DOI QR코드

DOI QR Code

Novel and Effective Almagate Enema for Hemorrhagic Chronic Radiation Proctitis and Risk Factors for Fistula Development

  • Yuan, Zi-Xu (Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-sen University) ;
  • Ma, Teng-Hui (Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-sen University) ;
  • Zhong, Qing-Hua (Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-sen University) ;
  • Wang, Huai-Ming (Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-sen University) ;
  • Yu, Xi-Hu (Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-sen University) ;
  • Qin, Qi-Yuan (Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-sen University) ;
  • Chu, Li-Li (Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-sen University) ;
  • Wang, Lei (Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-sen University) ;
  • Wang, Jian-Ping (Department of Colorectal Surgery, the Sixth Affiliated Hospital, Sun Yat-sen University)
  • Published : 2016.03.07

Abstract

Radiation proctitis is a common complication after radiotherapy for pelvic malignant tumors. This study was conducted to assess the efficacy of novel almagate enemas in hemorrhagic chronic radiation proctitis (CRP) and evaluate risk factors related to rectal deep ulcer or fistula secondary to CRP. All patients underwent a colonoscopy to confirm the diagnosis of CRP and symptoms were graded. Typical endoscopic and pathological images, risk factors, and quality of life were also recorded. A total of 59 patients were enrolled. Gynecological cancers composed 93.1% of the primary malignancies. Complete or obvious reduction of bleeding was observed in 90% (53/59) patients after almagate enema. The mean score of bleeding improved from 2.17 to 0.83 (P<0.001) after the enemas. The mean response time was 12 days. No adverse effects were found. Moreover, long-term successful rate in controlling bleeding was 69% and the quality of life was dramatically improved (P=0.001). The efficacy was equivalent to rectal sucralfate, but the almagate with its antacid properties acted more rapidly than sucralfate. Furthermore, we firstly found that moderate to severe anemia was the risk factor of CRP patients who developed rectal deep ulcer or fistulas (P= 0.015). We also found abnormal hyaline-like thick wall vessels, which revealed endarteritis obliterans and the fibrosis underlying this disease. These findings indicate that almagate enema is a novel effective, rapid and well-tolerated method for hemorrhagic CRP. Moderate to severe anemia is a risk factor for deep ulceration or fistula.

Keywords

Chronic radiation proctitis;hemorrhage;almagate;risk factor;rectal fistula;enema

Acknowledgement

Supported by : National Natural Science Foundation of China (NSFC)

References

  1. Aaronson NK, Ahmedzai S, Bergman B, et al (1993). The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst, 85, 365-76. https://doi.org/10.1093/jnci/85.5.365
  2. Anseline PF, Lavery IC, Fazio VW, et al (1981). Radiation injury of the rectum: evaluation of surgical treatment. ann surg.
  3. Beckett PR, Llupia J, Lumachi B, et al (1984). Pharmacological studies with almagate, a potent new antacid compound. Arzneimittelforschung, 34, 1367-70.
  4. Beneyto JE, Fabregas JL (1984). Effect of proteolytic enzymes and polypeptides on the antacid activity of almagate and other antacids. Arzneimittelforschung, 34, 1357-60.
  5. Charneau J, Bouachour G, Person B, et al (1991). Severe hemorrhagic radiation proctitis advancing to gradual cessation with hyperbaric oxygen. Dig Dis Sci, 36, 373-5. https://doi.org/10.1007/BF01318212
  6. Cho KH, Lee CK, Levitt SH (1995). Proctitis after conventional external radiation therapy for prostate cancer: importance of minimizing posterior rectal dose. Radiol, 195, 699-703. https://doi.org/10.1148/radiology.195.3.7753997
  7. Eaveiae J (2000). Metronidazole in the Treatment of Chronic Radiation Proctitis: Clinical Trial.
  8. Gul YA, Prasannan S, Jabar FM, et al (2002). Pharmacotherapy for chronic hemorrhagic radiation proctitis. World J Surg, 26, 1499-502. https://doi.org/10.1007/s00268-002-6529-8
  9. Haas EM, Bailey HR, Farragher I (2007). Application of 10 percent formalin for the treatment of radiation-induced hemorrhagic proctitis. Dis Colon Rectum, 50, 213-7. https://doi.org/10.1007/s10350-006-0707-y
  10. Hasleton PS, Carr N, Schofield PF (1985). Vascular changes in radiation bowel disease. Histopathol, 9, 517-34. https://doi.org/10.1111/j.1365-2559.1985.tb02833.x
  11. Hille A, Christiansen H, Pradier O, et al (2005). Effect of pentoxifylline and tocopherol on radiation proctitis/enteritis. Strahlenther Onkol, 181, 606-14. https://doi.org/10.1007/s00066-005-1390-y
  12. Khubchandani IT, Karamchandani MC, Sheets JA, et al (1987). The Bacon pull-through procedure. Dis Colon Rectum, 30, 540-4. https://doi.org/10.1007/BF02554786
  13. Kim TO, Song GA, Lee SM, et al (2008). Rebampide enema therapy as a treatment for patients with chronic radiation proctitis: initial treatment or when other methods of conservative management have failed. Int J Colorectal Dis, 23, 629-33. https://doi.org/10.1007/s00384-008-0453-9
  14. Kochhar R, Patel F, Dhar A, et al (1991). Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate. Dig Dis Sci, 36, 103-7. https://doi.org/10.1007/BF01300096
  15. Kochhar R, Sharma SC, Gupta BB, et al (1988). Rectal sucralfate in radiation proctitis. Lancet, 2, 400.
  16. Kochhar R, Sriram PV, Sharma SC, et al (1999). Natural history of late radiation proctosigmoiditis treated with topical sucralfate suspension. Dig Dis Sci, 44, 973-8. https://doi.org/10.1023/A:1026612731210
  17. Leiper K, Morris AI (2007). Treatment of radiation proctitis. Clin Oncol, 19, 724-9. https://doi.org/10.1016/j.clon.2007.07.008
  18. Li N, Zhu W, Gong J, et al (2013). Ileal or ileocecal resection for chronic radiation enteritis with small bowel obstruction:outcome and risk factors. Am J Surg, 206, 739-47. https://doi.org/10.1016/j.amjsurg.2013.01.045
  19. Lopez-Herce J, Dorao P, Elola P, et al (1992). Frequency and prophylaxis of upper gastrointestinal hemorrhage in critically ill children: a prospective study comparing the efficacy of almagate, ranitidine, and sucralfate. The Gastrointestinal Hemorrhage Study Group. Crit Care Med, 20, 1082-9. https://doi.org/10.1097/00003246-199208000-00003
  20. Lucarotti ME, Mountford RA, Bartolo DC (1991). Surgical management of intestinal radiation injury. Dis Colon Rectum, 34, 865-9. https://doi.org/10.1007/BF02049698
  21. Mallick S, Madan R, Julka PK, et al (2015). Radiation Induced Cystitis and Proctitis - Prediction, Assessment and Management. Asian Pac J Cancer Prev, 16, 5589-94. https://doi.org/10.7314/APJCP.2015.16.14.5589
  22. Nagy L, Mozsik G, Vincze A, et al (1990). Effects of a novel Hungarian antacid containing Al and Mg (Tisacid) on mucosal prostaglandin generation and oxygen free radicals in normal rats. Drugs Exp Clin Res, 16, 197-203.
  23. Nowacki MP (1991). Ten years of experience with Parks' coloanal sleeve anastomosis for the treatment of postirradiation rectovaginal fistula. Eur J Surg Oncol, 17, 563-6.
  24. Osoba D, Rodrigues G, Myles J, et al (1998). Interpreting the significance of changes in health-related quality-of-life scores. J Clin Oncol, 16, 139-44. https://doi.org/10.1200/JCO.1998.16.1.139
  25. Parks AG, Allen CL, Frank JD, et al (1978). A method of treating post-irradiation rectovaginal fistulas. Br J Surg, 65, 417-21. https://doi.org/10.1002/bjs.1800650615
  26. Patel P, Subhas G, Gupta A, et al (2009). Oral vitamin A enhances the effectiveness of formalin 8% in treating chronic hemorrhagic radiation proctopathy. Dis Colon Rectum, 52, 1605-9. https://doi.org/10.1007/DCR.0b013e3181afbe3a
  27. Pesee M, Krusun S, Padoongcharoen P (2010). High dose rate cobalt-60 afterloading intracavitary therapy of uterine cervical carcinomas in Srinagarind hospital - analysis of complications. Asian Pac J Cancer Prev, 11, 491-4.
  28. Postgate A, Saunders B, Tjandra J, et al (2007). Argon plasma coagulation in chronic radiation proctitis. Endoscopy, 39, 361-5. https://doi.org/10.1055/s-2007-966284
  29. R K, Patel F, Dhar A, et al (1991). Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate.
  30. Rey E, Poves-Frances C, Sanchez G, et al (2004). Effects of effervescent ranitidine on gastric pH: comparison with almagate and placebo in fasting and postprandial conditions. Aliment Pharmacol Ther, 20, 683-8. https://doi.org/10.1111/j.1365-2036.2004.02178.x
  31. Talley NA, Chen F, King D, et al (1997). Short-chain fatty acids in the treatment of radiation proctitis: a randomized, doubleblind, placebo-controlled, cross-over pilot trial. Dis Colon Rectum, 40, 1046-50. https://doi.org/10.1007/BF02050927
  32. Wachter S, Gerstner N, Goldner G, et al (2000). Endoscopic scoring of late rectal mucosal damage after conformal radiotherapy for prostatic carcinoma. Radiother Oncol, 54, 11-9. https://doi.org/10.1016/S0167-8140(99)00173-5
  33. Wang CJ, Leung SW, Chen HC, et al (1998). The correlation of acute toxicity and late rectal injury in radiotherapy for cervical carcinoma: evidence suggestive of consequential late effect (CQLE). Int J Radiat Oncol Biol Phys, 40, 85-91. https://doi.org/10.1016/S0360-3016(97)00560-9
  34. Yang L, Lv Y (2012). Possible risk factors associated with radiation proctitis or radiation cystitis in patients with cervical carcinoma after radiotherapy. Asian Pac J Cancer Prev, 13, 6251-5. https://doi.org/10.7314/APJCP.2012.13.12.6251

Cited by

  1. Colostomy is a simple and effective procedure for severe chronic radiation proctitis vol.22, pp.24, 2016, https://doi.org/10.3748/wjg.v22.i24.5598