Safe Treatment of Intestinal Strictures in Crohn's Disease
Safe Treatment of Intestinal Strictures in Crohn's Disease
The study comprised 178 patients, including both patients from the primary catchment area of the hospital (n = 125) and referred patients (n = 53). Patients were retrospectively identified by running the register of surgical procedures against the diagnosis register at the Departments of Medicine and Surgery at Örebro University Hospital during the period 1987, when the first dilation was performed, to 2009. Search items were 'endoscopic balloon dilation' (4488 and 4886 according to the Classification of Surgical Procedures version 6 and JDA 55, JDH 32, JFA 38, JFA 58 and JGA 58 according to Classification of Surgical Procedures version 7) and 'Crohn's disease' (555A, 555B, 555C and 555X according to International Classification of Diseases version 9 and K.50.0, K.50.1, K.50.8 and K.50.9 according to International Classification of Diseases version 10). Demographic data, clinical characteristics and endoscopic and surgical procedures were searched for in the medical records at the Departments of Medicine and Surgery.
Diagnosis of CD was based on Lennard-Jones criteria. Disease location and behaviour were classified according to Montreal classification.
All patients were included in the calculations on technical success and complications. To reduce the risk of referral bias, analyses of clinical efficacy were restricted to patients from our primary catchment area. These patients had a regular follow-up at our outpatient colitis clinic.
Patients from the primary catchment area were separated into two groups. One group consisted of patients who, after the index dilation, underwent further endoscopic dilations due to recurrent symptomatic bowel strictures only (n = 83). The other group consisted of patients who anytime had further stricture dilations performed without associated clinical symptoms of bowel obstruction (n = 42).
A bowel stricture was considered to exist when passage of a standard colonoscope was not possible. A symptomatic stricture refers to a stricture associated with clinical symptoms of bowel obstruction such as postprandial abdominal pain, vomiting and nausea. Anastomotic strictures have been considered most appropriate for endoscopic dilation, and the authors have generally been restrictive in treating de novo strictures, especially colonic strictures. Concomitant fistula or abscesses have been exclusion criteria. In most cases, the stricture was documented by a small bowel follow-through or enteroclysis, or in recent years a magnetic resonance tomography of the small bowel. In patients with symptoms of bowel obstruction and a previous history of stricturing CD, colonoscopy was performed without prior radiological investigation. In the early study period, repeated dilations 1–4 times/year were performed in some patients without any clinical symptoms of bowel obstruction, as this practice might reduce the risk of surgery. During the latter study period, dilation was performed principally only in patients with strictures causing recurrent clinical symptoms of bowel obstruction. Analyses of long-term outcome will be restricted to the latter group of patients.
Endoscopic dilation was generally done as an outpatient procedure using conscious sedation with midazolam and/or alfentanil or diazepam and/or pethidine. A few procedures were done under general anaesthesia. Several different physicians with variable endoscopic skill performed the dilation procedure. Standard colonoscope (Olympus, Hamburg, Germany; Pentax Europe GmbH, Hamburg, Germany) and through-the-scope dilation balloons with a maximal diameter of 12 to 25 mm (Boston Scientific, Cork, Ireland; Cook Medical Europe Ltd, Limerick, Ireland) were used. The balloon was positioned under visual control in the stricture and inflated with water stepwise with a gradually increasing diameter. Inflation time varied between 1 and 3 min. The procedure was repeated until the colonoscope could pass through the stricture. Fluoroscopy was not used. After the procedure, patients were observed for at least 2 h in a recovery room.
Outcome measures were technical and clinical efficacy and complication rates. Technical success was defined as being able to pass the endoscope through the stricture after the procedure. Short-term clinical success was defined as relief of clinical symptoms of bowel obstruction during the following month after the endoscopic procedure. Long-term efficacy was assessed on proportion of patients undergoing no further procedure, one dilation, two dilations, three dilations, >3 dilations or surgery for each year during the first 5 years after index dilation. Evaluation of clinical efficacy was made in patients from the primary catchment area only, whereas technical success was assessed in all patients, including referred patients. Surgery refers to any operation leading to intestinal resection or strictureplasty.
Complications such as bowel perforation, bleeding, abdominal pain, fever or death following the procedure and requiring hospital stay or prolonged hospital stay were assessed in all patients. Major bleeding was defined as any bleeding requiring blood transfusion.
Data are presented as median and interquartile range (IQR). Differences between groups were tested with Chi-squared test, or when appropriate Fisher's exact test and a P-value <0.05 was statistically significant. Time to first surgical procedure after index dilation was illustrated with Kaplan–Meier plot and differences between groups were tested with log-rank test.
This study was approved by the Regional Ethics Review Board in Uppsala.
Material and Methods
Patients
The study comprised 178 patients, including both patients from the primary catchment area of the hospital (n = 125) and referred patients (n = 53). Patients were retrospectively identified by running the register of surgical procedures against the diagnosis register at the Departments of Medicine and Surgery at Örebro University Hospital during the period 1987, when the first dilation was performed, to 2009. Search items were 'endoscopic balloon dilation' (4488 and 4886 according to the Classification of Surgical Procedures version 6 and JDA 55, JDH 32, JFA 38, JFA 58 and JGA 58 according to Classification of Surgical Procedures version 7) and 'Crohn's disease' (555A, 555B, 555C and 555X according to International Classification of Diseases version 9 and K.50.0, K.50.1, K.50.8 and K.50.9 according to International Classification of Diseases version 10). Demographic data, clinical characteristics and endoscopic and surgical procedures were searched for in the medical records at the Departments of Medicine and Surgery.
Diagnosis of CD was based on Lennard-Jones criteria. Disease location and behaviour were classified according to Montreal classification.
All patients were included in the calculations on technical success and complications. To reduce the risk of referral bias, analyses of clinical efficacy were restricted to patients from our primary catchment area. These patients had a regular follow-up at our outpatient colitis clinic.
Patients from the primary catchment area were separated into two groups. One group consisted of patients who, after the index dilation, underwent further endoscopic dilations due to recurrent symptomatic bowel strictures only (n = 83). The other group consisted of patients who anytime had further stricture dilations performed without associated clinical symptoms of bowel obstruction (n = 42).
Stricture and Endoscopic Dilation
A bowel stricture was considered to exist when passage of a standard colonoscope was not possible. A symptomatic stricture refers to a stricture associated with clinical symptoms of bowel obstruction such as postprandial abdominal pain, vomiting and nausea. Anastomotic strictures have been considered most appropriate for endoscopic dilation, and the authors have generally been restrictive in treating de novo strictures, especially colonic strictures. Concomitant fistula or abscesses have been exclusion criteria. In most cases, the stricture was documented by a small bowel follow-through or enteroclysis, or in recent years a magnetic resonance tomography of the small bowel. In patients with symptoms of bowel obstruction and a previous history of stricturing CD, colonoscopy was performed without prior radiological investigation. In the early study period, repeated dilations 1–4 times/year were performed in some patients without any clinical symptoms of bowel obstruction, as this practice might reduce the risk of surgery. During the latter study period, dilation was performed principally only in patients with strictures causing recurrent clinical symptoms of bowel obstruction. Analyses of long-term outcome will be restricted to the latter group of patients.
Endoscopic dilation was generally done as an outpatient procedure using conscious sedation with midazolam and/or alfentanil or diazepam and/or pethidine. A few procedures were done under general anaesthesia. Several different physicians with variable endoscopic skill performed the dilation procedure. Standard colonoscope (Olympus, Hamburg, Germany; Pentax Europe GmbH, Hamburg, Germany) and through-the-scope dilation balloons with a maximal diameter of 12 to 25 mm (Boston Scientific, Cork, Ireland; Cook Medical Europe Ltd, Limerick, Ireland) were used. The balloon was positioned under visual control in the stricture and inflated with water stepwise with a gradually increasing diameter. Inflation time varied between 1 and 3 min. The procedure was repeated until the colonoscope could pass through the stricture. Fluoroscopy was not used. After the procedure, patients were observed for at least 2 h in a recovery room.
Outcome
Outcome measures were technical and clinical efficacy and complication rates. Technical success was defined as being able to pass the endoscope through the stricture after the procedure. Short-term clinical success was defined as relief of clinical symptoms of bowel obstruction during the following month after the endoscopic procedure. Long-term efficacy was assessed on proportion of patients undergoing no further procedure, one dilation, two dilations, three dilations, >3 dilations or surgery for each year during the first 5 years after index dilation. Evaluation of clinical efficacy was made in patients from the primary catchment area only, whereas technical success was assessed in all patients, including referred patients. Surgery refers to any operation leading to intestinal resection or strictureplasty.
Complications such as bowel perforation, bleeding, abdominal pain, fever or death following the procedure and requiring hospital stay or prolonged hospital stay were assessed in all patients. Major bleeding was defined as any bleeding requiring blood transfusion.
Statistics
Data are presented as median and interquartile range (IQR). Differences between groups were tested with Chi-squared test, or when appropriate Fisher's exact test and a P-value <0.05 was statistically significant. Time to first surgical procedure after index dilation was illustrated with Kaplan–Meier plot and differences between groups were tested with log-rank test.
Ethics
This study was approved by the Regional Ethics Review Board in Uppsala.
Source...