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A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients

Abstract

Background

Endoscopic stenting with a self-expandable metallic stent (SEMS) is a widely accepted procedure for malignant colonic obstruction. The Colonic Stent Safe Procedure Research Group conducted the present prospective feasibility study.

Methods

Our objectives were to estimate the safety and feasibility of SEMS placement as a bridge to surgery (BTS) for malignant colorectal obstruction. We conducted a prospective, observational, single-arm, multicenter clinical trial from March 2012 to October 2013. Each patient was treated with an uncovered WallFlex enteral colonic stent. Patients were followed up until discharge after surgery.

Results

A total of 518 consecutive patients were enrolled in this study. The cohort intended for BTS consisted of 312 patients (61 %), and the stent could be released in 305 patients. Technical and clinical success rates were 98 and 92 %, respectively. Elective surgery was performed in 297 patients, and emergency surgery was performed in eight patients for the treatment of complications. The overall preoperative complication rate was 7.2 %. Major complications, including perforation, occurred in 1.6 %, persistent colonic obstruction occurred in 1.0 %, and stent migration occurred in 1.3 % patients. The median time from SEMS to surgery was 16 days. Silent perforations were observed in 1.3 %. Open and laparoscopic surgery was performed in 121 and 184 patients, respectively. The tumor could be resected in 297 patients. The primary anastomosis rate was 92 %. The rate of anastomotic leakage was 4 %, and the overall stoma creation rate was 10 %. The median duration of hospitalization following surgery was 12 days. Overall postoperative morbidity and mortality rates were 16 and 0.7 %, respectively.

Conclusions

This largest, multicenter, prospective study demonstrates the feasibility of SEMS placement as a BTS for malignant colorectal obstruction. SEMS serves as a safe and effective BTS with acceptable stoma creation and complication rates in patients with acute malignant colonic obstruction.

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References

  1. 1.

    Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D (2011) Global cancer statistics. CA Cancer J Clin 61:69–90

    Article  PubMed  Google Scholar 

  2. 2.

    Matsuda A, Matsuda T, Shibata A, Katanoda K, Sobue T, Nishimoto H, The Japan Cancer Surveillance Research Group (2013) Cancer incidence and incidence rates in Japan in 2008: a study of 25 population-based cancer registries for the monitoring of cancer incidence in Japan (MCIJ) Project. Jpn J Clin Oncol 44:388–396

    Article  Google Scholar 

  3. 3.

    Winner M, Mooney SJ, Hershman DL, Feingold DL, Allendorf JD, Wright JD, Neugut AI (2013) Incidence and predictors of bowel obstruction in elderly patients with stage IV colon cancer: a population-based cohort study. JAMA Surg 148:715–722

    Article  PubMed  PubMed Central  Google Scholar 

  4. 4.

    Jullumstro E, Wibe A, Lydersen S, Edna TH (2011) Colon cancer incidence, presentation, treatment and outcomes over 25 years. Colorectal Dis 13:512–518

    CAS  Article  PubMed  Google Scholar 

  5. 5.

    Cheynel N, Cortet M, Lepage C, Benoit L, Faivre J, Bouvier AM (2007) Trends in frequency and management of obstructing colorectal cancers in a well-defined population. Dis Colon Rectum 50:1568–1575

    Article  PubMed  Google Scholar 

  6. 6.

    Iversen LH, Bülow S, Christensen IJ, Laurberg S, Harling H (2008) Danish Colorectal Cancer Group. Postoperative medical complications are the main cause of early death after emergency surgery for colonic cancer. Br J Surg 95:1012–1019

    CAS  Article  PubMed  Google Scholar 

  7. 7.

    Cuffy M, Abir F, Audisio RA, Longo WE (2004) Colorectal cancer presenting as surgical emergencies. Surg Oncol 13:149–157

    Article  PubMed  Google Scholar 

  8. 8.

    McArdle CS, Hole DJ (2004) Emergency presentation of colorectal cancer is associated with poor 5-year survival. Br J Surg 91:605–609

    CAS  Article  PubMed  Google Scholar 

  9. 9.

    Tejero E, Mainar A, Fernández L, Tobío R, De Gregorio MA (1994) New procedure for the treatment of colorectal neoplastic obstructions. Dis Colon Rectum 37:1158–1159

    CAS  Article  PubMed  Google Scholar 

  10. 10.

    Saida Y, Sumiyama Y, Nagao J, Takase M (1996) Stent endoprosthesis for obstructing colorectal cancers. Dis Colon Rectum 39:552–555

    CAS  Article  PubMed  Google Scholar 

  11. 11.

    Martinez-Santos C, Lobato RF, Fradejas JM, Pinto I, Ortega-Deballon P, Moreno-Azcoita M (2002) Self-expandable stent before elective surgery vs. emergency surgery for the treatment of malignant colorectal obstructions: comparison of primary anastomosis and morbidity rates. Dis Colon Rectum 45:401–406

    Article  PubMed  Google Scholar 

  12. 12.

    ASGE Standards of Practice Committee, Harrison ME, Anderson MA, Appalaneni V, Banerjee S, Ben-Menachem T, Cash BD, Fanelli RD, Fisher L, Fukami N, Gan S, Ikenberry SO, Jain R, Khan K, Krinsky ML, Maple JT, Shen B, Guilder TV, Baron TH, Dominitz JA (2010) The role of endoscopy in the management of patients with known and suspected colonic obstruction and pseudo-obstruction. Gastrointest Endosc 71:669–679

    Article  Google Scholar 

  13. 13.

    Ansaloni L, Andersson RE, Bazzoli F, Catena F, Cennamo V, Di Saverio S, Fuccio L, Jeekel H, Leppäniemi A, Moore E, Pinna AD, Pisano M, Repici A, Sugarbaker PH, Tuech JJ (2010) Guidelines in the management of obstructing cancer of the left colon: consensus conference of the world society of emergency surgery (WSES) and peritoneum and surgery (PnS) society. World J Emerg Surg 5:29

    Article  PubMed  PubMed Central  Google Scholar 

  14. 14.

    Sebastian S, Johnston S, Geoghegan T, Torreggiani W, Buckley M (2004) Pooled analysis of the efficacy and safety of self-expanding metal stenting in malignant colorectal obstruction. Am J Gastroenterol 99:2051–2057

    Article  PubMed  Google Scholar 

  15. 15.

    Khot UP, Lang AW, Murali K, Parker MC (2002) Systematic review of the efficacy and safety of colorectal stents. Br J Surg 89:1096–1102

    CAS  Article  PubMed  Google Scholar 

  16. 16.

    Cirocchi R, Farinella E, Trastulli S, Desiderio J, Listorti C, Boselli C, Parisi A, Noya G, Sagar J (2013) Safety and efficacy of endoscopic colonic stenting as a BTS in the management of intestinal obstruction due to left colon and rectal cancer: a systematic review and meta-analysis. Surg Oncol 22:14–21

    Article  PubMed  Google Scholar 

  17. 17.

    Cennamo V, Luigiano C, Coccolini F, Fabbri C, Bassi M, De Caro G, Ceroni L, Maimone A, Ravelli P, Ansaloni L (2013) Meta-analysis of randomized trials comparing endoscopic stenting and surgical decompression for colorectal cancer obstruction. Int J Colorectal Dis 28:855–863

    Article  PubMed  Google Scholar 

  18. 18.

    Watt AM, Faragher IG, Griffin TT, Rieger NA, Maddern GJ (2007) Self-expanding metallic stents for relieving malignant colorectal obstruction: a systematic review. Ann Surg 246:24–30

    Article  PubMed  PubMed Central  Google Scholar 

  19. 19.

    van Hooft JE, Bemelman WA, Oldenburg B, Marinelli AW, Lutke Holzik MF, Grubben MJ, Sprangers MA, Dijkgraaf MG, Fockens P (2011) Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: a multicentre randomised trial. Lancet Oncol 12:344–352

    Article  PubMed  Google Scholar 

  20. 20.

    van Hooft JE, Fockens P, Marinelli AW, Bossuyt PM, Bemelman WA (2006) Dutch stent-in study group. Premature closure of the Dutch stent-in I study. Lancet 368:1573–1574

    Article  PubMed  Google Scholar 

  21. 21.

    Tan KK, Zhang J, Liu JZ, Shen SF, Earnest A, Sim R (2009) Right colonic perforation in an Asian population: predictors of morbidity and mortality. J Gastrointest Surg 13:2252–2259

    Article  PubMed  Google Scholar 

  22. 22.

    Anwar MA, D’Souza F, Coulter R, Memon B, Khan IM, Memon MA (2006) Outcome of acutely perforated colorectal cancers: experience of a single district general hospital. Surg Oncol 15:91–96

    Article  PubMed  Google Scholar 

  23. 23.

    Tan CJ, Dasari BV, Gardiner K (2012) Systematic review and meta-analysis of randomized clinical trials of self-expanding metallic stents as a bridge to surgery versus emergency surgery for malignant left-sided large bowel obstruction. Br J Surg 99:469–476

    CAS  Article  PubMed  Google Scholar 

  24. 24.

    Huang X, Lv B, Zhang S, Meng L (2014) Preoperative colonic stents versus emergency surgery for acute left-sided malignant colonic obstruction a meta-analysis. J Gastrointest Surg 18:584–591

    Article  PubMed  Google Scholar 

  25. 25.

    Saida Y, Sumiyama Y, Nagao J, Uramatsu M (2003) Long-term prognosis of preoperative ‘‘bridge to surgery’’ expandable metallic stent insertion for obstructive colorectal cancer: comparison with emergency operation. Dis Colon Rectum 46:S44–S49

    PubMed  Google Scholar 

  26. 26.

    Yoshida S, Watabe H, Isayama H, Kogure H, Nakai Y, Yamamoto N, Sasaki T, Kawakubo K, Hamada T, Ito Y, Yashima Y, Sasahira N, Hirano K, Yamaji Y, Tada M, Omata M, Koike K (2013) Feasibility of a new self-expandable metallic stent for patients with malignant colorectal obstruction. Dig Endosc 25:160–166

    Article  PubMed  Google Scholar 

  27. 27.

    Colonic Stent Safe Procedure Research Group. http://www.colon-stent.com/001_mainpage_en.html

  28. 28.

    Matsuzawa T, Ishida H, Yoshida S, Isayama H, Kuwai T, Maetani I, Shimada M, Yamada T, Saito S, Tomita M, Koizumi K, Hirata N, Sasaki T, Enomoto T, Saida Y (2015) A Japanese prospective multicenter study of self-expandable metallic stent placement for malignant colorectal obstruction: short-term safety and efficacy within 7 days of stent procedure in 513 cases. Gastrointest Endosc 82:697–707

    Article  PubMed  Google Scholar 

  29. 29.

    Adler DG, Baron TH (2002) Endoscopic palliation of malignant gastric outlet obstruction using self-expanding metal stents: experience in 36 patients. Am J Gastroenterol 97:72–78

    Article  PubMed  Google Scholar 

  30. 30.

    Tekkis PP, Kinsman R, Thompson MR, Stamatakis JD, Association of Coloproctology of Great Britain I (2004) The Association of Coloproctology of Great Britain and Ireland study of large bowel obstruction caused by colorectal cancer. Ann Surg 240:76–81

    Article  PubMed  PubMed Central  Google Scholar 

  31. 31.

    Jiménez-Pérez J, Casellas J, García-Cano J, Vandervoort J, García-Escribano OR, Barcenilla J, Delgado AA, Goldberg P, Gonzalez-Huix F, Vázquez-Astray E, Meisner S (2011) Colonic stenting as a bridge to surgery in malignant large-bowel obstruction: a report from two large multinational registries. Am J Gastroenterol 106:2174–2218

    Article  PubMed  Google Scholar 

  32. 32.

    Meisner S, González-Huix F, Vandervoort JG, Goldberg P, Casellas JA, Roncero O, Grund KE, Alvarez A, García-Cano J, Vázquez-Astray E, Jiménez-Pérez J (2011) Self-expandable metal stents for relieving malignant colorectal obstruction: short-term safety and efficacy within 30 days of stent procedure in 447 patients. Gastrointest Endosc 74:876–884

    Article  PubMed  Google Scholar 

  33. 33.

    Baron TH (2010) Colonic stenting: a palliative measure only or a bridge to surgery? Endoscopy 42:163–168

    CAS  Article  PubMed  Google Scholar 

  34. 34.

    Pirlet IA, Slim K, Kwiatkowski F, Michot F, Millat BL (2011) Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surg Endosc 25:1814–1821

    Article  PubMed  Google Scholar 

  35. 35.

    Sabbagh C, Browet F, Diouf M, Cosse C, Brehant O, Bartoli E, Mauvais F, Chauffert B, Dupas JL, Nguyen-Khac E, Regimbeau JM (2013) Is stenting as “a bridge to surgery” an oncologically safe strategy for the management of acute, left-sided, malignant, colonic obstruction? A comparative study with a propensity score analysis. Ann Surg 258:107–115

    Article  PubMed  Google Scholar 

  36. 36.

    van Hooft JE, van Halsema EE, Vanbiervliet G, Beets-Tan RG, DeWitt JM, Donnellan F, Dumonceau JM, Glynne-Jones RG, Hassan C, Jiménez-Perez J, Meisner S, Muthusamy VR, Parker MC, Regimbeau JM, Sabbagh C, Sagar J, Tanis PJ, Vandervoort J, Webster GJ, Manes G, Barthet MA, Repici A (2014) Self-expandable metal stents for obstructing colonic and extracolonic cancer: European Society of Gastrointestinal Endoscopy (ESGE) Clinical Guideline. Gastrointest Endosc 80:747–761

    Article  PubMed  Google Scholar 

  37. 37.

    Iversen LH, Kratmann M, Bøje M, Laurberg S (2011) Self-expanding metallic stents as bridge to surgery in obstructing colorectal cancer. Br J Surg 98:275–281

    CAS  Article  PubMed  Google Scholar 

  38. 38.

    Sloothaak DAM, van den Berg MW, Dijkgraaf MGW, Fockens P, Tanis PJ, van Hooft JE, Bemelman WA (2014) Oncological outcome of malignant colonic obstruction in Dutch Stent-In 2 trial. Br J Surg 101:1751–1757

    CAS  Article  PubMed  Google Scholar 

  39. 39.

    Tung KL, Cheung HY, Ng LW, Chung CC, Li MK (2013) Endo-laparoscopic approach versus conventional open surgery in the treatment of obstructing left-sided colon cancer: long-term follow-up of a randomized trial. Asian J Endosc Surg 6:78–81

    Article  PubMed  Google Scholar 

  40. 40.

    Alcantara M, Serra-Aracil X, Falco J, Mora L, Bombardo J, Navarro S (2011) Prospective, controlled, randomized study of intraoperative colonic lavage versus stent placement in obstructive left-sided colonic cancer. World J Surg 35:1904–1910

    CAS  Article  PubMed  Google Scholar 

  41. 41.

    Gorissen KJ, Tuynman JB, Fryer E, Wang L, Uberoi R, Jones OM, Cunningham C, Lindsey I (2013) Local recurrence after stenting for obstructing left-sided colonic cancer. Br J Surg 100:1805–1809

    CAS  Article  PubMed  Google Scholar 

  42. 42.

    Matsuda A, Miyashita M, Matsumoto S, Matsutani T, Sakurazawa N, Takahashi G, Kishi T, Uchida E (2014) Comparison of long-term outcomes of colonic stent as “bridge to surgery” and emergency surgery for malignant large-bowel obstruction: a meta-analysis. Ann Surg Oncol 22:497–504

    Article  PubMed  Google Scholar 

  43. 43.

    Koch M, Kienle P, Sauer P, Willeke F, Buhl K, Benner A, Lehnert T, Herfarth C, von Knebel Doeberitz M, Weitz J (2004) Hematogenous tumor cell dissemination during colonoscopy for colorectal cancer. Surg Endosc 18:587–591

    CAS  Article  PubMed  Google Scholar 

  44. 44.

    Maruthachalam K, Lash GE, Shenton BK, Horgan AF (2007) Tumour cell dissemination following endoscopic stent insertion. Br J Surg 94:1151–1154

    CAS  Article  PubMed  Google Scholar 

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Acknowledgments

This study was conducted with Japan Gastroenterological Endoscopy Society funding support and the Colonic Stent Safe Procedure Research Group membership dues.

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Corresponding author

Correspondence to Shuji Saito.

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Disclosures

Dr. Shuji Saito has received personal fees from Boston Scientific Japan, Century Medical Inc; Dr. Shuntaro Yoshida has received personal fees from Boston Scientific Japan, Century Medical Inc and ZEON Co, Dr. Hiroyuki Isayama has received donations and personal fees from Boston Scientific Japan, Century Medical Inc and Taewoong Medical Devices Inc. Drs. Takeaki Matsuzawa, Toshio Kuwai, and Mamoru Shimada have received personal fees from Boston Scientific Japan; Dr. Iruru Maetani has received personal fees from Boston Scientific Japan, Century Medical Inc, Piolax Medical Device Inc, and MC Medical Inc; Dr. Koichi Koizumi has received personal fees from Century Medical Inc and Olympus Medical Systems Corp; and Dr. Yoshihisa Saida has received grants and personal fees from Boston Scientific Japan, Century Medical Inc, and Olympus Medical Systems Corp. Drs. Tomonori Yamada, Masafumi Tomita, Nobuto Hirata, Hideki Kanazawa, Toshiyuki Enomoto, and Hitoshi Sekido have no conflicts of interest or financial ties to disclose.

Appendix

Appendix

The Colonic Stent Safe Procedure Research Group includes the following members in addition to the authors.

Tatsuya Osuga, Aijinkai Takatsuki General Hospital, Takatsuki, Japan; Masaki Kikkawa, Akita Red Cross Hospital, Akita, Japan; Mitsuru Goto, Asahikawa Kosei Hospital, Asahikawa, Japan; Shungo Endo, Fukushima Medical University Aizu Medical Center, Aizu-wakamatsu, Japan; Sayo Kobayashi, Fukuyama City Hospital, Fukuyama, Japan; Shigeru Yamagishi, Fujisawa City Hospital, Fujisawa, Japan; Ken Konishi, Higashiosaka City General Hospital, Higashiosaka, Japan; Masanori Yoshimitsu, Hiroshima City Asa Hospital, Hiroshima, Japan; Satoshi Ikeda, Hiroshima Prefectural Hospital, Hiroshima, Japan; Rintaro Moroi, Iwate Prefectural Isawa Hospital, Oshu, Japan; Michiaki Watanabe, Kawaguchi Municipal Medical Center, Kawaguchi, Japan; Hirofumi Kawamoto, Kawasaki Medical School, Okayama, Japan; Hirotoshi Hasegawa, Keio University School of Medicine, Tokyo, Japan; Atsushi Yamauchi, Kitano Hospital, Osaka, Japan; Fuminori Teraishi, Kochi Health Sciences Center, Kochi, Japan; Kohei Takayasu, Kyorin University Hospital, Mitaka, Japan; Takahiro Horimatsu, Kyoto University Hospital, Kyoto, Japan; Yoshinori Kushiyama, Matsue Red Cross Hospital, Matsue, Japan; Hiroaki Naota, Matsusaka Chuo General Hospital, Matsusaka, Japan; Takuya Yamaguchi, Mimihara General Hospital, Sakai, Japan; Shigenori Masaki, Miyanomori Memorial Hospital, Sapporo, Japan; Taku Sakamoto, National Cancer Center Hospital, Tokyo, Japan; Kazuhiro Watanabe, National Center for Global Health and Medicine, Tokyo, Japan; Masafumi Inomata, Oita University Faculty of Medicine, Oita, Japan; Nobuya Obana, Osaki Citizen Hospital, Osaki, Japan; Masayoshi Horimoto, Osaka Saiseikai Senri Hospital, Suita, Japan; Rika Kyo, Saiseikai Yokohamashi-Nanbu Hospital,Yokohama, Japan; Shinei Kudo, Showa University Northern Yokohama Hospital, Yokohama, Japan; Yasushi Nakamura, Takano Hospital, Kumamoto, Japan; Mitsunori Ushigome, Toho University Omori Medical Center, Tokyo, Japan; Takeshi Ohki, Tokyo Women’s Medical University, Tokyo, Japan; Hiroyuki Kato, Tokyo Women’s Medical University Medical Center East, Tokyo, Japan; Shiro Hayashi, Toyonaka Municipal Hospital, Toyonaka, Japan; Tomio Hirakawa, Yao Tokushukai General Hospital, Yao, Japan; and Kensuke Kubota, Yokohama City University Hospital, Yokohama, Japan.

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Saito, S., Yoshida, S., Isayama, H. et al. A prospective multicenter study on self-expandable metallic stents as a bridge to surgery for malignant colorectal obstruction in Japan: efficacy and safety in 312 patients. Surg Endosc 30, 3976–3986 (2016). https://doi.org/10.1007/s00464-015-4709-5

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Keywords

  • Colon and rectal cancer
  • Intestinal obstruction
  • Self-expandable metallic stent
  • Bridge to surgery
  • Multicenter study
  • Prospective cohort study