|- candidate number||22326|
|- NTR Number||NTR5247|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-jun-2015|
|- Secondary IDs||NL50376.018.14 |
|- Public Title||Effect of dilating the gastro-esophageal junction on prolonged dysphagia after anti-reflux operation.|
|- Scientific Title||Effect of pneumodilatation of the EGJ in patients with prolonged dysphagia
|- ACRONYM||DAFFODIL trial (Dysphagia After Fundoplication: eFfect Of Dilatation)|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Gastroesophageal reflux Disease (GERD), Pneumodilation, Dysphagia|
|- Inclusion criteria|| Patients after primary Nissen or Toupet fundoplication for GERD|
Dysphagia that was not present before surgery and lasting for at least 3 months
Eckardt symptom score ≥ 4
Written informed consent
Age above 18 years
|- Exclusion criteria|| Significant dysphagia before surgery |
Previous dilatation for dysphagia
History of (pseudo)achalasia
Anatomical defects causing dysphagia (slipped, malpositioned or
Allergy to barium sulfate
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-apr-2015|
|- planned closingdate||1-jun-2017|
|- Target number of participants||42|
|- Interventions||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.
- Academic Medical Center, Amsterdam
- Meander Medical Center, Amersfoort
- University Hospital Leuven, Leuven
- Maastricht University Medical Center, Maastricht
- St Antonius Hospital, Nieuwegein
|- Primary outcome||Dysphagia symptom severity (Eckardt score)|
|- Secondary outcome|| Reflux symptom severity (Reflux disease questionnaire; RDQ)|
Health related Quality of life (SF-36)
Impaction dysphagia questionnaire (IDQ)
Height and width of stasis on barium esophagogram after one minute
High-resolution manometry (LES pressure, IRP-4)
Adverse events / complications
Change in body weight
|- Timepoints||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)
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||Dr. A.J. Bredenoord|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A.J. Bredenoord|
|- Sponsor/Initiator ||Academic Medical Center (AMC), Amsterdam, University of Amsterdam (UvA)|
(Source(s) of Monetary or Material Support)
|Academic Medical Center (AMC), University of Amsterdam|
|- Brief summary||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).
|- Main changes (audit trail)|
|- RECORD||10-jun-2015 - 15-aug-2015|