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Clinical Practice Guidelines for the Treatment of Chronic Radiation Proctitis Ian M

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Clinical Practice Guidelines for the Treatment of Chronic Radiation Proctitis Ian M CLINICAL PRACTICE GUIDELINES The American Society of Colon and Rectal Surgeons Clinical Practice Guidelines for the Treatment of Chronic Radiation Proctitis Ian M. Paquette, M.D.1 • Jon D. Vogel, M.D.2 • Maher A. Abbas, M.D.3 Daniel L. Feingold, M.D.4 • Scott R. Steele, M.D., M.B.A.5 On behalf of the Clinical Practice Guidelines Committee of The American Society of Colon and Rectal Surgeons 1 University of Cincinnati Medical Center, Cincinnati, Ohio 2 Anschutz Medical Campus, University of Colorado Denver, Denver, Colorado 3 Al Zahra Hospital, Dubai, United Arab Emirates 4 Columbia University Medical Center, New York, New York 5 Cleveland Clinic, Cleveland, Ohio The American Society of Colon and Rectal Surgeons opment of a chronic hemorrhagic radiation proctitis. (ASCRS) is dedicated to ensuring high-quality patient care Chronic hemorrhagic radiation proctitis is a syndrome by advancing the science, prevention, and management marked by hematochezia, mucus discharge, tenesmus, of disorders and diseases of the colon, rectum, and anus. and, often, fecal incontinence.1 The incidence of this The Clinical Practice Guidelines Committee is charged condition was previously reported to be as high as 30%2; with leading international efforts in defining quality care however, with recent advances in radiation techniques, for conditions related to the colon, rectum, and anus by the delivery of a more targeted external beam radiation to developing clinical practice guidelines based on the best tumors will hopefully minimize collateral toxicity. Cur- available evidence. These guidelines are inclusive, not pre- rent estimates are that ~1% to 5% of patients treated with scriptive, and are intended for the use of all practitioners, radiation for pelvic malignancy will experience chronic healthcare workers, and patients who desire information radiation proctitis.1 Because of the nature of the symp- about the management of the conditions addressed by the toms associated with this condition, colorectal surgeons topics covered in these guidelines. Their purpose is to pro- are frequently called on for management and should be vide information on which decisions can be made rather well versed in the various treatment options. This param- than to dictate a specific form of treatment. eter will grade the evidence of the common interventions, which have been described for chronic hemorrhagic ra- diation proctitis. STATEMENT OF THE PROBLEM Radiation therapy is frequently used in many types of METHODOLOGY cancer, including anal, cervical, prostate, and rectal. Al- though radiation has beneficial effects in treating tumors, PubMed was used to search MEDLINE for all entries from collateral damage to the GI tract can occur, and although January 1990 to October 26, 2017, with the results limited acute toxicity in the form of either proctitis or enteritis to human studies. Search terms included radiation proctitis may occur, the more concerning symptom is the devel- (n = 757 titles), radiation enteritis (n = 492), radiation proctitis AND each of the following terms: antibiotics (n = 10), argon Funding/Support: None reported. beam (n = 16), aminosalicylate enema (n = 5), Carafate enema (n = 16), endoscopy (n = 130), formalin (n = 90), hyperbaric Financial Disclosure: None reported. oxygen (n = 56), short chain fatty acid (n = 15), and steroid en- ema (n = 13). The Cochrane Database of Systematic Reviews Correspondence: Scott R. Steele, M.D., M.B.A., Cleveland Clinic Foun- was searched with the term radiation proctitis. These searches dation, Cleveland, OH 44915. E-mail: [email protected] yielded 1278 unique titles (PubMed = 1275, Cochrane = 3) Dis Colon Rectum 2018; 61: 1135–1140 that were screened, and 365 references were directly reviewed, DOI: 10.1097/DCR.0000000000001209 ultimately yielding 56 references for inclusion. Prospective, © The ASCRS 2018 randomized controlled trials and meta-analyses were given DISEASES OF THE COLON & RECTUM VOLUME 61: 10 (2018) 1135 Copyright © The American Society of Colon & Rectal Surgeons, Inc. Unauthorized reproduction of this article is prohibited. 1136 PAQUETTE ET AL: TREATMENT OF CHRONIC RADIATION PROCTITIS TABLE 1. The Grade of Recommendation, Assessment, Development, and Evaluation system: grading recommendations Methodologic quality of supporting Description Benefit vs risk and burdens evidence Implications 1A Strong recommendation, Benefits clearly outweigh risk RCTs without important limitations Strong recommendation, can apply to high-quality evidence and burdens or vice versa or overwhelming evidence from most patients in most circumstances observational studies without reservation 1B Strong recommendation, Benefits clearly outweigh risk RCTs with important limitations Strong recommendation, can apply to moderate-quality evidence and burdens or vice versa (inconsistent results, most patients in most circumstances methodologic flaws, indirect, without reservation or imprecise) or exceptionally strong evidence from observational studies 1C Strong recommendation, Benefits clearly outweigh risk Observational studies or case Strong recommendation but may low- or very low–quality and burdens or vice versa series change when higher quality evidence evidence becomes available 2A Weak recommendation, Benefits closely balanced RCTs without important limitations Weak recommendation, best high-quality evidence with risks and burdens or overwhelming evidence from action may differ depending on observational studies circumstances or patient or societal values 2B Weak recommendations, Benefits closely balanced RCTs with important limitations Weak recommendation, best moderate-quality evidence with risks and burdens (inconsistent results, action may differ depending on methodologic flaws, indirect, circumstances or patient or societal or imprecise) or exceptionally values strong evidence from observational studies 2C Weak recommendation, Uncertainty in the estimates Observational studies or case Very weak recommendations, other low- or very low–quality of benefits, risks, and series alternatives may be equally evidence burden; benefits, risk, reasonable and burden may be closely balanced Adapted and reprinted with permission from Chest. 2006;129:174–181. RCT = randomized controlled trial. preference in developing these guidelines. Directed searches The typical patient with chronic radiation proctitis (CRP) of the embedded references from the primary articles were will present with hematochezia. Other common symptoms also performed in certain circumstances. The final source are fecal urgency, tenesmus, or drainage of mucus from the material used was evaluated for the methodologic quality, rectum.1,2 It is important to review the history of the prima- the evidence base was examined, and a treatment guideline ry disease process and the radiation dose received. Because was formulated by the subcommittee for this guideline. The the most common indications for pelvic radiation therapy final grade of recommendation was performed using the are malignancies (anal cancer, uterine cancer, cervical can- Grade of Recommendation, Assessment, Development, and cer, prostate cancer, and rectal cancer), it is important to as- Evaluation system3 (Table 1). Members of the ASCRS Clinical sess the patient for recurrence of his or her primary cancer Practice Guidelines Committee worked in joint production with physical examination or imaging where appropriate. of these guidelines from inception to final publication. Rec- At a minimum, a digital rectal examination should be per- formed to evaluate sphincter tone, as well as a proctoscopic ommendations formulated by the subcommittee were then examination to evaluate the quality of the mucosa, distribu- reviewed by the entire Clinical Practice Guidelines Commit- tion of disease, and to rule out malignancy.4 Colonoscopy is tee for edits and recommendations. Final recommendations indicated if proctoscopy cannot delineate the full extent of were approved by the ASCRS Clinical Guidelines Committee disease, if it is impossible to rule out another form of colitis, and ASCRS Executive Committee. In general, each ASCRS or if the patient meets criteria for colonoscopy, as described Clinical Practice Guideline is updated every 3 to 5 years. by the US Multi-Society Task Force on Colorectal Cancers.5 Evaluation of Chronic Radiation Proctitis Prophylactic measures, such as pedicled omental flap and tissue expander implant, have been described to de- A disease-specific history and physical examination crease the incidence of radiation proctitis. These tech- should be performed, emphasizing the degree and du- niques are insufficiently evaluated and are not routinely ration of bleeding. Grade of Recommendation: Strong recommended. Grade of Recommendation: Strong rec- recommendation based on low-quality evidence, 1C. ommendation based on low-quality evidence, 1C. Copyright © The American Society of Colon & Rectal Surgeons, Inc. Unauthorized reproduction of this article is prohibited. DISEASES OF THE COLON & RECTUM VOLUME 61: 10 (2018) 1137 In the early 1990s, studies emerged describing methods to of patients after 1 treatment.17 An additional study from Po- exclude the small bowel from the pelvis and to decrease land reported the outcome of 4% formalin application in 20 the incidence of radiation enteritis. The first such study patients with radiation proctitis.18 Most patients required was a multicenter trial from Europe describing a mesh an average of 2 treatments (range, 1–5). After the first ap- sling to exclude
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