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Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial

Phase 4
Not Enrolling
Chronic Radiation Proctitis

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Trial Information

Argon Plasma Coagulation Plus Placebo or Oral Sucralfate for Chronic Radiation Proctopathy: a Randomized Placebo Controlled Trial

Chronic radiation proctopathy (CRP) or proctosigmoiditis is a late complication of pelvic
radiotherapy. Symptoms, including diarrhea, rectal bleeding, urgency, and tenesmus, are
difficult to treat and adversely impact patient quality of life. Various treatments directed
at the reduction of blood loss and improvement of other symptoms have been evaluated, with
the most encouraging results reported for two methods: endoscopic argon plasma coagulation
(APC) of radiation-induced abnormal vessels in the rectal mucosa, and administration of
sucralfate, a drug believed to enhance the mucosal defense and healing when administered
orally or rectally. Adequately powered randomized trials comparing various treatments are
lacking, and an optimal management strategy has yet to be determined. To address this issue,
we conducted a single-center, randomized, placebo-controlled, double-blind study comparing
the efficacy and safety of APC alone and APC in combination with sucralfate administered

Inclusion Criteria:

- radiotherapy due to pelvic tumors completed at least three months prior to enrollment

- presence of rectal bleeding

- radiation-induced telangiectasia in the rectum and/or sigmoid colon on endoscopy

- informed written consent to participate in the study

Exclusion Criteria:

- history of clinically significant rectal bleeding prior to radiotherapy

- conditions predisposing the patient to rectal bleeding including inflammatory bowel
disease, tumors of the large bowel, intestinal vascular lesions (other than
radiation-induced telangiectasia), and diversion of the fecal stream

- sucralfate treatment during the two weeks prior to enrollment

- renal insufficiency (creatinine level ≥2 mg/dl)

- concurrent chemotherapy

- concurrent therapy with tetracycline, fluoroquinolones, or antimycotic drugs (because
of drug interaction)

- concurrent therapy with oral anticoagulants

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

change in disease severity scores, as assessed using our three-item symptom scale

Outcome Description:

Three-item symptom scale Diarrhea - score 1: 1-3 stools/24 h; 2: 4-6 stools/24 h; 3 >6 stools/24 h Bleeding - score 0: No blood; 1: Blood on toilet paper or stool; 2: Blood in toilet bowl; 3: Heavy bleeding with clots; 4: Bleeding requiring transfusions Tenesmus/rectal pain - score 0: Absent; 1: Mild tenesmus not requiring any drug; 2: Tenesmus requiring analgesics/antispasmodics; 3: Severe tenesmus requiring everyday use of analgetics/antispasmodics.

Outcome Time Frame:

baseline vs. 16 week

Safety Issue:


Principal Investigator

Magdalena R Chruscielewska-Kiliszek, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Medical Centre for Postgraduate Education


Poland: Ministry of Science and Higher Education

Study ID:




Start Date:

June 2003

Completion Date:

June 2007

Related Keywords:

  • Chronic Radiation Proctitis
  • chronic radiation proctopathy
  • argon plasma coagulation
  • sucralfate
  • Proctitis