Delayed Gastric Conduit Emtpying (DGCE), Minimally-invasive Esophagectomy
Conditions
Keywords
Balloon dilatation, intraoperatively, ivor lewis Esophagectomy, Delayed gastric conduit emtpying (DGCE)
Brief summary
Background: Esophageal carcinoma ranks among the most common and lethal cancers worldwide. Minimally invasive esophagectomy is the standard curative treatment, but postoperative delayed gastric conduit emptying (DGCE) remains a major complication, occurring in up to 40% of patients. DGCE prolongs recovery, increases morbidity, and raises healthcare costs. Mechanical stretching of the pylorus has shown potential to reduce DGCE in retrospective studies, but evidence from randomized controlled trials in the context of minimally invasive surgery is lacking. Objective: The WIDE Trial aims to evaluate whether intraoperative endoscopic balloon dilation of the pylorus during minimally invasive Ivor-Lewis esophagectomy can reduce the incidence of early postoperative DGCE, improve recovery, and enhance quality of life. Design: This is a prospective, single-center, double-blinded, superiority randomized controlled trial conducted at Clarunis University Digestive Health Care Center, Basel. A total of 116 patients with histologically confirmed esophageal carcinoma undergoing minimally invasive esophagectomy with curative intent will be randomized 1:1 into an intervention group and a control group. Intervention group: Intraoperative endoscopic balloon dilatation of the pylorus to 30 mm before gastric conduit formation. Control group: Standard minimally invasive Ivor Lewis esophagectomy without dilatation. Endpoints: Primary endpoint: Incidence of early DGCE within 14 days postoperatively, defined by radiological and clinical criteria (gastric tube output \>500 mL on day ≥5 or \>100% increase in gastric tube width on X-ray). Secondary endpoints: Late DGCE incidence (after \>14 days), anastomotic leak rate, overall postoperative complications (Clavien-Dindo classification), hospital stay, time to first bowel movement, time to solid food intake, and postoperative quality of life (EORTC QLQ-OES18). Methods and Follow-up: Baseline data are collected preoperatively; postoperative outcomes are assessed at days 5, 10, and 3 months. Ward physicians and radiologists assessing outcomes are blinded to group assignment. At three months, all patients undergo follow-up including symptom questionnaires, radiological passage study, and QoL assessment. Statistics: Power analysis (α = 0.05, β = 0.20) based on prior studies suggests that 52 patients per group are needed to detect a reduction in DGCE incidence from 48% to 22%. Accounting for 10% attrition, 116 total patients will be enrolled. Analyses will follow the intention-to-treat principle using chi-square, t-tests/Mann-Whitney U tests, and multivariable logistic regression to adjust for confounders. Risk-Benefit Assessment: The intervention poses minimal additional risk, as balloon dilatation is an established and safe endoscopic procedure, adding approximately 20-30 minutes to surgical time. Possible complications such as perforation or bleeding are rare and manageable intraoperatively. Potential benefits include reduced DGCE incidence, shorter hospitalization, lower complication rates, and improved patient quality of life. Ethics and Data Protection: The study complies with the Declaration of Helsinki, ICH-GCP, and Swiss ClinO regulations (risk category A). All participants provide written informed consent. Patient data are pseudonymized and securely stored in a REDCap database. Timeline: Start of recruitment: December 2025 End of recruitment / last surgery: June 2028 Follow-up: 3 months per patient postoperatively Expected Impact: If intraoperative endoscopic pylorus dilatation proves effective, it could become a new standard adjunct procedure in minimally invasive esophagectomy, reducing DGCE-related morbidity and improving recovery and cost-efficiency in esophageal cancer surgery.
Interventions
PROCEDUREendoscopic plyoric balloon dilatation performed by experienced gastroenterologists
Standard endoscopic plyoric balloon dilatation performed by experienced gastroenterologists as it would be performed to treat DGCE
Sponsors
University Hospital, Basel, Switzerland
University Digestive Health Care Center Basel, Clarunis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Early Delayed Gastric Conduit Emptying (DGCE) on day 5 and 10 | On postoperative day 5 and day 10 after the Intervention and the day of the esophagectomy. | Early DGCE is defined as: \>500ml output of the nasogastric tube OR \>100% increased gastric tube width on frontal X-Ray. If either one of the mentioned parameters is fullfilled DGCE is present. The Incidence of DGCE is our primary outcome and it is defined by one of the above mentioned criteria. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Late DGCE | Data will be collected 3 months after the intervention | After 3 months postoperatively (after the Intervention) patients are asked to fill out the DGCE symptom questionnaire and a radiological passage will be performed after 3 months to assess the passage of the contrast agent trough the GI-System. Late DGCE is defined as: quite a bit or very much of at least 2 of 5 symptoms in the DGCE Quesitonniare and a verdict by the radiologist "delayed contrast passage". |
| Demographics | Demographic data will be collected prior to the Intervention on day X before the surgery in the surgical consultation, where patients provide the informed consent to participate in the study. | Demographical data: age, gender are collected for comparison of the results and potential confounders. |
| Weight | Baseline Day of the Intervention (Before the Intervention) | Body weight in kilograms at the time of the preoperative anesthesia consultation will be recorded |
| Perioperative parameters | Data will be collected 3 months after the intervention | Data concerning hospital and ICU stay (in days after Intervention) are collected for later analysis. |
| Past medical history | Demographic data and past medical history will be collected prior to the Intervention on day X before the surgery in the surgical consultation, where patients provide the informed consent to participate in the study. | Past medical history are noted for comparison of the results and potential confounders. |
| Rate of anastomotic leak | Data will be collected 3 months after the intervention | The anastomotic leak rate (diagnosed by endoscopy) will be recorded |
| Complication rate | Data will be collected 3 months after the intervention | All patients' complication rates will be recorded for comparison |
| First bowel movement | At discharge (assessed up to 5 days) | Time (in days) till first bowel movement after the operation is recorded |
| Postoperative quality of life | Data is collected 3 months after the intervention | Postoperative quality of life will be assessed using the EORTC QLQ-OES18 questionnaire. Between 18 and 72 points can be reached. Higher scores indicate stronger symptoms and therefore lower quality of life |
Countries
Switzerland
Contacts
CONTACTLucien Cron, cand. med
STUDY_DIRECTORBeat Müller, Prof.
Clarunis, University digestive health care centre basel
Outcome results
None listed