BACKGROUND: Benign gastroesophageal anastomotic strictures are common and often refractory to treatment. Various endoscopic dilation techniques have been reported, but none of these methods has been proven to be superior. OBJECTIVE: Comparison of the efficacy and safety of dilation of previously untreated anastomotic strictures by using electrocautery incision (EI) and Savary bougienage (SB). DESIGN: Randomized, prospective study. SETTING: Multicenter study. PATIENTS: Sixty-two patients with an anastomotic stricture after esophagogastrostomy and dysphagia Atkinson grades II to IV were included. INTERVENTIONS: Patients were treated with EI or SB. MAIN OUTCOME MEASUREMENTS: Objective and subjective results were compared with baseline and 1, 3, and 6 months after the first treatment. Complications of both treatments were noted. Primary endpoints after 6 months were the mean number of dilation sessions and success rate (percentage of patients with < or =5 dilations in 6 months). Study participation ended after 6 months or if dysphagia grades II to IV recurred despite 5 treatment sessions. RESULTS: No complications occurred with both treatments. There was no significant difference between the EI and SB groups in the mean number of dilations (2.9; 95% CI, 2.7-4.1 vs 3.3; 95% CI, 2.3-3.6l; P = .46) or the success rate (80.6% vs 67.7%, P = .26 and 96.2% vs 80.8%, P = .19). LIMITATIONS: In a small study with negative primary endpoints, secondary endpoints and subgroup analyses are hypothesis generating only. CONCLUSIONS: This prospective trial demonstrated that EI of gastroesophageal anastomotic strictures is a safe therapy and equivalent to SB as a primary therapy. EI can be used as an alternative or additional therapy to SB. (Registered with Current Controlled Trials, Ltd, registration number ISRCTN81239664.).
RCT Entities:
BACKGROUND:Benign gastroesophageal anastomotic strictures are common and often refractory to treatment. Various endoscopic dilation techniques have been reported, but none of these methods has been proven to be superior. OBJECTIVE: Comparison of the efficacy and safety of dilation of previously untreated anastomotic strictures by using electrocautery incision (EI) and Savary bougienage (SB). DESIGN: Randomized, prospective study. SETTING: Multicenter study. PATIENTS: Sixty-two patients with an anastomotic stricture after esophagogastrostomy and dysphagia Atkinson grades II to IV were included. INTERVENTIONS:Patients were treated with EI or SB. MAIN OUTCOME MEASUREMENTS: Objective and subjective results were compared with baseline and 1, 3, and 6 months after the first treatment. Complications of both treatments were noted. Primary endpoints after 6 months were the mean number of dilation sessions and success rate (percentage of patients with < or =5 dilations in 6 months). Study participation ended after 6 months or if dysphagia grades II to IV recurred despite 5 treatment sessions. RESULTS: No complications occurred with both treatments. There was no significant difference between the EI and SB groups in the mean number of dilations (2.9; 95% CI, 2.7-4.1 vs 3.3; 95% CI, 2.3-3.6l; P = .46) or the success rate (80.6% vs 67.7%, P = .26 and 96.2% vs 80.8%, P = .19). LIMITATIONS: In a small study with negative primary endpoints, secondary endpoints and subgroup analyses are hypothesis generating only. CONCLUSIONS: This prospective trial demonstrated that EI of gastroesophageal anastomotic strictures is a safe therapy and equivalent to SB as a primary therapy. EI can be used as an alternative or additional therapy to SB. (Registered with Current Controlled Trials, Ltd, registration number ISRCTN81239664.).