Balloon Dilation in Patients Undergoing Minimally Invasive Ivor Lewis Esophagectomy and Its Effect on Reducing DGCE (WIDE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Delayed Gastric Conduit Emtpying (DGCE); Minimally-invasive Esophagectomy
• Intervention / Treatment: Procedure: endoscopic plyoric balloon dilatation performed by experienced gastroenterologists

• Study Type: Interventional
• Enrollment (Estimated): 116
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucien Cron, cand. med; Phone Number: +41 061 777 75 02; Email: lucien.cron@clarunis.ch

Study Locations

• Switzerland
  • Canton of Basel-City
    • Basel, Canton of Basel-City, Switzerland, 4058
      • Recruiting
      • Clarunis University Digestive Health Care Center Basel
      • Contact: Lucien Cron, Resident; Phone Number: +41617777502; Email: lucien.cron@clarunis.ch
      • Contact: Jennifer Klasen, PD. Dr. Med; Phone Number: +41617777513; Email: jennifer.klasen@clarunis.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dilation Group; Intervention group; patients receive additional dilation of the pylorus	Procedure: endoscopic plyoric balloon dilatation performed by experienced gastroenterologists; Standard endoscopic plyoric balloon dilatation performed by experienced gastroenterologists as it would be performed to treat DGCE
No Intervention: Control; In this group patients will undergo standard care without additional intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Early Delayed Gastric Conduit Emptying (DGCE) on day 5 and 10	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.	On postoperative day 5 and day 10 after the Intervention and the day of the esophagectomy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Late DGCE	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".	Data will be collected 3 months after the intervention
Demographics	Demographical data: age, gender are collected for comparison of the results and potential confounders.	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.
Weight	Body weight in kilograms at the time of the preoperative anesthesia consultation will be recorded	Baseline Day of the Intervention (Before the Intervention)
Perioperative parameters	Data concerning hospital and ICU stay (in days after Intervention) are collected for later analysis.	Data will be collected 3 months after the intervention
Past medical history	Past medical history are noted for comparison of the results and potential confounders.	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.
Rate of anastomotic leak	The anastomotic leak rate (diagnosed by endoscopy) will be recorded	Data will be collected 3 months after the intervention
Complication rate	All patients' complication rates will be recorded for comparison	Data will be collected 3 months after the intervention
First bowel movement	Time (in days) till first bowel movement after the operation is recorded	At discharge (assessed up to 5 days)
Postoperative quality of life	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	Data is collected 3 months after the intervention

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: University Digestive Health Care Center Basel, Clarunis
• Investigators: Study Director: Beat Müller, Prof., Clarunis, University digestive health care centre basel

Publications and helpful links

General Publications

• Konradsson M, van Berge Henegouwen MI, Bruns C, Chaudry MA, Cheong E, Cuesta MA, Darling GE, Gisbertz SS, Griffin SM, Gutschow CA, van Hillegersberg R, Hofstetter W, Holscher AH, Kitagawa Y, van Lanschot JJB, Lindblad M, Ferri LE, Low DE, Luyer MDP, Ndegwa N, Mercer S, Moorthy K, Morse CR, Nafteux P, Nieuwehuijzen GAP, Pattyn P, Rosman C, Ruurda JP, Rasanen J, Schneider PM, Schroder W, Sgromo B, Van Veer H, Wijnhoven BPL, Nilsson M. Diagnostic criteria and symptom grading for delayed gastric conduit emptying after esophagectomy for cancer: international expert consensus based on a modified Delphi process. Dis Esophagus. 2020 Apr 15;33(4):doz074. doi: 10.1093/dote/doz074.
• Boshier PR, Adam ME, Doran S, Muthuswamy K, Hanna GB. Effects of intraoperative pyloric stretch procedure on outcomes after esophagectomy. Dis Esophagus. 2018 Oct 1;31(10). doi: 10.1093/dote/doy038.
• Nienhuser H, Heger P, Crnovrsanin N, Schaible A, Sisic L, Fuchs HF, Berlth F, Grimminger PP, Nickel F, Billeter AT, Probst P, Muller-Stich BP, Schmidt T. Mechanical stretching and chemical pyloroplasty to prevent delayed gastric emptying after esophageal cancer resection-a meta-analysis and review of the literature. Dis Esophagus. 2022 Jul 12;35(7):doac007. doi: 10.1093/dote/doac007.

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2025
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 24, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Balloon dilatation; intraoperatively; ivor lewis Esophagectomy; Delayed gastric conduit emtpying (DGCE)
• Other Study ID Numbers: 2025-01877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: The data will be shared in an anonymized manner to protect participant privacy and prevent data breaches. Data sharing without pseudonymization is not permitted under Swiss ethical and regulatory requirements.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No