W. Douglas Wong, M.D.

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Ultra-Low Sphincter Saving Procedures
- Re-defining the inferior resection limit
4th East West Colorectal Days Hungary Oct.
16-18, 2008

• W. Douglas Wong, M.D.
• Chief,Colorectal Service
• Memorial Sloan Kettering Cancer Center
• Professor of Surgery
• Cornell University Medical School

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Sphincter preserving surgery should be considered
the standard for the majority of low rectal
cancers
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How much distal margin do you need?

• 5 cm rule
• 2 cm rule
• end of the 2 cm rule

Williams et al. Reappraisal of the 5cm rule of
distal excision for carcinoma of the rectum. Br.
J Surg. 198370150-154. Pollett et al. The
relationship between the extent of distal
clearance and survival and local recurrence rates
after curative anterior resection for carcinoma
of the rectum. Ann Surg. 1983198159-163
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What is an adequate distal margin for sphincter
sparing rectal resection?

• MSKCC Studies
• Whole Mount Pathologic Analysis ( Annals of
  Surgery 2007)
• Distal Margin Analysis Study (
  Unpublished 2008 )
• Coloanal / Intersphincteric Study (
  Submitted 2008 )

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Study 1
A Prospective Pathologic Analysis Using
Whole-Mount Sections of Rectal Cancer Following
Preoperative Combined Modality TherapyImplication
s for Sphincter Preservation
Jose Guillem, David Chessin, Jinru
Shia, Arief Suriawinata, Elyn Riedel, Harvey
Moore, Bruce Minsky, and W.
Douglas Wong Annals of Surgery
2007245(1)88-93
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Aims of the Study

• To use whole mount pathologic analysis to
  characterize microscopic patterns of residual
  disease
• Circumferential margins
• Distal resection margins
• To identify clinicopathologic factors associated
  with residual disease

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Methodology

• 109 patients prospectively accrued with ERUS
  staged locally advanced rectal cancer (T2-T4 and
  /or N1)
• Median distance of 7 cm. from anal verge
• Preoperative chemoradiation followed by TME based
  resection
• Comprehensive whole mount pathologic analysis was
  performed

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Results

• Sphincter preserving resection was feasible in 87
  patients (80)
• Distal margins negative in all 109 pts
• Median 2.1 cm range 0.4 10 cm
• Intramural extension beyond gross mucosal edge of
  residual tumor was only in 2 patients (1.8 )
• Both lt .95 cm
• No positive circumferential margins although 6
  were less that 1 mm
• Median 10 mm range 1 - 28 mm
• On multivariate analysis, residual disease was
  observed more frequently in distally located
  tumors lt 5 cm from the anal verge (p.03)

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Impact of distal margin
Distal Margin Rectal Cancer

• MSK1 Whole mount analysis of 87 locally
  advanced RC after neoadjuvant CMT and LAR
• No positive margins
• 2.2 had intramural extension
• beyond mucosal edge of tumor

9.5mm
3mm
1. Guillem JG, Ann Surg. 2007 Jan245(1)88-93
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Conclusions

• Following preoperative chemoradiation and TME,
  distal margins of 1 cm seems adequate
• Occult tumor beneath the mucosal edge was rare
  and when present was limited to less that 1 cm
• These results extend the indications for
  sphincter preservation as distal resection
  margins of only 1 cm may be acceptable for
  locally advanced rectal cancer treated with
  preoperative chemoradiation

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Study 2
Distal Margin Analysis

• Nash G, Paty P, Guillem J, Temple L,
  Weiser M, and Wong D
• ( Unpublished Data 2008 )

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Distal margin rectal cancer
Study Hypotheses

• Margin of less than 8mm is associated with
  higher risk of local recurrence (LR)
• Mucosal recurrence (MR) is the mechanism of
  higher LR

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Distal margin rectal cancer
Study Cohort

• 627 patients with primary rectal cancer
• Study period 1991-2004
• Curative resection
• No involvement of adjacent organs
• Low anterior resection
• Stapled anastomosis
• Hand-sewn coloanal anastomosis (HSCAA)
• Median follow up 5.8 years

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Distal margin rectal cancer
Patient and Tumor Characteristics - LAR
Group 1 2 3 P value
Distal margin lt8mm 8-19mm 20-60mm
n 103 230 294
Age 60 years 59 53 47 0.07
Female 46 39 40 0.40
2-6cm from AV 81 57 17 lt0.001
pT3/4 16 34 54 lt0.001
pN1/2 23 29 25 0.48
M1 1 2 3 0.47
LVI 9 9 10 0.97
Preop CMT 58 61 60 0.87
Any adjuvant rx 72 76 74 0.73
DSS at 6 years 90 87 87 0.76
OS at 6 years 84 85 83 0.67
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Distal margin rectal cancer
Local recurrence
Distal margin lt8mm 8-19mm 20-60mm P-value
LR events 13/103 13/230 15/294
Absolute LR 12.6 5.7 5.1 0.006
DM 20-60mm
DM 8-19mm
DM lt 8mm
P 0.008
103 95 78 45
23 13 5 230
217 167 99 47 21
9 294 281 220
133 71 35 15
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Distal margin rectal cancer
Mucosal recurrence
Distal margin lt8mm 8-19mm 20-60mm P value
MR events 8/103 4/230 4/294
Absolute MR 7.8 1.7 1.4 lt0.001
DM 20-60mm
DM 8-19mm
DM lt 8mm
P 0.001
103 97 81 46
25 13 5 230
222 170 99 47 21
9 294 283 222 134
71 35 16
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Distal margin rectal cancer
Pelvic recurrence (excludes iMR)
Distal margin lt8mm 8-19mm 20-60mm P value
PR events 7/103 11/230 13/294
Absolute PR 6.8 4.8 4.4 0.63
DM 20-60mm
DM 8-19mm
DM lt 8mm
P 0.62
103 95 78 45
23 13 5 230
217 167 99 47 21
9 294 281 220
133 71 35 15
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Distal margin rectal cancer
Changes over time 1991-1997 and 1998-2004
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Distal margin rectal cancer
Variation of LR
n 1991-97 n 98-2004 P value
lt8 mm 41 22 62 6.5 0.02
8-19 mm 74 6.8 156 5.1 0.62
20-60 mm 127 7.9 167 3.0 0.06
All patients 242 9.9 385 4.4 0.007
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Distal margin rectal cancer
Variation of LR
n 1991-97 n 98-2004 P value
lt8 mm 41 22 62 6.5 0.02
8-19 mm 74 6.8 156 5.1 0.62
20-60 mm 127 7.9 167 3.0 0.06
All patients 242 9.9 385 4.4 0.007
Use of adjuvant therapy
n 1991-7 n 98-2004 P value
Preop CMT 286 46 462 67 lt0.001
Any adjuvant 286 65 462 78 lt0.001
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Distal margin rectal cancer
Conclusions

• Sphincter sparing techniques do not compromise
  local control or survival
• Careful surveillance for MR is warranted in
  patients with close DM
• Salvage is feasible for most MR

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Rationale for ultralow LAR/CAA
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Ultralow LAR/CAA with Intersphincteric Dissection

1. We need less distal margin than we once thought
2. Internal sphincter is an extension of the rectal
   wall

Weiser et al. Adenocarcinoma of the Colon and
Rectum. In Shackelfords Surgery of the
Alimentary Tract6th ed, 2007
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Oncologic Outcome of Coloanal Anastomosis
Author Year n Follow-up Local recurrence
Tiret et al 2003 26 39 mo 3.4
Portier et al 2007 173 67 mo 10.6
Saito et al 2006 228 41 mo 5.8
Rullier et al 2005 92 gt24 mo 2.0
Tilney et al 2007 612 9.5
literature review
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Study 3
Sphincter Preservation in low rectal cancer is
facilitated by preoperative chemoradiation and
intersphincteric dissection

• Weiser M, Quah HM, Shia J, Guillem J,
  Paty P, Temple L, Goodman K,
• Minsky B and Wong D
• ( Submitted paper 2008 )

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Aim of the Study

• To evaluate oncologic outcome in patients with
  locally advanced distal rectal cancer treated
  with preoperative chemoradiation followed by
• LAR with stapled coloanal anastomosis
• LAR with intersphincteric dissection and hand
  sewn coloanal anastomosis
• APR

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Background Data

• From a cohort of 601 consecutive patients from
  1998 2004
• 148 patients were identified with Stage II and
  III rectal cancers (ERUS Staged uT3-4 and/or N1)
  at or below 6 cm from the anal verge
• All treated with preoperative long course
• chemoradiation and TME

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Median Distal Margin

• 
  Median Distal Margin
• LAR Stapled Coloanal 1.1
  cm ( 0.9 1.3 cm)
• LAR Handsewn Intersphincteric 1.0 cm ( 0.9
  1.3 cm)
• APR
  4.0 cm ( 3.5 4.6 cm)

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Oncologic Outcome (MSKCC data)
LAR Coloanal n 41 Intersphincteric dissection n 44 APR n 63 p-value
Age 60 54 67
Male 44 57 52 ns
Distance from anal verge 6 (3-6) 5 (3-6) 3 (0-6) 0.0001
Pathologic CR 24 25 6 0.018
Poor differentiation 7 5 28 0.003
circumferential margin 0 5 13 0.11
MSKCC 2008
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Oncologic Outcome (MSKCC data)
LAR Coloanal n 41 Intersphincteric dissection n 44 APR n 63
Crude recurrence rate 6(15) 7(16) 26(41)
Local 1(2) 0(0) 6(9)
Distant 5(12) 7(16) 22(35)
5 yr RFS (95 CI) 85 83 47
5 yr DSS (95 CI) 97 96 59

MSKCC 2008
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Oncologic Outcome of Coloanal Anastomosis
N149
MSKCC 2008
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Conclusions

• In low rectal cancer, sphincter preservation is
  facilitated by significant response to
  chemoradiation and intersphincteric dissection
  without oncologic compromise
• APR is more likely required in those patients
  with lesser response to neoadjuvant therapy and
  is associated with poorer outcome

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Functional outcome of ultralow LAR
with coloanal anastomosis
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Functional Outcome after LAR/CAA

• 81 patients
• Median 2 BM / day
• Continence
• complete 51
• incontinent gas 21
• minor leak 23
• significant leak 5
• 56 excellent or good composite function
• (continence, evacuation, BMs)
• 74 of patients were satisfied

Paty et al. Long-term functional results of
coloanal anastomosis for rectal cancer. Am J
Surg. 199416790-95.
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QOL Anal Sphincter Preservation or Sacrifice

• Despite LAR patients suffering defecation
  problems, they had better QOL than APR patient
• Bowel function did not significantly impact on
  overall QOL
• Stoma patients
• More limited everyday work and hobby activities
  (role functioning)
• More disrupted social and family life (social
  functioning)
• Less able to get about and look after themselves
  (physical functioning)
• Felt less attractive (body image)
• These changes persisted over time (4 years)
• LAR scores improved with time while APR did not.
• Greatest improvement in QOL was when temporary
  stomas were reversed.

Engel et al. Quality of life in Rectal Cancer
Patients. Ann Surg 2003238203-213.
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LAR vs APR
Quality of LifeStoma vs Sphincter Preservation

• Meta-analysis
• Validated instruments
• Studies including APR and LAR
• Study included data from 11 studies
• 1443 patients
• 486 patients with APR
• All retrospective
• Validated instruments
• 4 SF-36, 7 EORTC 30, 8 EORTC CRC38

Cornish et al. Ann Surg Onc, 2007 14 2056-2068
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QOL SPS vs APR

• Overall when comparing APR to LAR, no
  differences in general QOL were identified

Cornish et al. Ann Surg Onc, 2007 14 2056-2068
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Conclusions

• A 1 cm distal margin is acceptable in patients
  undergoing neoadjuvant tx
• Ultra-low LAR/COLOANAL is oncologically sound
• Restores body image
• Majority of patients are satisfied with their QOL
  

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