Colorectal stenting. Alessandro Repici, MD Digestive Endoscopy Unit IRCCS Istituto Clinico Humanitas Milano, Italy

Transcription

1 Colorectal stenting Alessandro Repici, MD Digestive Endoscopy Unit IRCCS Istituto Clinico Humanitas Milano, Italy

2 Metal Stents for Obstructing Colorectal Cancer Dohomoto was credited as the first to report on metallic stenting in the rectum. Dig End 1991 Spinelli P et al. Self-expanding mesh stents for endoscopic palliation of rectal obstructing tumors. Surgical Endoscopy 1992; 6:72-76 Spinelli P et al. Rectal metal stents for palliation of colorectal malignant stenosis. Bildgebung 1993

3 2007 Br J Surgery 2007

4 Endoscopic Stent Placement as a Bridge to Surgery in Malignant Colorectal Obstruction: A Balance between Study Validity and Real-World Applicability Barham K. Abu Dayyeh, MD, MPH 1 and Todd H. Baron, MD,Am J Gastroenterology Dec 2011 The premise of self-expandable metal stent placement to restore luminal continuity in patients with acute left-sided malignant colonic obstruction is intuitively logical. However, the available body of literature addressing their benefit in this setting is contradictory More than two decades later and after multiple retrospective studies and four randomized, prospective, non-blinded trials, the jury is still out about their real-world effectiveness in this setting The reasons for this are multi-factorial and include shortcomings of the published literature, variability in case-mix and potential for selection bias, vast heterogeneity in the technical success rates and risk profiles of colonic stent placement

5

6 Implications for practice: Authors Conslusions 1. Colorectal stenting has no advantages to Emergency surgery in malignant colorectal obstructions. Emergency surgery appears to have high clinical success rate compared to colorectal stenting. The stent related complications are acceptable. Colorectal stenting has the advantage of shorter hospital stay and procedure time and less blood loss with comparable mortality and morbidity to emergency surgery. 2. Malignant colonic obstruction is a critical condition and relief by colorectal stents requires dedicated specialised units with endoscopic/radiological facilities 3. Colorectal stent insertion should only be performed by experienced endoscopists or radiologists with adequate interventional experience

7 Surgical management of malignant LBO Patients with malignant LBO are older with more comorbities and have more advanced diseases Mortality rate 5-14% Morbidity rate 15-55% One-stage surgery in less than 25% of cases Temporary ileostomies will be not closed in ¼ of the patients Permanent stoma do report a significant lower health-related quality of life S. Breitenstein, et al; Systematic evaluation of surgical strategies for acute malignant left-sided colonic obstruction; British Journal of Surgery 2007; 94:

8 Large Bowel Obstruction (LBO) Stage IV Stage IV

9

10

11 452 patients of mean age 67.5 years were included, of whom 78.8% had an emergency operation. The most common diagnosis was cancer (58.6%) After 44 months, only 159 (35.2%) patients had undergone reversal The most frequent reason why reversal was not done was death (74 [25%] patients). The mortality was 3.5%. Complications occurred in 45.2%, with a 6.2% rate of anastomotic leakage. Roig JV, Colorectal Disease 2011

12 Hartmann s operation

13 Of all colon cancer, patients with emergency resection, 33% died in the first year

14 377 patients were included in the analysis of outcome: 173 (45.9%) had obstructing cancers at or proximal to the splenic flexure, and 204 (54.1%) had lesions distal to the splenic flexure. Overall morbidity rate was 54% in the distal and 55,5% in the proximal colon The prevalence of anastomotic leakage was significantly higher for rightsided tumours (16.5%) than for left-sided tumours (7.7%) (p = 0.014). The mean hospital stay was 20.4 days (range, days) in the proximal group and 19.3 days (range, 5 90 days) in the distal group (p = 0.538). The 30-day mortality rate was 14.5% in the proximal cancer group and 14.7% in the distal cancer group (p = 0.944). Colorectal Disease 2011

15

16 The issue of perforation became dramatic after 2008

17 Arch Surg 2009

18 Two more landmark studies van Hoof J, et al Lancet Oncology 2011 Prospective randomized study (25 centers in Netherland) 48 received stents and 51 underwent surgery Higher 30-day morbidity rate (0 19 (95% CI 0 06 to 0 41) in the stent group 6 patients (13%) reporting early or delayed perforation The study prematurely closed after interim analysis Pirlet I, et al Surg Endosc 2011 Prospective randomized study (9 centers in France) 60 patients, 30 randomized to stenting 56% of technical failure 10% perforation

19 Bevacizumab-based therapies and Colonic perforation after SEMS placement Is it time for a warning? Bevacizumab-based therapies Treated Untreated P 15.4% 6.8% 0.06 Small AJ et al. GIE 2010

20 PERFORATION IN COLORECTAL STENTING: A PRELIMINARY ANALYSIS OF LITERATURE DATA AND A SEARCH FOR RISK FACTORS E. van Halsema 1, J. van Hooft 1, P. Fockens 1, A. Repici 2 1 Department of Gastroenterology & Hepatology, Academic Medical Centre, Amsterdam, The Netherlands 2 Digestive Endoscopy, Istituto Clinico Humanitas, Rozzano (Milan), Italy UEGW, 2011 Methods This study was designed as a literature review with an additional request for data to authors of included articles when literature was insufficient. Database MEDLINE was searched from January 2005 to March 2011 for relevant English articles on colorectal stenting. Eighty-six studies met our inclusion criteria; 42 retrospective, 24 prospective, 7 case reports, 5 RCTs, 2 pro- and retrospective and 6 without describing study design. A pooled, univariate analysis was performed. Conclusions Baseline Characteristics Patients 4090 (100.0) Receiving stent 3865 (94.5) inability to pass stricture 175 (4.3) stent uncertain 50 (1.2) perforations 207 (5.1) Stenosis 3865 (100.0) malignant 3753 (97.1) benign 98 (2.5) missing 14 (0.4) Concomitant treatments none 1437 (35.1) chemotherapy 637 (15.6) bevacizumab 86 (2.1) missing 1930 (47.2) Stricture dilation 332 (8.1) none 2515 (61.5) intraprocedural pre-stent 146 (3.6) intraprocedural post-stent 190 (4.6) reintervention dilation 22 (0.5) missing 1243 (30.4) Benign strictures, concomitant bevacizumab and reintervention dilation were associated with increased risk of perforation in colonic stenting. Perforation rates of eight different stent types varied from 1.6 to 8.1%, but heterogeneity makes it difficult to draw firm conclusions from this finding % Perforation rate per stent type Stent design Comvi Stent Dual Stent Enteral Wallstent Hanarostent Niti-S Covered Niti-S D-type Ultraflex Precision Wallflex Colonic BENIGN STRICTURES 10.2% p = 0.021; OR 2.17 (95% C.I ) BEVACIZUMAB 12.6% p =.020; OR 2.17 (95% C.I ) REINTERVENTION DILATION 18.2% p =.018; OR 3.48 (95% C.I ) Perforation rate 5,1%

21 Self-expandable metal stents for malignant colorectal obstruction: short-term safety and efficacy 447 patients (Wallflex Registry) Two global registries with 39 academic and community centers This study involved 447 patients with malignant colonic obstruction who received stents (255 PAL, 182 BTS) The procedural success rate was 94.8% (439/463), and the clinical success rates were 90.5% (313/346) 15 (3.9%) perforations, 3 resulting in death, 7 (1.8%) migrations, 7 (1.8%) cases of pain, and 2 (0.5%) cases of bleeding Mesiner S, et al GIE 2011

22 Hapani S, et al Lancet Oncology 2009

23 Tan CJ, et al Br J Surg, April 2012

24 Tan CJ, et al Br J Surg, April 2012

25 Endoscopic Stent Placement as a Bridge to Surgery in Malignant Colorectal Obstruction: A Balance between Study Validity and Real-World Applicability Barham K. Abu Dayyeh, MD, MPH 1 and Todd H. Baron, MD 1 Am J Gastroenterol Dec 2011 The individual clinician and the endoscopist should honestly assess whether the capabilities for high insertion and low complication rates are achievable for a particular patient, especially in those patients at highest risk not only of complications from emergency surgery but that of medical management with delayed surgery.

26 Are we ready to provide this service 24h/7day? An Italian survey Number of Units ERCP Enteral Stents 24H service for bowel obstruction 10,8% 0 Question 1 Question 2 Question 3 Repici A, et al, submitted to UEGW

27 Stent Colonic Manufacturer Expanded length (mm) Diameter (mm) TTS/ OTW Introduction System Fr size Working length (cm) Evolution Colonic Stent Cook Medical 60, 80, /25 TTS Ultraflex Precision Colonic Stent Boston Scientific/Microvasive, Natick, MA 57, 87, /25 OTW Wallstent Colonic & Duodenal Boston Scientific/Microvasive, Natick, MA 60, 90 18, 20,22 TTS WallFlex Enteral Colonic Stent Boston Scientific/Microvasive, Natick, MA 60,90,120 30/25 27/22 TTS Colonic Z-Stent Cook Medical Winston-Salem, NC 40, 60, 80, 100, /25 OTW Silky Colo-Rectal Stent Stentech Seoul Korea Covered / Uncovered 50,60,70;80,90,100,120,140, TTS Niti-S Colorectal Stent Taewoong-Medical Co., Ltd, Seoul, South Korea Uncovered 60, 80, /20 30/22 30/24 28/20 OTW Niti-S Colorectal Stent Taewoong-Medical Co., Ltd, Seoul, South Korea Covered 60,80, /22 30/24 OTW BONA Stent Colo-rectal Standard Sci.Tech Inc Uncovered 60, 80, /24/26 TTS / OTW BONA Stent Colo-rectal Standard Sci.Tech Inc Covered 60,80,100 30/50/80 22/24/26 TTS / OTW Hanaro Colorectal Stent M.I TECH Co ltd 40,70; TTS ECO stent Leufen Medizintechnik OHG Uncovered 80,100 30/36 OTW 24 SX-ELLA Stent colorectal ELLA-CS, Prague, Czech Republic 82,90,113,135 75,88,112,123, ,25,30 OTW Micro-Tech colon and rectum stent Micro-tech Europe Dusseldorf Germany Uncovered 80/100/120 Covered 80/100/120 50/70/90 30/36 25/30 TTS 10 / /230 Adapted from Repici A, GIE Clin N Am 2011