Beyond the EU: DORA and NIS 2 Directive's Global Impact
Lo stent nelle occlusioni neoplastiche del Colon - Gastrolearning®
1. Lo Stent nelle
Occlusioni Neoplastiche
del Colon
Guido Costamagna
Catholic University – “A. Gemelli” Hospital
European Endoscopy Training Center (EETC)
Rome - Italy
3. 1991: Esophageal Stents sporadically
used for palliation in CRC obstruction
1991
First (esophageal) stent
implantation
for palliative treatment
Dohmoto M, Rupp KD (1991)
Dtsch Med Wochenschr 115: 943
7. Indications
to Colorectal Stents
Bridge to Surgery
Acute colonic obstruction
Palliation
CR cancer stage IV patients
Unresectable extracolonic neoplasms
Patients unfit for surgery
Patients who refuse colostomy
8. Literature on CRC and Stents
Multiple retrospective studies
Variability in case-mix
Selection biases
Shortcomings of the published literature
Vast heterogeneity in the technical
success rates and risk profiles
5 RCT’s
11. Bridge-to-Surgery
Rationale
To avoid emergency surgery
Allow normal preoperative bowel preparation
followed by a one-stage elective procedure
Allows time for resuscitation, re-hydration, and
hyper-alimentation
To decrease the rate of stoma formation
Overall lower morbidity and mortality
If Stage IV Palliation
12. Bridge-to-Surgery
Emergency
surgery
vs
Elective
surgery
Morbidity 10% - 36%
Morbidity 4% - 14%
Mortality 6% - 38%
Mortality 1% - 13%
Often 2-stage procedure with
temporary colostomy
Colostomy reversal only in 60%
Colostomy associated with
morbidity and QoL implications
Data from Literature
13. Malignant Colonic Obstruction:
Literature Review on CR Stents
(1992-2004)
54 Series*
1198 Pts
Palliation
Bridge to Surgery
791 (66%)
407 (34%)
* Technique:
Endo-Rx
Rx
Endo
37
16
1
Sebastian. Am J Gastroenterol 2004; 99: 2051-57
14. Literature Review on Bridge to Surgey
Technical Success
91.9%
Clinical Success
78.1%*
*Causes of clinical failure:
• Locally advanced tumor
• Poor preparation
• Stent migration
• Perforation
Am J Gastroenterol 2004
15. Bridge to Surgery vs Emergency Surgery:
Long-Term Prognosis
Early complications
14%
12%
10%
P<0.05
8%
Emerg. Surg.
Stent
6%
4%
2%
0%
Infections
Anast. Leak
Saida et Al. Dis Colon Rectum 2003
16. Bridge to Surgery vs Emergency Surgery:
Long-Term Prognosis
Survival rate
40%
5 years
fu
44%
48%
3 years
0%
Emerg. Surg.
Stent
50%
20%
40%
60%
Saida et Al. Dis Colon Rectum 2003
17. Cost Analysis of
Bridge to surgery
vs 2-stage surgical procedure
6000
Cost in GBP (£)
5000
Bridge to surgery
and elective resection
(n=5)
4000
3000
Hartmann’s operation
and reversal
(n = 6)
2000
1000
0
Hospital Stent
stay
Material Theatre/
(excl. radiology
stent)
suite
Total
Osman H.S. et al. Colorectal Dis 2000
18. 2002: A role for Lap Surg
Malignant colonic obstruction managed by
endoscopic stent decompression
followed by laparoscopic resection
Morino et Al. Surg Endosc 2002
21. Effect of primary tumor resection on
survival in CRC stage IV Patients
Palliative Surgery vs CR Stenting
Palliative resection of primary CRC
should be pursued in stage IV patients,
as this prolongs survival
In these pts new schedules of chemotherapy
has improved the median survival
from around 11 months with conventional regimes
to over 20 months with the new ones
Cochrane Database Syst Rev 2000
Costi R et al. Ann Surg Oncol 2007
Konyalian VR et al. Colorectal Dis 2007
23. Stents for
Colonic vs Extracolonic Malignancy
Colon stenting for large-bowel obstruction from
ECM is seldom successful and is associated
with a significantly higher risk of complications in
comparison with patients with CRC
Keswani RN. Gastrointest Endosc 2009
25. Malignant Colonic Obstruction:
Literature Review on CR Stents
Complications
Stent Migration
11.8%
Re-obstruction
7.3%
Perforation
3.7%
Mortality
0.6%
Am J Gastroenterol 2004
26. Colonic perforation after stent placement for malignant
colorectal obstruction – causes and contributing factors
Datye A, Hersh J. Minim Invasive Ther Allied Technol. 2011
2287 pts from 82 articles
Overall perforation rate: 4.9%
Perf rates for P and BTS not significantly different
(4.8% vs. 5.4%, p = 0.66);
Over 80% of perf occurred within 30 days of stent
placement
Mortality rate related to perforation: 0.8%
Mortality of patients with perforation: 16.2%.
No significant difference (p = 0.78) in the mortality
rates between the P and the BTS group
27.
28. Premature Closure of the
Dutch Stent-in I Study
Multi -centre, prospective, randomised
controlled trial WallFlex stent VS surgery
in patients with incurable CRC
Study stopped by the Safety Monitoring Committee
21 patients included.
10 patients treated with stenting.
Hooft EJ and Dutch Stent-in Study Group. Endoscopy 2008
29. Premature Closure of the
Dutch Stent-in I Study
60% Perforation Rate !
Hooft EJ and Dutch Stent-in Study Group. Lancet 2006
30. Premature Closure of the
Dutch Stent-in I Study
Of the seven stented patients who were treated
with chemotherapy, four developed a (late) perforation
Hooft EJ and Dutch Stent-in Study Group. Lancet 2006
31. The 11.1% mortality following colonic stenting
for obstructing cancers
was higher than in published cases
and may need further study
The Association of Coloproctology of Great Britain and Ireland
32. Palliative SEMS:
Look Out for Perforations !
3/19 pts (16%)
died within a week after the insertion
of an Ultraflex Precision Stent
Surg Laparosc Endosc Percutan Tech, 2008
33. CR stents in palliative situation
Complications rates*: 25 - 50 %
Perforation :
Obstruction :
Migration :
5-20 %
5-10 %
Ulceration :
<5%
10-15 %
* 50% of complications are observed after the 1st week
Ceze, JFHOD 2007
Fernandez-Esparrach, Am J Gastro 2010
Small, GIE 2011
34. CR Stents: Risk of Perforation
Risk factors for perforation
Chemotherapy
Steroids
Radiotherapy
Datye A, Hersh J. Minim Invasive Ther Allied Technol. 2011
35.
36. Stents vs Surgery: 5 RCT’s
van Hooft JE
Lancet 2006
van Hooft JE
Lancet Oncology 2011
Pirlet IA
Surgical Endoscopy 2011
Alcántara M
World Journal of Surgery 2011
Ho KS
International Journal of Colorectal Disease 2012
37. Stents vs Surgery: 5 RCT’s
Four were interrupted by the respective
ethics committee:
One for the high incidence of perforations
(6/11)
Other two for the high perforation rate (13%
and 6.6%), and for the lack of benefit with
regard to quality of life and stoma formation.
Only the Study of Alcantara has been
discontinued for the high rate of anastomotic
dehiscence in one-stage surgery
38. … consider placing a SEMS
to initially manage a left-sided
complete or near-complete
colonic obstruction
Only a healthcare
professional experienced in
placing colonic stents who
has access to fluoroscopic
equipment and trained
support staff should insert
colonic stents
If a SEMS is suitable attempt
insertion urgently and no
longer than 24 hours after
patients present with colonic
obstruction.
39. • Systematic review of five RCTs
• Higher rates of clinical relief of obstruction in
emergency surgery
• CR stent has not been shown to be as effective as
emergency surgery in malignant colorectal
obstructions
• Use of CR stent is associated with comparable
mortality and morbidity with advantage of shorter
hospital stay and procedure time and less blood loss.
“Colonic stenting has no decisive advantages
to Emergency surgery”
Sagar Jayesh
Colorectal stents for the management of malignant colonic obstructions
39
Cochrane Database of Systematic Reviews. 2011
40. UK ColoRectal Stenting Trial (CReST)
2009 –
Pts in emergency setting
with left-sided neoplastic colonic obstruction
who require urgent decompression
Randomised to
Stenting
Stenting
Surgical decompression
Surgical decompression
+/+/Resection
Resection
41. To Stent or Not to Stent
That Is the Question
The question of stenting, therefore, remains
unanswered.
It seems a reasonable approach for patients with
incurable cancer who have a left-sided obstruction
or those who are not fit for an operation.
Questions arise as to the need for stents as a
bridge to surgical intervention given the high rate of
stoma formation despite decompression with a
stent.
Any risk of perforation in a patient with a potentially
curable obstruction is not acceptable because it
converts a curable obstruction into one destined for
42. Possible worsening of QoL
even after a successful SEMS insertion
… An elderly woman who presented with an
obstructing metastatic rectal cancer
underwent ‘successful’ insertion of SEMS and
was subsequently managed by the palliative
care team.
She died peacefully after 6 months …
The twist of the story was that she spent her
remaining days mostly on the toilet as the
stent made her incontinent…
D. Debnath. Br J Surg 2004
43. Stent Palliation of
Malignant Colonic Obstruction
Bowel function is often poor in patients
treated with CR stents
Functional outcome should be
discussed fully during the consenting
process for the procedure.
Colorectal Disease 2006, 7
44.
45. Contraindications
to Colorectal Stents
Long Life Expectancy
Right sided occlusions
Incomplete occlusion
Cancers ≤ 5 cm from the anal verge
Severe anemia by bleeding cancers
(Extracolonic Malignancies)
46. • The decision to insert a SEMS or to perform a
colostomy involves multiple areas of uncertainty…
• The longer a SEMS remains in place, the
greater the amount of uncertainty surrounding its
effectiveness and the higher the probability that
surgery is the preferred alternative
da Silveira E, Barkun AN.
Gastrointest Endosc. 2008.
47. • Utilization of SEMS for conditions that have not
been thoroughly investigated (ie, long-term
palliation of CRC) cannot be recommended yet ...
• … but short ‘‘bridges’’ from acute obstruction to
surgery can be safely ‘‘crossed’’ with the
endoscopic insertion of a colonic SEMS
da Silveira E, Barkun AN.
Gastrointest Endosc. 2008.
48. Stent Palliation of
Malignant Colonic Obstruction
Take Home Messages
Acute Occlusion = Bridge to Surgery
Palliation: Stent only if occlusion
If CT planned, consider resection
Discuss with the patient
(Informed Consent)
!
Notes de l'éditeur
Cumulative incidence of hospitalization for bowel obstruction over time in the baseline cohort of 12 553 patients with stage IV colon cancer in the Surveillance, Epidemiology, and End Results and Medicare claims linked databases for January 1, 1991, through December 31, 2005, stratified by tumor histological type. For reference, the median survival of each group is given. We found no significant difference in survival experience by histological type (P = .29) in a multivariable model of survival since the cancer diagnosis that included age at and year of diagnosis, sex, marital status, patient comorbidity score, primary tumor surgery, chemotherapy after diagnosis, tumor site and grade, and lymph node status. IQR indicates interquartile range.