a. montori m.d. f.a.c.s. professor of surgery university of rome “la sapienza” president of...

A. MONTORI A. MONTORI M.D. F.A.C.S.M.D. F.A.C.S.PROFESSOR OF SURGERYPROFESSOR OF SURGERY

UNIVERSITY OF ROME “LA SAPIENZA”UNIVERSITY OF ROME “LA SAPIENZA”President of EAcSSPresident of EAcSS

HOW TO AVOID MAJOR SURGERY IN HOW TO AVOID MAJOR SURGERY IN

RECTAL CANCERRECTAL CANCER

MSO-MTCC PGMSO-MTCC PGTRIPOLI October 1TRIPOLI October 1STST 2010 2010

LOCAL EXCISION FOR RECTAL NEOPLASMSLOCAL EXCISION FOR RECTAL NEOPLASMS

THE LOCAL EXCISION OF RECTAL NEOPLASMS STILL THE LOCAL EXCISION OF RECTAL NEOPLASMS STILL REPRESENTS A VERY CONTROVERSIAL ISSUE:REPRESENTS A VERY CONTROVERSIAL ISSUE:

• The nature of the lesion (benign or malignant)The nature of the lesion (benign or malignant)

• The location (distance from anal verge)The location (distance from anal verge)

• The metodology to be usedThe metodology to be used

• The progress of technologyThe progress of technology

• The different approach (Surgical or Endoscopic)The different approach (Surgical or Endoscopic)

• The results obtained The results obtained

• The radicality of the intervention (Long-Term survival - QoL)The radicality of the intervention (Long-Term survival - QoL)

LOCAL EXCISION FOR RECTAL CANCERLOCAL EXCISION FOR RECTAL CANCER

LOCAL EXCISION OF RECTAL CANCER IN LOW-RISK LOCAL EXCISION OF RECTAL CANCER IN LOW-RISK

PATIENTS IS APPEALING BUT IT PROVIDES LIMITED PATIENTS IS APPEALING BUT IT PROVIDES LIMITED

CONTROL OF THE DISEASECONTROL OF THE DISEASE

(LACK OF “N” STAGING).(LACK OF “N” STAGING). NEVERTHELESS IN THE RECENT NEVERTHELESS IN THE RECENT

YEARS IT IS POSSIBLE TO ACHIEVE A CORRECT YEARS IT IS POSSIBLE TO ACHIEVE A CORRECT

PREOPERATIVE TUMOR AND PREOPERATIVE TUMOR AND NODE STAGING NODE STAGING DUE TO THE DUE TO THE

SIGNIFICANT IMPROVEMENT OF THE TRANSANAL SIGNIFICANT IMPROVEMENT OF THE TRANSANAL

ULTRASOUND, MRI, LYNPHOSCINTIGRAFY, ELICOIDAL CT ULTRASOUND, MRI, LYNPHOSCINTIGRAFY, ELICOIDAL CT

SCAN IMAGING.SCAN IMAGING.

NORMAL ( FIVE LAYERSNORMAL ( FIVE LAYERS ) T 1T 1 T 3 N 1T 3 N 1

TRANSRECTAL USTRANSRECTAL US

VIRTUAL ENDOSCOPYVIRTUAL ENDOSCOPY


• DIGIT EXPLORATIONDIGIT EXPLORATION

• TUMOR MARKERSTUMOR MARKERS

• RETTOSIGMOIDOSCOPYRETTOSIGMOIDOSCOPY

(BIOPSY: (BIOPSY: microbiopsies for gradingmicrobiopsies for grading - - TATOO: TATOO: defining the excisional linedefining the excisional line) )

• ENDOSCOPIC LYMPHOSCINTIGRAPHY ENDOSCOPIC LYMPHOSCINTIGRAPHY

•TRANSRECTAL US (T-n)TRANSRECTAL US (T-n)

• TC SCAN (Spiral TC Scan and Virtual Endoscopy (T-n)TC SCAN (Spiral TC Scan and Virtual Endoscopy (T-n)

• MRI (T-n)MRI (T-n)

• BONESCANBONESCAN

FLEXIBLEFLEXIBLE(colonoscopy)(colonoscopy)

RIGIDRIGID

ENDOSCOPY: 10-15 mm normal mucosa biopsies & biopsies & tatootatoo

Defined excinal line on hystol. ass normal mucosa • Eval. post RxTerapy response• Follow up

Macrobiopsies for grading

ENDOSCOPIC LYNPHOSCINTIGRAFYENDOSCOPIC LYNPHOSCINTIGRAFY

1.0 ml colloidal rhenium sulfide marked with 1.0 ml colloidal rhenium sulfide marked with 99m99mTCTC

TRANSRECTAL US (N 1 )TRANSRECTAL US (N 1 )


• TRANSANAL APPROACH:TRANSANAL APPROACH: PAPILLON: PAPILLON: Parachute TechniqueParachute Technique

PARKS PARKS

MAEDA 2004: MAEDA 2004: Minimally Invasive Transanal Surgery - MITASMinimally Invasive Transanal Surgery - MITAS))

• INTERSPHINTERIC EXCISION (MASON)INTERSPHINTERIC EXCISION (MASON)

• TRANS-SACRAL APPROACH (KRASKE)TRANS-SACRAL APPROACH (KRASKE)

• TRANSANAL ENDOSCOPIC MICROSURGERY TEM (BUESS 1984)TRANSANAL ENDOSCOPIC MICROSURGERY TEM (BUESS 1984)

• (ENDOSCOPIC MUCOSAL RESECTION AND SUBMUCOSAL DISSECTION FOR ADENOMA)(ENDOSCOPIC MUCOSAL RESECTION AND SUBMUCOSAL DISSECTION FOR ADENOMA)

SURGICAL APPROACHSURGICAL APPROACH

ENDOSCOPIC APPROACHENDOSCOPIC APPROACH

TRANSANAL APPROACH (PAPILLON: TRANSANAL APPROACH (PAPILLON: Parachute Technique)Parachute Technique)



•TRANSANAL APPROACH (PARKS)TRANSANAL APPROACH (PARKS)

Minimally Invasive Transanal Surgery - Minimally Invasive Transanal Surgery - MITASMITAS MAEDA et al. 2004MAEDA et al. 2004


INTERSPHINTERIC EXCISION (MASON)INTERSPHINTERIC EXCISION (MASON)



•TRANS-SACRAL APPROACH (KRASKE)TRANS-SACRAL APPROACH (KRASKE)

LOCAL EXCISION FOR RECTAL ADENOMA & CANCERLOCAL EXCISION FOR RECTAL ADENOMA & CANCER

TRANSANAL ENDOSCOPIC MICROSURGERY (TEM)TRANSANAL ENDOSCOPIC MICROSURGERY (TEM)

- G. BUESS 1984 (ADENOMA)- G. BUESS 1984 (ADENOMA)

- E.LEZOCHE 1996 (CANCER)- E.LEZOCHE 1996 (CANCER)

G. BUESSG. BUESS

FULL THIKNESS + “local perirectal fat “ EXCISION”

SHAPE OF THE SPECIMEN IS LIKE A

TRUNCATED PYRAMID

WE START TO THINK THAT RECTAL CANCER COULD WE START TO THINK THAT RECTAL CANCER COULD BE TREATED WITH LOCAL EXCISION NEARLY BE TREATED WITH LOCAL EXCISION NEARLY

25 YEARS AGO!25 YEARS AGO!

Int J Colorect Dis (1986) 1:208-211Int J Colorect Dis (1986) 1:208-211

Surg Endosc (1987) 1:113-117Surg Endosc (1987) 1:113-117

NEED FOR ADJUVANT THERAPYNEED FOR ADJUVANT THERAPY

• RADIOTHERAPY RADIOTHERAPY (Full Dose: 5,040 cGy - 4 weeks)(Full Dose: 5,040 cGy - 4 weeks)

• CHEMOTHERAPY CHEMOTHERAPY (5 fu cont. infusion 200mg/m2/day for 2 weeks)(5 fu cont. infusion 200mg/m2/day for 2 weeks)

• (IMMUNOTHERAPY)(IMMUNOTHERAPY)


OUR EXPERIENCE OUR EXPERIENCE 1987-1992: 1987-1992:

XRT XRT (FULL DOSE) (26 Pts)(26 Pts)


LOCAL RECURRENCES 3 Pts LOCAL RECURRENCES 3 Pts (mean follow up 30 months)(mean follow up 30 months)

T1 5T1 5

T2 12T2 12

T3 9T3 9

T0 3T0 3 T1 14T1 14

T2 7T2 7

T3 2T3 2

DOWNSTAGINGDOWNSTAGING LOCAL EXCISIONLOCAL EXCISION

PREPRE POSTPOST

OUR EXPERIENCE OUR EXPERIENCE 1992 - 2001: 1992 - 2001: XRT+CHTXRT+CHT(11 Pts)(11 Pts)


LOCAL RECURRENCES 1 Pts LOCAL RECURRENCES 1 Pts (mean follow up 30 months)(mean follow up 30 months)

T1 4T1 4

T2 4T2 4

T3 3T3 3

T0 5T0 5 T1 4T1 4

T2 2T2 2

T3 0T3 0

DOWNSTAGINGDOWNSTAGING LOCAL EXCISIONLOCAL EXCISION

PREPRE POSTPOST


WE CAN CONCLUDE THAT IN OUR EXPERIENCE, WE CAN CONCLUDE THAT IN OUR EXPERIENCE,

NEOADJUVANT XRT+CHT GIVE A BETTER RESPONSE AS NEOADJUVANT XRT+CHT GIVE A BETTER RESPONSE AS

FAR AS LOCAL EXCISION FOR RECTAL CANCER IS FAR AS LOCAL EXCISION FOR RECTAL CANCER IS

CONCERNED.CONCERNED.

Angelita Habr-Gama Dis Colon Rectum 1998Angelita Habr-Gama Dis Colon Rectum 1998

ACCORDING TO A.HABR-GAMA 30.5% OF Pts WITH ACCORDING TO A.HABR-GAMA 30.5% OF Pts WITH

DOWNSTAGING (T0) DO NOT NEED SURGERY. DOWNSTAGING (T0) DO NOT NEED SURGERY.

LOCAL EXCISION FOR RECTAL CANCERS IS ASSOCIATED WITH LOCAL EXCISION FOR RECTAL CANCERS IS ASSOCIATED WITH

A LOW MORBIDITY AND PROVIDES SATISFACTORY LOCAL A LOW MORBIDITY AND PROVIDES SATISFACTORY LOCAL

CONTROL AND DISEASE-FREE SURVIVAL RATES FOR T1 CONTROL AND DISEASE-FREE SURVIVAL RATES FOR T1

RECTAL CANCER. RECTAL CANCER.

THERE WAS, HOWEVER, A NEED FOR A THERE WAS, HOWEVER, A NEED FOR A RANDOMIZED, RANDOMIZED,

CONTROLLED TRIALCONTROLLED TRIAL FOR T2 CANCERS, COMPARING LOCAL FOR T2 CANCERS, COMPARING LOCAL

EXCISION (FULL THICKNESS ABLATION WITH RDT-CHT) TO EXCISION (FULL THICKNESS ABLATION WITH RDT-CHT) TO

RADICAL RESECTION.RADICAL RESECTION.


INCLUSION CRITERIAINCLUSION CRITERIA

Patients staged as TPatients staged as T22NN0 0 GG1-2 1-2 ::

• tumour diameter lower than 3 cmtumour diameter lower than 3 cm• within 6 cm from the anal vergewithin 6 cm from the anal verge

TEM TEM VSVS LAPAROSCOPIC RESECTION LAPAROSCOPIC RESECTION

Lezoche & coll. Surg. Endoscopy 2005Lezoche & coll. Surg. Endoscopy 2005

AIM OF THE STUDYAIM OF THE STUDY

To compare the results of two minimally invasive procedure (TEM To compare the results of two minimally invasive procedure (TEM vsvs LaparoscopicLaparoscopic Low Anterior Resection or Low Anterior Resection or LaparoscopicLaparoscopic Abdominal Perineal Abdominal Perineal Resection) in the treatment of low rectal cancer. Resection) in the treatment of low rectal cancer.


posterior pelvic mobilization of the rectumwith nerve sparing

TOTAL MESORECTAL EXCISION

INFACT IT IS WELL KNOWN THAT LAP COLORECTAL RESECTION IS LESS INFACT IT IS WELL KNOWN THAT LAP COLORECTAL RESECTION IS LESS IMMUNOSUPPRESIVE THAN THE OPEN APPROACHIMMUNOSUPPRESIVE THAN THE OPEN APPROACH

EXCLUSION CRITERIAEXCLUSION CRITERIA

Evidence of local or distance metastasesEvidence of local or distance metastases

Other malignancies in historyOther malignancies in history


Exclusion criteria for radiotherapy:Exclusion criteria for radiotherapy: severe diverticular disease or previusly radiotherapysevere diverticular disease or previusly radiotherapy

Exclusion criteria for chemotherapy:Exclusion criteria for chemotherapy:patients older than 70 years and/or with compromised general patients older than 70 years and/or with compromised general conditionsconditions


Prospective randomized trialProspective randomized trial

40 patients T40 patients T22NN0 0 GG1-2 1-2

with 3 year follow-up were randomized to:with 3 year follow-up were randomized to:

20 patients to TEM20 patients to TEM 20 patients to Lap. Resect.20 patients to Lap. Resect.(arm A)(arm A) (arm B)(arm B)


posterior pelvic mobilization of the rectumwith nerve sparing

TOTAL MESORECTAL EXCISION

ANAGRAPHIC DATAANAGRAPHIC DATA

TEMTEM VSVS LAPAROSCOPIC RESECTIONLAPAROSCOPIC RESECTION

TEM TEM n=20n=20 LR LR n=20n=20

Gender, male Gender, male [n, (%)][n, (%)] 12 (60)12 (60) 13(65)13(65)

pp

n.s.*n.s.*

Age (years)Age (years)[median, (25[median, (25th th p-75p-75thth p)] p)]

6868(64-70)(64-70)

6767(62-68)(62-68) n.s.n.s.##

Range (years)Range (years) 34-7434-74 48-7848-78

* Chi-Square Test* Chi-Square Test # Wilcoxon Test# Wilcoxon TestLezoche & coll. Surg. Endoscopy 2005Lezoche & coll. Surg. Endoscopy 2005

RADIOTHERAPY DOWNSTAGERADIOTHERAPY DOWNSTAGE

TEM TEM VSVS LAPAROSCOPIC RESECTIONLAPAROSCOPIC RESECTION


Radiotherapy downstageRadiotherapy downstage 7 p T07 p T06 p T16 p T1

7 p T07 p T04 p T14 p T1

pp

n.s *n.s *

Reduction > 50%Reduction > 50% 44 66 n.s *n.s *

No significative effectNo significative effect 33 33 n.s.*n.s.*

* Chi-Square Test* Chi-Square Test


INTRAOPERATIVE COMPLICATIONSINTRAOPERATIVE COMPLICATIONS



Conversions: - Conversions: - to open to open - lap. LAR to lap. APR- lap. LAR to lap. APR

0000

2 2 2 2

pp

0.050.05

Operative time Operative time (minutes) (minutes)

110 (45-210)110 (45-210) 196 (150-300)*196 (150-300)*172(130-210)**172(130-210)**

0.001# 0.001#

Blood lossBlood loss (ml)(ml) 4545 250(100-700)250(100-700) 0.001 #0.001 #

TransfusionsTransfusions(n. of patients)(n. of patients)

-- 44 0.053 ^0.053 ^

* Laparoscopic low anterior resection **Laparoscopic Miles procedure* Laparoscopic low anterior resection **Laparoscopic Miles procedure

# Wilcoxon Test# Wilcoxon Test ^Fisher Exact Test^Fisher Exact Test

STOMASTOMA



No StomaNo Stoma

20 (100 %)20 (100 %) 12 (60 %)12 (60 %)

pp

0.016^0.016^

temporary ileostomytemporary ileostomy 00 4 (20 %)4 (20 %)

definitive colostomydefinitive colostomy 00 4 (20 %)4 (20 %)

^Fisher Exact Test^Fisher Exact Test

INTRAOPERATIVE COMPLICATIONSINTRAOPERATIVE COMPLICATIONS



Analgesic (n. of pts) Analgesic (n. of pts) 22 2020

pp

0.001*0.001*

Hospital Stay Hospital Stay (days) (days)

4.5 (3-6)4.5 (3-6) 7.5 (6 –10)7.5 (6 –10) 0.001#0.001#

No p.o. Complicat.No p.o. Complicat.MinorMinorMajorMajor

17 (85%)17 (85%)2 (10%)2 (10%)11 (temp. (temp.

ileostomy)ileostomy)

17 ( 85 %)17 ( 85 %)2 (10 %)2 (10 %)

1 1 (temp. ileostomy)(temp. ileostomy)n.s ^n.s ^ n.s ^n.s ^

* Chi-Square Test # Wilcoxon Test * Chi-Square Test # Wilcoxon Test ^Fisher Exact Test^Fisher Exact Test

FOLLOW-UP 48 FOLLOW-UP 48 months months (36-76)(36-76)



Local recurrence Local recurrence 1 1 ((at 6 mo., at 6 mo., APR 15 mo. disease freeAPR 15 mo. disease free))

1 (dead)1 (dead)

Distant metastases Distant metastases 1 1 (dead after hepatic(dead after hepaticresection)resection)

Disease freeDisease freesurvival ratesurvival rate 85%85% 80%80%

1 (dead)1 (dead)

* Chi-Square Test # Wilcoxon Test * Chi-Square Test # Wilcoxon Test ^Fisher Exact Test^Fisher Exact Test

CONCLUSIONS 1CONCLUSIONS 1


According to the study design in our experience TEM According to the study design in our experience TEM

versusversus LR with preoperative chemoradiotherapy has achieved LR with preoperative chemoradiotherapy has achieved

no significant difference in terms of:no significant difference in terms of:

• probability of local recurrence or distant metastases (5%) probability of local recurrence or distant metastases (5%) • disease free survival rate (85% in arm A and 80% and B )disease free survival rate (85% in arm A and 80% and B )• post operative complicationspost operative complications

CONCLUSIONS 2CONCLUSIONS 2


According to the study design in our experience TEM According to the study design in our experience TEM versusversus LR LR

with preoperative chemoradiotherapy has achieved significative with preoperative chemoradiotherapy has achieved significative

better results in terms of:better results in terms of:

• n. of temporary & definitive stoma (p 0.016)n. of temporary & definitive stoma (p 0.016)

• convertion rate (p 0.05)convertion rate (p 0.05)

• operative time (p 0.001)operative time (p 0.001)

• blood loss (p 0.001) and necessity of trasfusions blood loss (p 0.001) and necessity of trasfusions

• use of analgesic (p 0.001)use of analgesic (p 0.001)

• hospital stay (p 0.001)hospital stay (p 0.001)

CONCLUSIONS 3 CONCLUSIONS 3

ADVANTAGES OF TEMADVANTAGES OF TEM


• low operative traumalow operative trauma• more rapid return tomore rapid return to -- normal respiratory functions normal respiratory functions -- quick ambulation quick ambulation

-- normal activities normal activities• better cosmetic resultsbetter cosmetic results

THE LOCAL EXCISION OF THE RECTAL CANCER STILL REPRESENTS TODAY THE LOCAL EXCISION OF THE RECTAL CANCER STILL REPRESENTS TODAY

A VERY CONTROVERSIAL ISSUE, HOWEVER THE ROLE OF NEOADJUVANT A VERY CONTROVERSIAL ISSUE, HOWEVER THE ROLE OF NEOADJUVANT

THERAPY SEEMS TO BE BENEFICIAL. THERAPY SEEMS TO BE BENEFICIAL.

THEREFORE PRIOR TO PROCEEDING FOR EXCISION OF RECTAL CANCER THEREFORE PRIOR TO PROCEEDING FOR EXCISION OF RECTAL CANCER

A MULTIDISCIPLINARY APPROACH AMONG SURGEON, ONCOLOGIST, A MULTIDISCIPLINARY APPROACH AMONG SURGEON, ONCOLOGIST,

RADIOLOGIST AND PATHOLOGIST IS NEEDED IN ORDER TO SELECT THE Pts RADIOLOGIST AND PATHOLOGIST IS NEEDED IN ORDER TO SELECT THE Pts

AND CONSIDER THE RISK OF LOCAL RECURRENCES. AND CONSIDER THE RISK OF LOCAL RECURRENCES.

CONCLUSION 4CONCLUSION 4


a. montori m.d. f.a.c.s. professor of surgery university of rome “la sapienza” president of...

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