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

Official title

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

Overview

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

• 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

Primary outcome measures

• Incidence of Early Delayed Gastric Conduit Emptying (DGCE) on day 5 and 10 [Time frame: On postoperative day 5 and day 10 after the Intervention and the day of the esophagectomy.]

Secondary outcome measures (9)

• Incidence of Late DGCE [Time frame: Data will be collected 3 months after the intervention]
• Demographics [Time frame: 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 [Time frame: Baseline Day of the Intervention (Before the Intervention)]
• Perioperative parameters [Time frame: Data will be collected 3 months after the intervention]
• Past medical history [Time frame: 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 [Time frame: Data will be collected 3 months after the intervention]
• Complication rate [Time frame: Data will be collected 3 months after the intervention]
• First bowel movement [Time frame: At discharge (assessed up to 5 days)]
• Postoperative quality of life [Time frame: Data is collected 3 months after the intervention]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Switzerland · 1 center

• Clarunis University Digestive Health Care Center Basel — Basel

Publications

• 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. PMID 29846516
• 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. PMID 35178557
• 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, V PMID 31608938
• Cron L, Klasen JM, Neuschutz K, Dirnberger A, Maaser A, Baur J, Heinrich H, Gockel I, Bolli M, Muller BP, Kraljevic M. Intraoperative endoscopic pylorus dilatation during minimally invasive Ivor Lewis oesophagectomy to prevent delayed gastric conduit emptying (DGCE): protocol for the WIDE randomised controlled trial. BMJ Open. 2026 May 3;16(4):e117280. doi: 10.1136/bmjopen-2026-117280. PMID 42082244

Identifiers

NCT: NCT07355374 · 2025-01877

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗