Pyloric balloon dilation during minimally invasive Ivor‑Lewis esophagectomy to reduce delayed gastric conduit emptying
Patients With Esophageal Carcinoma Undergoing Minimally Invasive Ivor Lewis Esophagectomy With or Without Intraoperative Endoscopic Pylorus Balloon Dilation: A Randomized Controlled Trial Investigating the Benefits of Intraoperative Endoscopic Pylorus Dilation
This trial will see if a brief endoscopic balloon dilation of the pylorus during minimally invasive Ivor‑Lewis esophagectomy reduces early delayed gastric conduit emptying in adults having surgery for esophageal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT07355374 on ClinicalTrials.gov |
What this trial studies
The WIDE Trial is a prospective, single‑center, double‑blinded, randomized controlled trial at Clarunis University Digestive Health Care Center in Basel. Adults scheduled for curative minimally invasive Ivor‑Lewis esophagectomy are randomized to receive intraoperative endoscopic pyloric balloon dilation performed by experienced gastroenterologists or the control procedure. The primary outcome is the incidence of early postoperative delayed gastric conduit emptying (DGCE), with secondary assessments of recovery metrics and quality of life. Follow‑up at the center captures postoperative complications and functional outcomes.
Who should consider this trial
Good fit: Adults over 18 with histologically confirmed esophageal cancer scheduled for curative minimally invasive Ivor‑Lewis esophagectomy who can provide informed consent.
Not a fit: Patients with prior esophageal or gastric resections, those undergoing non‑curative surgery, patients with ASA V, or those unable to consent are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the procedure could lower the rate of early DGCE, speed recovery after surgery, and reduce related complications and healthcare costs.
How similar studies have performed: Retrospective and nonrandomized reports have suggested that mechanical pyloric stretching may reduce DGCE, but randomized evidence in the minimally invasive Ivor‑Lewis setting is currently lacking.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 years * Histologically confirmed esophageal cancer * Planned surgical resection in curative intent as a minimally invasive Ivor Lewis procedure * Provided informed consent Exclusion Criteria: * Prior esophageal or gastric resection * Non-curative intent of surgery * ASA Score V * Patients lacking capacity to provide informed consent
Where this trial is running
Basel, Canton of Basel-City
- Clarunis University Digestive Health Care Center Basel — Basel, Canton of Basel-City, Switzerland (Recruiting)
Study contacts
- Study coordinator: Lucien Cron, cand. med
- Email: lucien.cron@clarunis.ch
- Phone: 061 777 75 02
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.