be recruited: 400 Number recruited to date: 123
    30. 30. First 100 patients 50 randomised to stenting 48 stent attempted Success rate 85% (7 failures) No perforations 38 surgery 10 no surgery • 7 palliative cases • 1 MI before surgery • 1 benign disease • 1 unknown
    31. 31. mean 23.2 (22.8) (s.d.)Time from stent median (IQR) 19.5 (4 , 35)to surgery min 0 max 103
    32. 32. SAEs in stented patients having surgery (38 patients) Intra-abdominal abscess 2 Wound infection 2 PE 2 Myocardial 1 Urinary 2 Chest infection 3 Constipation 1 No anastomotic leaks but no. primary anastomosis unknown
    33. 33. Summary Colorectal community in UK has accepted the need for a trial and is supporting it Recruitment is progressing at a satisfactory rate Safety data is reassuring Given concerns raised by stenting trials, CReST trial is important Current NICE guidance is disservice to patients
    34. 34. TREC Trial –Transanal Endoscopic Microsurgery (TEM) and Radiotherapy in Early Rectal Cancer Jim Hill Manchester Royal Infirmary
    35. 35. Phase II feasibility study comparingradical TME surgery versus SCPRTplus delayed local excision fortreatment of early rectal cancer (T1-T2)
    36. 36. Early Rectal Cancer 10,000 new cases rectal cancer per year in England & Wales 49 – 62% screen-detected rectal cancers are “early” (pT1-2N0M0) Standard of care: Total Mesorectal Excision (TME) High rates of cure (3-6% relapse) Significant high mortality (3-4%) & post-operative morbidity
    37. 37. Radical Resection vs Local ExcisionBalance of reduction inmorbidity and mortality vs risk of oncological disaster
    38. 38. Results of Local Excision Alone T-Stage Local recurrence %(range) T1 9.7 (0-24) T2 25 (0-50) T3 38 (0-100)
    39. 39. Kikuchi levels (sm1-sm3) 2% 8% 23% Risk of nodal metastasisNascimbeni R, Burgart LJ, Nivatvongs S, Larson DR.Dis Colon & Rectum 2002
    40. 40. Radical Resection - morbidity & mortality Significant morbidity (up to 60%) and mortality (0-12%) Wound infections, wound and parastomal herniae, urinary /sexual dysfunction, anastomatic leakage, stoma issues, anterior resection syndrome, incontinence APR: Perineal wound and stoma- related physical, psychological and financial cost
    41. 41. Short Course Pre-operativeRadiotherapy Preoperative radiotherapy more effective than post-op RT Pre-op can reduce local recurrence following TME Can induce tumour shrinkage or even complete pathological response Interval between SCPRT and surgery key to downstaging Surgery follows 1 week after traditional schedules of SCPRT
    42. 42. TEMS/ TEO SITES
    43. 43. Endoscopic view
    44. 44.  50 patients randomised to stenting. 47 have a stent insertion date recorded. 3 don’t (1071, 1086, 1088) Reasons for not having a stent insertion date are as follows: 1 not eligible - small bowel tumour on review (1071) 1 small bowel obstruction/fistula – going straight to surgery (1086) 1 stent attempted but failed – missing date. Assumed to be = date of surgery = 1 day after rand. (1088)
    45. 45.  Of the 48 with a stent date recorded: 38 have a surgery date 10 don’t. Good reasons for not having a surgery date are as follows: 7 palliative (1016, 1034, 1051, 1059, 1062, 1068, 1069) 1 died before surgery (1022) Bad reasons for not having a surgery date are as follows: (forms being chased) 1 possible non-cancer (1092) 1 unknown (1043)
    46. 46. CReST RecruitmentProposed date for recruitment to end: Oct-2012Total number to be recruited: 400Number recruited to date, 19-Nov-10: 65
    47. 47. Benign disease Small et al, Surg Endosc 2008 23 cases Clinical success 22/23 Major complications 38% 87% occurred after 7 days
    48. 48. 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 Fisher’s exact test, logrank analyses of time to event data and multi-level model with repeated measures analysis for quality of life scores.
    49. 49. Conclusions of randomised trials reported to date No proven benefit for all comers compared to emergency surgery May be useful in selected patients (? Which ones) Further studies needed to look at oncological outcomes
    50. 50. Exclusion criteria Patients with signs of peritonitis and/or 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
    51. 51. 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)
    52. 52. Statistical Power 400 patients will be randomized over three years from 40 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 emergency surgery (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).
    53. 53. 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
    54. 54. Statistical Power Adequate to detect a 50% reduction in 30-day mortality with stenting and elective surgery compared to primary anastomosis 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).
    55. 55. 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%.
    56. 56. Statistical Power 400 patients 90% power to detect differences in mortality if similar to those reported in a recent national audit (mortality of 15.7% following surgery for obstructing colorectal cancer and 4% following elective surgery). 90% power to detect a 0.35sd reduction in days in hospital equivalent to 1-2 days. 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).
    57. 57. CReST to date 125 pts recruited 33 recruiting centres 50 sites open
    58. 58. Presentation and Outcome COLORECTAL CANCERMode of % of all In-hospital 5 yrpresentation patients mortality survivalElective surgery 60 5 50Emergency 25 20 25Non-operative 15 40
    59. 59. COMPARING OPERATIVE SURVIVAL IN EMERGENCY & ELECTIVE CASES 1 N = 502 0.95 Elective Emergency 0.9Cumulative Survival 0.85 0.8 0.75 0.7 0 100 200 300 400 500 600 Time (days)
    60. 60. Stenting workshops Combined endoscopic/fluoroscopic technique recommended Double channel gastroscope No pre or post stent insertion dilatation allowed Stent of radiologists/endoscopists choice Confidence levels of radiologists high No specific colonic stent numbers
    61. 61. Systematic reviews Little high level evidence No data QoL and economic analysis Little long term/survival data
    62. 62.  2007 UK National Bowel Cancer Audit Project reported an 11 per cent mortality after colonic stenting for obstructing cancers The authors commented that this was higher than in previously published reports and needed further study
    63. 63. NICE stakeholder comments
    64. 64. Stenting vs open surgery Tilney et at Surg Endosc 2007 451 pts Lower mortality p<0.03 LOS shorter by 7.7 days Stenting did not affect survival
    65. 65. Watt et al Ann Surg 2007 88 articles, Mortality comparable Shorter LOS Lower colostomy rates Lower complications
    66. 66. Serious Adverse Events SAEs – fatal, life-threatening, require or prolong hospitalisation or aresignificantly or permanently disabling For purposes of trial, adverse events include, but aren’t limited to: - Failure to deploy the stent - Bowel perforation - Stent displacement All SAEs reported to BCTU within 24 hrs
    67. 67. QuestionIn the absence of any randomisedclinical trial showing a benefit ofstenting in patients with obstructingleft sided colorectal cancer andconcerns about stenting (sufficient tostop the trials) in the only threerandomised trials so far conducted,should stenting be offered outside arandomised trial?
    68. 68. Left colon-Staged resection Cahill et al (Annals RCSE) 1991 44% prefer Hartmann Wigmore et al (Br J Surg) 1995 32-60% never reanastomosed

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