Lo Stent nelle Lo Stent nelle Occlusioni NeoplasticheOcclusioni Neoplastichedel Colondel Colon

Guido CostamagnaGuido CostamagnaCatholic University – “A. Gemelli” HospitalCatholic University – “A. Gemelli” Hospital

European Endoscopy Training Center (EETC)European Endoscopy Training Center (EETC)

Rome - ItalyRome - Italy

Colorectal CancerColorectal Cancer

PresentingPresenting

symptom insymptom in

8-29%8-29% of cases of cases

ObstructionObstruction

1991 1991

First (esophageal) stentFirst (esophageal) stent

implantation implantation

for palliative treatment for palliative treatment

1991: Esophageal Stents sporadically 1991: Esophageal Stents sporadically used for palliation in CRC obstruction used for palliation in CRC obstruction

Dohmoto M, Rupp KD (1991) Dohmoto M, Rupp KD (1991) Dtsch Med Wochenschr 115: 943Dtsch Med Wochenschr 115: 943

Esophageal vs Colorectal Esophageal vs Colorectal Wall ThicknessWall Thickness

5-6 mm5-6 mm

3-4 mm3-4 mm

Esophageal vs Colorectal Esophageal vs Colorectal LumenLumen

2000: Specifically designed2000: Specifically designedColorectal StentsColorectal Stents

Indications Indications to Colorectal Stentsto Colorectal Stents

Bridge to SurgeryBridge to Surgery Acute colonic obstructionAcute colonic obstruction

PalliationPalliation CR cancer stage IV patientsCR cancer stage IV patients Unresectable extracolonic neoplasmsUnresectable extracolonic neoplasms Patients unfit for surgeryPatients unfit for surgery Patients who refuse colostomyPatients who refuse colostomy

Literature on CRC and StentsLiterature on CRC and Stents

Multiple retrospective studiesMultiple retrospective studies Shortcomings of the published literatureShortcomings of the published literature Variability in case-mix Variability in case-mix Selection biasesSelection biases Vast heterogeneity in the technical Vast heterogeneity in the technical

success rates and risk profilessuccess rates and risk profiles

5 RCT’s5 RCT’s

CRC and Stents in 2013CRC and Stents in 2013

Still No Evidence Based !Still No Evidence Based !

Endoscopic TreatmentEndoscopic Treatmentof Advanced CR Carcinomaof Advanced CR Carcinoma

Bridge-to-SurgeryBridge-to-Surgery

Bridge-to-SurgeryBridge-to-Surgery

To avoid emergency surgeryTo avoid emergency surgery Allow normal preoperative bowel preparation Allow normal preoperative bowel preparation

followed by a one-stage elective procedurefollowed by a one-stage elective procedure Allows time for resuscitation, re-hydration, and Allows time for resuscitation, re-hydration, and

hyper-alimentationhyper-alimentation To decrease the rate of stoma formationTo decrease the rate of stoma formation Overall lower morbidity and mortalityOverall lower morbidity and mortality

If Stage IV If Stage IV Palliation Palliation

RationaleRationale

Bridge-to-SurgeryBridge-to-Surgery

Morbidity 10% - 36%Morbidity 10% - 36%

Mortality 6% - 38%Mortality 6% - 38%

Often 2-stage procedure with Often 2-stage procedure with temporary colostomytemporary colostomy

Colostomy reversal only in 60%Colostomy reversal only in 60%

Colostomy associated with Colostomy associated with morbidity and QoL implicationsmorbidity and QoL implications

Emergency Emergency surgerysurgery

Elective Elective surgerysurgery

Morbidity 4% - 14%Morbidity 4% - 14%

Mortality 1% - 13%Mortality 1% - 13%

vsvs

Data from LiteratureData from Literature

54 Series*54 Series*1198 Pts1198 Pts

Malignant Colonic Obstruction:Malignant Colonic Obstruction:Literature Review on CR StentsLiterature Review on CR Stents

Sebastian. Am J Gastroenterol 2004; 99: 2051-57Sebastian. Am J Gastroenterol 2004; 99: 2051-57

(1992-2004)(1992-2004)

PalliationPalliation

791 (66%)791 (66%)

Bridge to SurgeryBridge to Surgery

407 (34%)407 (34%)

* Technique:* Technique:Endo-RxEndo-Rx 3737RxRx 1616EndoEndo 1 1

Technical SuccessTechnical Success91.9%91.9%

Clinical SuccessClinical Success78.1%*78.1%*

Literature Review on Bridge to SurgeyLiterature Review on Bridge to Surgey

Am J Gastroenterol 2004Am J Gastroenterol 2004

**Causes of clinical failure:Causes of clinical failure:• Locally advanced tumorLocally advanced tumor• Poor preparationPoor preparation• Stent migrationStent migration• PerforationPerforation

Bridge to Surgery vs Emergency Surgery:Bridge to Surgery vs Emergency Surgery: Long-Term Prognosis Long-Term Prognosis

0%

2%

4%

6%

8%

10%

12%

14%

Infections Anast. Leak

Emerg. Surg.

Stent

P<0.05

Early complicationsEarly complications

Saida et Al. Dis Colon Rectum 2003 Saida et Al. Dis Colon Rectum 2003

50%

48%

44%

40%

0% 20% 40% 60%

3 years

5 yearsfu

Emerg. Surg.

Stent

Survival rateSurvival rate

Saida et Al. Dis Colon Rectum 2003 Saida et Al. Dis Colon Rectum 2003

Bridge to Surgery vs Emergency Surgery:Bridge to Surgery vs Emergency Surgery: Long-Term Prognosis Long-Term Prognosis

Cost Analysis ofCost Analysis ofBridge to surgery Bridge to surgery

vs 2-stage surgical procedurevs 2-stage surgical procedure

0

1000

2000

3000

4000

5000

6000

StentStent Theatre/ Theatre/ radiology radiology

suite suite

Hospital Hospital staystay

TotalTotalMaterial Material (excl. (excl. stent)stent)

Bridge to surgery Bridge to surgery and elective resectionand elective resection

(n=5)(n=5)

Hartmann’s operation Hartmann’s operation and reversaland reversal

(n = 6)(n = 6)

Co

st

in G

BP

(£

)C

os

t in

GB

P (

£)

Osman H.S. et al. Colorectal Dis 2000Osman H.S. et al. Colorectal Dis 2000

Morino et Al. Surg Endosc 2002Morino et Al. Surg Endosc 2002

2002: A role for Lap Surg2002: A role for Lap Surg

Malignant colonic obstruction managed by Malignant colonic obstruction managed by endoscopic stent decompression endoscopic stent decompression followed by laparoscopic resectionfollowed by laparoscopic resection

Endoscopic TreatmentEndoscopic Treatmentof Advanced CR Carcinomaof Advanced CR Carcinoma

PalliationPalliation

Copyright © 2012 American Medical Association. All rights reserved.

From: Incidence and Predictors of Bowel Obstruction in Elderly Patients With Stage IV Colon Cancer:  A Population-Based Cohort Study

JAMA Surg. 2013;148(8):715-722. doi:10.1001/jamasurg.2013.1

Effect of primary tumor resection on Effect of primary tumor resection on survival in survival in CRC stage IV PatientsCRC stage IV Patients

Cochrane Database Syst Rev 2000Cochrane Database Syst Rev 2000Costi R et al. Ann Surg Oncol 2007Costi R et al. Ann Surg Oncol 2007

Konyalian VR et al. Colorectal Dis 2007Konyalian VR et al. Colorectal Dis 2007

Palliative Surgery vs CR StentingPalliative Surgery vs CR Stenting

Palliative resection of primary CRC Palliative resection of primary CRC should be pursued in stage IV patients, should be pursued in stage IV patients,

as this prolongs survivalas this prolongs survival

In these pts new schedules of chemotherapy In these pts new schedules of chemotherapy has improved the median survivalhas improved the median survival

from around 11 months with conventional regimesfrom around 11 months with conventional regimesto over 20 months with the new onesto over 20 months with the new ones

Technical SuccessTechnical Success93.2%93.2%

Malignant Colonic Obstruction:Malignant Colonic Obstruction:Literature Review on CR StentsLiterature Review on CR Stents

CR tumors93.5%

Extrinsic group78%

Am J Gastroenterol 2004; 99: 2051-57Am J Gastroenterol 2004; 99: 2051-57

Stents for Stents for Colonic vs Extracolonic MalignancyColonic 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

Clinical SuccessClinical Success88.5%88.5%

Malignant Colonic Obstruction:Malignant Colonic Obstruction:Literature Review on CR StentsLiterature Review on CR Stents

Am J Gastroenterol 2004; 99: 2051-57Am J Gastroenterol 2004; 99: 2051-57

ComplicationsComplications

Stent MigrationStent Migration 11.8%11.8%

Re-obstructionRe-obstruction 7.3% 7.3%

PerforationPerforation 3.7% 3.7%

MortalityMortality 0.6% 0.6%

Malignant Colonic Obstruction:Malignant Colonic Obstruction:Literature Review on CR StentsLiterature Review on CR Stents

Am J Gastroenterol 2004Am J Gastroenterol 2004

Colonic perforation after stent placement for malignant Colonic perforation after stent placement for malignant colorectal obstruction – causes and contributing factorscolorectal obstruction – causes and contributing factors

Datye A, Hersh J. Minim Invasive Ther Allied Technol. 2011Datye A, Hersh J. Minim Invasive Ther Allied Technol. 2011

2287 pts from 82 articles 2287 pts from 82 articles Overall perforation rate: 4.9%Overall perforation rate: 4.9%Perf rates for P and BTS not significantly different Perf rates for P and BTS not significantly different (4.8% vs. 5.4%, p = 0.66); (4.8% vs. 5.4%, p = 0.66); Over 80% of perf occurred within 30 days of stent Over 80% of perf occurred within 30 days of stent placement placement Mortality rate related to perforation: 0.8% Mortality rate related to perforation: 0.8% Mortality of patients with perforation: 16.2%.Mortality of patients with perforation: 16.2%.No significant difference (p = 0.78) in the mortality No significant difference (p = 0.78) in the mortality rates between the P and the BTS group rates between the P and the BTS group

Premature Closure of thePremature Closure of theDutch Stent-in I StudyDutch Stent-in I Study

Multi -centre, prospective, randomised Multi -centre, prospective, randomised controlled trial controlled trial WallFlex stent VS surgeryWallFlex stent VS surgery

in patients with incurable CRCin patients with incurable CRC

Study stopped by the Safety Monitoring CommitteeStudy stopped by the Safety Monitoring Committee21 patients included. 21 patients included.

10 patients treated with stenting10 patients treated with stenting. .

Hooft EJ and Dutch Stent-in Study Group. Endoscopy 2008Hooft EJ and Dutch Stent-in Study Group. Endoscopy 2008

Premature Closure of thePremature Closure of theDutch Stent-in I StudyDutch Stent-in I Study

Hooft EJ and Dutch Stent-in Study Group. Lancet 2006Hooft EJ and Dutch Stent-in Study Group. Lancet 2006

60% Perforation Rate !60% Perforation Rate !

Premature Closure of thePremature Closure of theDutch Stent-in I StudyDutch Stent-in I Study

Hooft EJ and Dutch Stent-in Study Group. Lancet 2006Hooft EJ and Dutch Stent-in Study Group. Lancet 2006

Of the seven stented patients who were treatedOf the seven stented patients who were treatedwith with chemotherapychemotherapy, four developed a (late) perforation, four developed a (late) perforation

The The 11.1%11.1% mortality following colonic stenting for mortality following colonic stenting for obstructing cancersobstructing cancers

was higher than in published cases was higher than in published cases

and may need further studyand may need further study

The Association of Coloproctology of Great Britain and Ireland The Association of Coloproctology of Great Britain and Ireland

Palliative SEMS:Palliative SEMS:Look Out for Perforations !Look Out for Perforations !

3/19 pts (3/19 pts (16%16%) )

died within a week after the insertion died within a week after the insertion

of an Ultraflex Precision Stentof an Ultraflex Precision Stent

Surg Laparosc Endosc Percutan Tech, 2008Surg Laparosc Endosc Percutan Tech, 2008

CR stents in palliative situationCR stents in palliative situation

Complications rates*: 25 - 50 %Complications rates*: 25 - 50 %

Perforation : Perforation : 5-10 %5-10 %

Obstruction : Obstruction : 10-15 %10-15 %

Migration : Migration : 5-20 %5-20 %

Ulceration : Ulceration : < 5 %< 5 %

Ceze, JFHOD 2007Ceze, JFHOD 2007Fernandez-Esparrach, Am J Gastro 2010 Fernandez-Esparrach, Am J Gastro 2010

Small, GIE 2011Small, GIE 2011

* 50% of complications are observed after the 1st week

CR Stents: Risk of PerforationCR Stents: Risk of Perforation

ChemotherapyChemotherapy

SteroidsSteroids

Radiotherapy Radiotherapy

Risk factors for perforationRisk factors for perforation

Datye A, Hersh J. Minim Invasive Ther Allied Technol. 2011

van Hooft JE Lancet 2006

van Hooft JE Lancet Oncology 2011

Pirlet IA Surgical Endoscopy 2011

Alcantara M World Journal of Surgery 2011

Ho KS International Journal of Colorectal Disease 2012

Stents vs Surgery: 5 RCT’sStents vs Surgery: 5 RCT’s

Stents vs Surgery: 5 RCT’sStents vs Surgery: 5 RCT’s

Four were interrupted by the respective ethics Four were interrupted by the respective ethics committee:committee: One for the high incidence of perforations (6/11)One for the high incidence of perforations (6/11) Other two for the high perforation rate (13% and Other two for the high perforation rate (13% and

6.6%), and for the lack of benefit with regard to quality 6.6%), and for the lack of benefit with regard to quality of life and stoma formation.of life and stoma formation.

Only the Study of Alcantara has been discontinued Only the Study of Alcantara has been discontinued for the high rate of anastomotic dehiscence in one-for the high rate of anastomotic dehiscence in one-stage surgerystage surgery

… 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.

• 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 JayeshColorectal stents for the management of malignant colonic obstructions

Cochrane Database of Systematic Reviews. 201139

UK ColoRectal Stenting Trial (CReST)UK ColoRectal Stenting Trial (CReST)2009 – 2009 –

Pts in emergency setting Pts in emergency setting with with left-sided left-sided neoplastic colonic obstruction neoplastic colonic obstruction who require urgent decompressionwho require urgent decompression

Randomised toRandomised to

Stenting

Stenting

Surgical decompression +/-

Resection

Surgical decompression +/-

Resection

To Stent or Not to StentTo Stent or Not to StentThat Is the QuestionThat 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 recurrence.

Possible worsening of QoL Possible worsening of QoL even after a successful SEMS insertioneven after a successful SEMS insertion

… … An elderly woman who presented with an An elderly woman who presented with an obstructing metastatic rectal cancer underwent obstructing metastatic rectal cancer underwent ‘successful’ insertion of SEMS and was ‘successful’ insertion of SEMS and was subsequently managed by the palliative care team. subsequently managed by the palliative care team.

She died peacefully after 6 months … She died peacefully after 6 months …

The twist of the story was that she spent her The twist of the story was that she spent her remaining days mostly on the toilet as the stent remaining days mostly on the toilet as the stent made her incontinent…made her incontinent…

D. Debnath. Br J Surg 2004D. Debnath. Br J Surg 2004

Stent Palliation of Stent Palliation of Malignant Colonic ObstructionMalignant Colonic Obstruction

Colorectal Disease 2006, 7Colorectal Disease 2006, 7

Bowel function is often poor in patients Bowel function is often poor in patients treated with CR stentstreated with CR stents

Functional outcome should be discussed Functional outcome should be discussed fully during the consenting process for the fully during the consenting process for the procedure.procedure.

Contraindications Contraindications to Colorectal Stentsto Colorectal Stents

Long Life ExpectancyLong Life Expectancy

Right sided occlusionsRight sided occlusions

Incomplete occlusionIncomplete occlusion

Cancers ≤ 5 cm from the anal vergeCancers ≤ 5 cm from the anal verge

Severe anemia by bleeding cancersSevere anemia by bleeding cancers

(Extracolonic Malignancies)(Extracolonic Malignancies)

• The decision to insert a SEMS or to perform a The decision to insert a SEMS or to perform a colostomy involves multiple areas of uncertainty… colostomy involves multiple areas of uncertainty…

• The longer a SEMS remains in place, the The longer a SEMS remains in place, the greater the amount of uncertainty surrounding its greater the amount of uncertainty surrounding its effectiveness and the higher the probability that effectiveness and the higher the probability that surgery is the preferred alternative surgery is the preferred alternative

da Silveira E, Barkun AN.Gastrointest Endosc. 2008.

• Utilization of SEMS for conditions that have not Utilization of SEMS for conditions that have not been thoroughly investigated (ie, long-term been thoroughly investigated (ie, long-term palliation of CRC) cannot be recommended yet ...palliation of CRC) cannot be recommended yet ...

• … … but short ‘‘bridges’’ from acute obstruction to but short ‘‘bridges’’ from acute obstruction to surgery can be safely ‘‘crossed’’ with the surgery can be safely ‘‘crossed’’ with the endoscopic insertion of a colonic SEMSendoscopic insertion of a colonic SEMS

da Silveira E, Barkun AN.Gastrointest Endosc. 2008.

Acute Occlusion = Bridge to SurgeryAcute Occlusion = Bridge to Surgery

Palliation: Stent only if occlusionPalliation: Stent only if occlusion

If CT planned, consider resectionIf CT planned, consider resection

Discuss with the patient Discuss with the patient ((InformedInformed Consent) Consent)

Stent Palliation of Stent Palliation of Malignant Colonic ObstructionMalignant Colonic Obstruction

Take Home MessagesTake Home Messages

!!