Effect of dilating the gastro-esophageal junction on prolonged dysphagia after anti-reflux operation.

Rationale: The prevalence of gastroesophageal reflux disease (GERD) is 10-20% in the western world. Typical symptoms are heartburn and regurgitation. The most effective treatment is laparoscopic fundoplication, in which the fundus of the stomach (partially) placed around the distal esophagus. Postoperative dysphagia is usually self-limiting within 2-6 weeks. In 5-10% of patients however, prolonged dysphagia is seen (> 3 months postoperatively). Treatment options are an expectative approach or dilation of the lower esophageal sphincter and surgically constructed wrap around it. Pneumodilation (PD) is generally believed to be the most effective dilatation technique, but it has never been shown that dilation of the LES and wrap is actually more effective than the expectative approach.

Objective: To evaluate the effect of pneumodilatation (PD) on prolonged dysphagia after Toupet or Nissen fundoplication compared to sham dilatation.
Study design: This is an interventional, multicentre trial. Either pneumodilatation or sham dilation is performed in a randomized, single-blinded manner.

Study population: 42 adult patients with prolonged dysphagia (> 3 months) after primary Nissen or Toupet fundoplication for GERD.

Intervention: In one group a pneumodilatation is performed and in the other group a sham dilatation (endoscopy without intervention) is performed .
Main study endpoints: Dysphagia symptom severity (Eckardt score).

The aim of the study is to compare the efficacy of pneumodilatation with 'sham'-treatment (placebo intervention). It is hypothesized that pneumodilatation will resolve dysphagia faster than sham dilatation.

Baseline: high-resolution manometry, barium esophagography, informed consent, questionnaires

Day 1 (visit 1): Endoscopy with pneumodilatation or sham dilatation



Day 7: Questionnaires by telephone or mail.



Day 30 (visit 2): high-resolution manometry, barium esophagography, questionnaires



Questionnaires are: Eckardt score, Short form-36 (health related quality of life), Reflux disease questionnare (RDQ), Impaction dysphagia questionnaire (IDQ)

Patients with persistent dysphagia more than 3 months postoperatively will be randomized to either pneumatic dilatation or to sham dilatation.

Pneumatic dilatation: During endoscopy under sedation. The Rigiflex 35 mm balloon will be positioned in the lower esophageal sphincter (LES) area (x-rays can be used or this can be done under direct endoscopic guidance) and inflated to 35mm at 8 psi and maintained until the “waist” of the balloon is obliterated, or for at least one minute.



Sham dilatation: This endoscopy will also be performed under sedation. However, no dilatation or other intervention will be performed.



The patient is blinded to the treatment.



Participating sites:

- Academic Medical Center, Amsterdam

- Meander Medical Center, Amersfoort

- University Hospital Leuven, Leuven

- Maastricht University Medical Center, Maastricht

- St Antonius Hospital, Nieuwegein