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94
M. R. Albert and P. Kaminsky
Management ofDefects After
Local Excision
Following TAMIS local excision, it is our practice to irrigate the defect with betadine to minimize bacteria and tumor contamination. Rectal
wall closure is then performed; full-thickness
defects are reapproximated transversely with
interrupted or continuous suturing to avoid narrowing the lumen. The pneumorectum is
decreased to 7–8mmHg to reduce tension on the
suture lines. A running closure beginning in the
lateral portion of the incision can be achieved but
is technically more challenging. The use of a
V-Loc™ suture (Covidien, Manseld, MA) or
other commercially available types of selflocking, barbed absorbable suture can expedite
continuous closure by maintaining tension and
negating the need for endoluminal knot tying
(Fig.9.6). Conversely, closure can be performed
in an interrupted fashion with knot tying facilitated by laparoscopic knot pushers. In some
cases, automated suturing devices– such as the
combination RD180/TK device (LSI Solutions,
Victor, NY) or the Endo Stitch™ suturing device
(Medtronic, Minneapolis, MN)– can be utilized
to expedite the closure process but may not be
available, and such devices increase per-case
costs as well.
Alternatively, defects which do not violate the
peritoneum can be left to heal with expectation of
a minimal scar within 4–6weeks and few complications. Hahnloser et al. reported outcomes
from 75 TAMIS excisions performed at three
centers and found no difference in complications
Fig. 9.6 Rectal wall defect being closed using continuous V-Loc suture
between closed defects and those that were left
open [15]. A rigid or exible sigmoidoscope can
be used to assess luminal diameter and patency, if
a concern about narrowing has been raised.
Conclusions
TAMIS relies on fundamental minimally invasive
surgical skill and equipment. With proper TAMIS
technique and for carefully selected patients,
high-quality local excision of rectal neoplasia is a
valid option with low morbidity that maintains
the advantages of organ preservation.
References
1. Clancy C, Burke JP, Albert MR, O’Connell PR,
Winter DC.Transanal endoscopic microsurgery versus standard transanal excision for the removal of rectal neoplasms: a systematic review and meta-analysis.
Dis Colon Rectum. 2015;58(2):254–61.
2. Kidane B, Chadi SA, Kanters S, Colquhoun PH, Ott
MC.Local resection compared with radical resection
in the treatment of T1N0M0 rectal adenocarcinoma:
a systematic review and meta-analysis. Dis Colon
Rectum. 2015;58(1):122–40.
3. Lu ZR, Rajendran N, Lynch AC, Heriot AG, Warrier
SK.Anastomotic leaks after restorative resections for
rectal cancer compromise cancer outcomes and survival. Dis Colon Rectum. 2016;59(3):236–44.
4. Glasgow SC, Bleier JI, Burgart LJ, Finne CO, Lowry
AC. Meta-analysis of histopathological features of
primary colorectal cancers that predict lymph node
metastases. J Gastrointest Surg. 2012;16(5):1019–28.
5. Saraste D, Gunnarsson U, Janson M. Predicting
lymph node metastases in early rectal cancer. Eur J
Cancer. 2013;49(5):1104–8.
6. Han J, Hur H, Min BS, Lee KY, Kim NK.Predictive
factors for lymph node metastasis in submucosal
invasive colorectal carcinoma: a new proposal of
depth of invasion for radical surgery. World J Surg.
2018;42:2635.
7. Oka S, Tanaka S, Nakadoi K, Kanao H, Chayama
K. Risk analysis of submucosal invasive rectal carcinomas for lymph node metastasis to expand indication criteria for endoscopic resection. Dig Endosc.
2013;25(Suppl 2):21–5.
8. Okabe S, Shia J, Nash G, Wong WD, Guillem JG,
Weiser MR, etal. Lymph node metastasis in T1 adenocarcinoma of the colon and rectum. J Gastrointest
Surg. 2004;8(8):1032–9; discussion 9–40
9. Nascimbeni R, Burgart LJ, Nivatvongs S, Larson
DR. Risk of lymph node metastasis in T1 carci-
9 Surgical Technique forLocal Excision ofRectal Neoplasia
95
noma of the colon and rectum. Dis Colon Rectum.
2002;45(2):200–6.
10. Bhangu A, Brown G, Nicholls RJ, Wong J, Darzi
A, Tekkis P.Survival outcome of local excision versus radical resection of colon or rectal carcinoma: a
Surveillance, Epidemiology, and End Results (SEER)
population-based study. Ann Surg. 2013;258(4):563–
9; discussion 9–71
11. Lu JY, Lin GL, Qiu HZ, Xiao Y, Wu B, Zhou
JL. Comparison of transanal endoscopic microsurgery and total mesorectal excision in the treatment
of T1 rectal cancer: a meta-analysis. PLoS One.
2015;10(10):e0141427.
12. Tranchart H, Lefevre JH, Svrcek M, Flejou JF,
Tiret E, Parc Y. What is the incidence of metastatic
lymph node involvement after signicant pathologic
response of primary tumor following neoadjuvant
treatment for locally advanced rectal cancer? Ann
Surg Oncol. 2013;20(5):1551–9.
13. Waheed A, Miles A, Kelly J, JRT M, Motl JS, Albert
M. Insufation stabilization bag (ISB): a costeffective approach for stable pneumorectum using a
modied CO2 insufation reservoir for TAMIS and
taTME. Tech Coloproctol. 2017;21(11):897–900.
https://doi.org/10.1007/s10151-017-1716-7. Epub
2017 Nov 14
14. deBeche-Adams T, Nassif G. Transanal minimally invasive surgery. Clin Colon Rectal Surg.
2015;28(3):176–80.
15. Hahnloser D, Cantero R, Salgado G, Dindo D, Rega
D, Delrio P. Transanal minimal invasive surgery for
rectal lesions: should the defect be closed? Color Dis.
2015;17(5):397–402.
Pyramidal Excision for Early Rectal Cancer and Special Closure Techniques
Giovanni Lezoche, Mario Guerrieri,
and Emanuele Lezoche
10
No other topic in general and colorectal surgery
has had similar dramatic changes such as the
therapy of low rectal cancer in the last two
decades. The changes are not only related to the
newminimally invasivetechnologies but also to
the doctrinal acceptance that more aggressive
surgery does not necessarily translate into
improved oncologic results applicable to all
stages rectal cancer. In other words, the same
revolution that occurred in the 1980s for breast
cancer is now in progress within the community
of colorectal surgeons. pyramidal excision (PE)
of rectal tumors is the counterpart of the
“lumpectomy” for breast cancer. The partial
removal of the rectum obtained by PE has relevant advantages when compared to TME in
terms of postoperative morbidity, mortality, and
functional sequelae.
Comparing PE with conventional local exci-
sion (LE), the main benet is represented by the
possibility of examining the locoregional nodes
in order to arrive at a more accurate tumor stage.
In this regard, it is useful to emphasize that for
rectal cancer (in the literature), there is no evidence of metastatic skip lesions in lymphatic
nodes. This observation has been noted in the
G. Lezoche · M. Guerrieri
Università Politecnica delle Marche, Ancona, Italy
E. Lezoche
Università di Roma “SAPIENZA”, Rome, Italy
(*)
case of histologically high-risk tumors, which are
not eligible for PEor other local procedures.
Furthermore, the full-thickness LE, which is
the most frequent operation reported in TEM&
TAMIS literature, does not permit examination
of the locoregional lymphatic stations. On the
contrary, PE performed by TEM/TAMIS allows
one to remove the locoregional nodes, and for
these reasons we have termed this endoluminal
locoregional resection (ELRR). In fact, the rationale of this operation is to remove (en bloc) the
lesion and all the surrounding tissue, performing
a wide round incision including a minimum of
1cm of normal mucosa. Radially, the rectal wall
and the mesorectum are excised to the level of the
“holy plane,” in order to obtain a surgical specimen in the shape of a pyramid, whose base is
very large and composed by the mesorectal fascia
(i.e., the circumferential deep diameter is greater
than the mucosal resection diameter).
Analyzing the papers that report the clinical
results of LE, it has been observed that in absence
of an internationally accepted denition, in the
majority of cases, the employed surgical technique is not sufciently described. Therefore, the
different results reported in terms of local recurrences can also be related to the differenttechniques applied towards LE. It is hoped that
Scientic Societies organize a Consensus
Conference to dene the terminology of the different local operations that can be performed to
treat rectal lesions through traditional surgery
© Springer Nature Switzerland AG 2019
S. Atallah (ed.), Transanal Minimally Invasive Surgery (TAMIS) and Transanal Total Mesorectal
Excision (taTME), https://doi.org/10.1007/978-3-030-11572-2_10
97
98
G. Lezoche et al.
and TEM/TAMIS.Propernomenclatureis often
not properly used, and this is claried in the following section.
Nomenclature: Excision versus Resection
The majority of medical terminology originates from ancient Greek and Latin. A paradigmatic example of misunderstanding semantics
is the operation described by Prof. RJ “Bill”
Heald in 1982, termed total mesorectal ‘excision’ (TME). Nowadays, the term TME is universally accepted despite the fact that it is a
contradiction in terms: in fact “excidere”
comes from the Latin language and is the union
of two terms “ex” and “cidere.” The term “ex”
has implicit the concept of a part of the whole
and “cidere” to cut. Consequently, the correct
meaning of “excidere” is to remove a part of
the whole. Therefore, in coining the name
“total mesorectal excision,” Bill Heald utilized
conicting terms that conveyed a meaning that
is quite opposite to the message intended.
On the other hand, the term “resection”
draws its origin from another Latin word that
likewise represents the synthesis of two different words: “re” and “secare.” “Re” plays the
role of strengthening the term “secare,” which
means to cut, with the nal meaning of to take
out the whole. Consequently the term “total
mesorectal resection” (and its acronym “TMR”)
seems to be more appropriate instead of “total
mesorectal excision” or TME.
Another matter of lexical confusion is the
term “local excision,” as in the majority of published research does not specify which extension
(depth) of tissue has been removed. To dene the
spatial model of the “LE” dissection, several
items should be characterized, as follows: (a) the
modality to assess tumor-free margins, (b) width
of free mucosa included in the circumferential
excisional margin, (c) depth of incision, (d) angle
(ordegree) of the lateral margin withrespect to
the mucosal surface, (e) depth of basal dissection,
as well as other factors. These data are important
elements to evaluate the amplitude and quality of
dissection.
Utilizing either TEM or TAMIS, it is possible
to follow ve different levels of dissection as
shown in Fig.10.1 and asdelineated below:
A. Submucosal dissection. This has the advan-
tage of removing “en bloc” the specimen
without violating the entire bowel wall and
is considered acceptable for benign neoplasia, especially large sessile polyps which are
more difcult to excise endoscopically.
B. Infra-muscle layer dissection. This proce-
dure requires high surgeon dexterity. Usually
it is performed only to remove large benign
Fig. 10.1 Five different
levels ofexcision
possible withTEMor
TAMIS
1 -Mucosectomy
2 –Inframuscular layers
excision
3 –Full thickness excis.
4 – Full thickness excis.
+ resection of upper part
of mesorectum
5 –ELRR: Endolumen
Loco-Regional Resection
TEM : 5 different levels of bottom xeresis
10 Pyramidal Excision for Early Rectal Cancer and Special Closure Techniques
99
polyps of the upper part of the rectum to
avoid intraperitoneal entry. Furthermore, in
case of at degenerative polyps, it allows the
morphologist to analyze cancer cell penetration into the submucosa space without thermal artefacts.
C. Full-thickness rectal wall excision. In this
technique, generally employed from the
majority of the authors and too often is
dened erroneously as a TEM procedure, the
entire rectal wall is excised circumferentially
including the neoplasm, with a typically recommended 1 cm minimal radial margin
(mucosal margin).
D. Full-thickness rectal wall removal combined
with the resection of the upper part of the
mesorectum. This follows the principles of
full-thickness local excision but also includes
a small portion of mesorectum underlying the
rectal wall.
E. Full-thickness rectal wall resection com-
bined with resection of all the mesorectum
adjacent to the tumor. In this case the resec-
tion reaches the lower level of the mesorectum, and the base dissection is performed
following the so-called holy plane, that is,
apyramidal local excision.
The possibility for the surgeon to choose so
many different levels of deep dissection during
the TEM (or TAMIS) procedure makes clear that
expressions, such as “the patient underwent
TEM,” are simply an insufcient descriptor.
Depth of excision, as well as the status of the
radial margins (including minimum distance of
normal mucosa to involved edge of tumor),
should be, but is not always, routinely described.
This is a likely factor contributing to the wide
variability among series when describing local
recurrence rates [1].
Rationale of Pyramidal Excision
Pyramidal excision(PE) is a full-thickness rectal
wall resection combined with resection of all the
mesorectum adjacent to the tumor and is synony-
mous with endoluminal locoregional resection
(ELRR). With this approach, the excised specimen resembles the shape of a pyramid. When
Gerard Buess, in the 1980s, introduced TEM into
clinical practice, the operation that he proposed
was a mucosectomy, or a partial-thickness excision of a portion of the rectal wall. During the
early 1990s, Buess subsequently adopted the
technique of ELRR.
It is intuitive that by removing a larger amount
of lymphatic tissue juxtaposed tothe tumor, the
risk of local recurrence could be is reduced.
While this is fundamental to the principles of en
bloc radical resection, whereby tumor resection
is predicated upon the vascular supply and draining lymph node basin. The same concept of
“removing more” is probably also applicable for
early-stage(T1) rectal cancers.
The assessment of tumor diffusion depth into
submucosa (Kikuchi Classication, sm1–sm3)
on the biopsies performed with exible endoscopy is not usually reliable. At the same time,
literature clearly demonstrated that sm1lesions
have a risk of nodal metastasis up to 3%; sm2
have a risk of 5–8%; and sm3 have a risk of
≥25%. Thus T1sm3 nodal metastatic risk is similar to that of T2 tumors [2]. Interestingly, T1sm3
tumors represent more than 40% of all cases [3].
The data and concepts presented thus far can
be surmised in the following key points:
• Full-thickness excision alone (without pyra-
midal excision) is likely an inadequate ther-
apy in the majority of T1 rectal cancer, except
for very well-selected, histologically favor-
able lesions.
• It is very important to perform multiple macro-
biopsies to assess preoperatively tumor depth
particularly to characterize T1 submucosal
penetration.
• As a signicant fraction of T1 rectal cancers
have a similar risk of lymphatic involvement
as T2 cancers, it is a not appropriate to treat T1
lesions (e.g., T1sm3) differently than T2
staged cancers. For these lesions, stan-
dardfull-thicknesslocal excision alone, in the
authors’ opinion, is insufcient and is more
likely to result in treatment failure than pyra-
midal excision.
100
Outcome of 3 different TEM procedures
G. Lezoche et al.
The inadequacy of conventional full-thickness local excision for T1 cancers is clearly
demonstrated by available data. In fact, the
percentages of recurrence in pT1 patients
reported by three institutions are signicantly
different. However, despite the utilization of
advanced instrumentation (TEM), the operations performed in each institution are heterogeneous, as illustrated in Fig.10.2. The Dutch
group [4] examined 88 pT1 treated with fullthickness localexcision and reported an unacceptably high recurrence rate of 20.5%.
Comparatively, other investigators [5] who
performed full-thickness excision combined
with the resection of the upper part of the mesorectum reported percentages of local recurrences
that were signicantly lower – approximately
12%– for 86 patients who underwent transanal
local excision for pT1 rectal cancer.
In our experience, ELRR utilizing the TEM
apparatus was successfully performed on 270
patientswith pT1 rectal cancer. On follow-up, the
local recurrence rate measured lessthan 3%.
The literature reports that administration of
neoadjuvant treatment (NT) reduces the risk of
local recurrence and probably increases survival
rate. According to the Dutch Trial (CKVO
95–04), radiotherapy reduces the percentage of
local recurrences by one-half (from 11.4 to
5.8%). These positive results combined with the
observation that after NT, the number of lymph
nodes detectable in the mesorectum is signicantly lower when compared with untreated
patients – suggesting that NT can also sterilize
metastatic lymphatic nodes.
Furthermore, NT has the advantage that it can
signicantly shrink the tumor mass, making local
excision more feasible; for this reason, standard
long-course radiotherapy is preferable to shortcourse XRT that is less effective in tumor mass
reduction.
On the bases of these clinical observations, a
protocol to treat small (diameter <3) iT2N0M0
rectal cancer performing ELRR after completion
of long-course therapy with 50.4 GY (lcNT)was
developed.
With encouraging clinical results as well as
conrmatory 5-year follow-up data, our center
developed a protocol for a prospective randomized trial on T2 rectal cancer, entitled the “Urbino
Trial”– named after the renaissance city where
the meeting to design this protocol was held. The
results of the Urbino Trial are detailed in the last
section of this chapter.
Fig. 10.2 Markedly
different rates of local
recurrence, based on
three differentlevels of
local excision
performedusing an
advanced transanal
platform
pT1 local recurrence
pT1 n.pts
Doornebosch et al. Dis Colon Rectum
2010
Stipa et al. Dis Colon Rectum 2012
lezoche
88 20.5
86 11.6
245 3.2
LR
%
20.5
11.6
2.96
10 Pyramidal Excision for Early Rectal Cancer and Special Closure Techniques
101
Patient Selection
Patient selection is fundamental. Although discussed elsewhere in this textbook, the protocol
followed at our center is briey delineated.
Index Staging (Pre-NT)
• Digital rectal examination (DRE). The xity
and the distance of the tumor margin from
the anal ring must be registered and documented by DRE. Sphincter tone must be
carefully assessed, and if indicated, formal
pelvic oor testing, including manometry,
should be performed to determine baseline
function.
• Flexible endoscopy and biopsy. It is advisable
to use dye to identify tumor limits especially
for at lesions or adenomas with ambiguous
margins. In our protocol it is always mandatory to take 5–6 biopsies, circumferential to
the tumor at 1cm distance from the lesion’s
perimeter, on what appears to be normal,
native rectal mucosa. Every biopsy must be
identied by a number corresponding the anatomic position and sent to pathology for careful histologic examination. The rationale for
this is to excludeor conrm the presence of
malignant histology.
• Tattooing. We consider it mandatory to per-
form tattooing at each biopsy site in order to
reduce the risk of an incomplete excision of
the lesion during ELRR. The excision line
must include all the tattoo spots to avoid this
and to assure tumor-free margins. Surprisingly,
incomplete local excisions are not infrequently reported and measure as high as 22%
in some series [1]. In this regard, it is crucial
to understand that after NT, the tumor borders
are generally not clearly identiable.
Furthermore, when the tumor is downsized
from the effect of NT, clusters of neoplastic
cells can still be identied in the area where
the cancer was present prior to treatmentinduced regression. The meaning and the evolution of these persistent neoplastic cell
clusters remain elusive; therefore prudentially,
in our protocol, we consider it mandatory to
remove all the area where the neoplasia was
located prior to NT.
• Rigid rectoscopy is extremely useful in identifying circumferential tumor location (i.e.,
anterior vs. posterior, right or left lateral) and
consequently the appropriate patient position
on the operative table, which is relevant for
the rigid TEM scope (with the TAMIS technique, patients can be positioned dorsal lithotomy for the vast majority of lesions, but
information from rigid proctoscopy is still
invaluable).
• Macro-biopsies. Utilizing the rigid rectosigmoidoscope, it is possible to perform macrobiopsies using the conventional forceps
(Fig.10.3) that can remove a substantial
amount of tissue, allowing pathologists to better assess the histological tumor grade and, in
case of T1 cancers, a correct sm depth assessment which is critical to determining the optimal therapeutic strategy.
• Imaging. Advancements in magnetic reso-
nance imaging (MRI) including stronger
magnets (3-Tesla), diffusion-weighted imaging, and new MRI-compatible contrast agents
have signicantly improved the diagnosis of
metastatic nodes (N) and the more precise
tumor (T) stage. It is our preference to perform rectal protocol MRI for all stages of rectal cancer.
Endorectal ultrasound (EUS) is useful to dif-
ferentiate T1 vs. T2 but is unable to evaluate the
submucosal inltration despite the remarkable
technological improvement of 3D ultrasound
instrumentation. Therefore, macro-biopsies
Fig. 10.3 Conventional forceps for “macro-biopsies”
102
TME : Morbidity & Mortality
•
•
•
•
(Data from litterature
)
G. Lezoche et al.
remain thepreferred method to evaluate submucosal inltration. Furthermore, surgeons who
perform EUS have the advantage of acquiring in
their mind the virtual spatial reconstruction of the
lesion with its anatomic location, extension, and
limits. All this allows one to perform a surgical
dissection following optimal plans to obtain a
pyramidal shaped specimen containing the tumor,
with equidistant free margins.
PET-CT. This imaging modality has no proven
diagnostic value for the staging of rectal cancer.
When performed after ELRR, it may result in
false positive results, which can be caused by the
long process of healing required for some large
defects created during the process of pyramidal
excision. Therefore, when PET-CT is used, it is
recommended to not be performed prior to
9months post-ELRR.
• Anal Sphincter Manometry. Preoperative
assessment of sphincter function is advisable
in patients with low-lying rectal cancer, in all
elderly subjects, and/or in patients with
reduced sphincter tone.
• Quality of Life Forms. All patients should
complete a specic quality of life (QoF)
forms (C39 and C38): upon diagnosis and
prior to surgical intervention; the assessment
is ideally completed at 6, 12, and 24months
after ELRR.
by utilizing a local procedure (namely PE)
rather than radical resection for several reasons. First, TME, even with the advent of less
invasive (laparoscopic/robotic) techniques,
maintains the same risk of morbidity and mortality unmodied from open techniques.
Second, postoperative urinary, sexual, and
bowel dysfunctions are very high (Fig.10.4).
Last but not least, quality of life is strongly
compromised by stoma creation (even when
constructed for temporary fecal stream diversion). In Mediterranean countries, patients
(and their treating surgeons) generally try to
avoid stomas, even if it is temporary.This is
particularly important for specic cultures and
locales[6] Fig.10.5.
For these reasons, in the past decades, many
surgeons, to avoid the postoperative risk of
TME, have preferred to perform unstandardized local excision despite the disappointing
high percentage of local recurrence. According
to the data from the US National Cancer
Database (NCDB), the local excision rate from
the 1990s to the beginning of this century doubled for T1 and tripled for T2, as shown in
Fig.10.6.
Combining conventionalLE with NT does
not signicantly increase the clinical results in
terms of local recurrences (Fig.10.7) and prob-
Neoadjuvant Therapy (NT)
NT is generally considered mandatory for
advanced tumors. However, in recent years the
realization that early T-stage rectal cancer (e.g.,
T1sm3 and T2) can harbor occult metastatic
nodes has improved our understanding of the
possible effect of full-dose NT (fdNT) in treating
the draining lymph node basins. Coupled with
the favorable clinical results observed with ELRR
for such lesions, the addition of fdNT for nonadvanced, select rectal cancer has provided
improved cure rates.
At our center, the preferential surgical
option for treating early-stage rectal cancer is
Morbidity 20–30%
Mortality 2–5%
in high risk pts ~ 10%
Local recurrence 5–15%
Metastatic disease > 30%
Funtional sequalae
• Urinary dysfunctions 10%
• Sexual dysfuntions 13–70%
• Anastomotic leaks 5–17%
• Definitive colostomy 10–15%
• Temporary oostomy 20–100%
Fig. 10.4 Morbidity, mortality, and functional sequelae
of TME according to the data from literature
10
20
30
40
50
60
70
Praying alone Fast in ramadan
Stoma acceptance
10
15
20
25
30
35
40
45
T1
T2
USA NATIONAL CANCER DATA BASE
Local recurrence rate after transanal excision
10 Pyramidal Excision for Early Rectal Cancer and Special Closure Techniques
Fig. 10.5 The stoma
acceptance is strictly
Strictly related to the geografic area
related to the geographic
area. In Mediterranean
countries, it is not
infrequent that patient
refuses operation for the
risk of stoma. (Kuzu
etal. [6]. https://link.
springer.com/
article/10.1007/
s10350-004-6425-4.
Data only)
0
Praying in mosque
103
1989-2003 Local Excision rate for Rectal Cancer
5
0
(sample 2124 pts: L.E. 765)
1989 2003
Fig. 10.6 Number of local excision performed in the
USA in 1989 and 2003 for T1 and T2 rectal cancer
T1
(Surgery + Pre/PostOp. Adjuvant Therapy)
N. Loc. Rec.
Benoist et al. 1998 30 13
Baron et al. 1995 91 21
Read et al.1995 22 9.1
Willet et al. 1994 46 18
Rounet et al. 1993 18 11
Bailey et al. 1992 53 8
DeCosse et al. 1989 57 NS
Fig. 10.7 Combining conventional, full- thickness LE
with NT does not signicantly increase local recurrences
T2
ably survival rate. These data are anotherindication that the clinical results of local treatment
depend on complete tumor excision with negative margins (R0) and, in addition, the complete removal of the lymphatic tissue
surroundingthe segment of bowel containing
the neoplasm.
104
G. Lezoche et al.
Patients’ Eligibility for ELRR (Pyramidal Local Excision)
Basic Exclusion Criteria
1. Histologically high-risk tumors (undifferentiated and mucous histology).
2. Tumors with highly suspicious metastatic
lymph nodes (identied on imaging before
initiation of NT).
3. Tumors with lymphatic, neuronal, and vessel
inltration (not responsive to NT).
4. T4 cancers.
5. T2 and T3 cancers which are not responsive to
NT.
cT1
cT1 Inclusion Criteria:
• sm1 and sm2: without histological high-risk
features,
• Rectal ProtocolMRI negative nodes, diameter
<5mm, iso-echogenic, with smooth, regular
shape.
• Located in the extraperitoneal rectum.
• cT1sm3, treated with NT.
cT1 Exclusion Criteria:
• sm3, in patients refusing NT,
• Tumor located mainly in the intraperitoneal
rectum.
• Mucinous or undifferentiated cancer.
• Patient refusing close follow-up and informed
consent.
• Imaging suspicious for nodal disease.
cT2
cT2 Inclusion Criteria:
• Patients who completed NT with a good
response (downstaged >50%).
• Tumor diameter <4cm.
• Tumor located in the extraperitoneal rectum.
• MR- and CT-negative nodes (<5 mm, isoechogenic, non-spiculated appearance).
• Tumor is non-xed (mobile on palpation).
• Patient accepting close follow-up and
informed consent.
cT2 Exclusion Criteria:
• Non-responders to NT: Tumor mass reduction
<50%.
• High undifferentiated or mucous rectal
cancer.
• Tumor diameter >4cm after NT.
• Tumor located in the intraperitoneal rectum.
• MR and CT imaging suspicious nodes (>5mm,
not iso-echogenic, irregular shape) after NT.
• Tumor is xed (nonmobile by palpation).
• Patient refuses to accept a program of close
follow-up and informed consent.
cT3
cT3 Inclusion Criteria:
• High-risk patients: age over 80 yo, comorbid
conditions (ASA 3 or 4), and/or patients who
refuse permanent or temporary stoma.
• Patients who underwent NT with good
response (downstaged >50%).
• Tumor diameter <4cm.
• Tumor located in the extraperitoneal rectum.
• MR- and CT-negative nodes (<5 mm, isoechogenic, regular shape).
• Tumor is non-xed (mobile on palpation).
• Patient accepting close follow-up and
informed consent.
cT3 Exclusion Criteria:
• Non-responders to NT: Tumor mass reduction
<50%.
• High undifferentiated or mucinous rectal
cancer.
• Tumor diameter >4cm.
• Tumor located in the intraperitoneal rectum.
• MR and CT imaging reveal suspicious nodes
(>5 mm, not iso-echogenic, irregular shape)
after NT.
• Tumor is xed.
• Patient refuses to accept a program of close
follow-up and informed consent.
Informed Consent
The informed consent form will include all the
possible options possible in relation to the