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Delayed Gastric Conduit Emtpying (DGCE)WIDENCT07355374

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

A study testing endoscopic plyoric balloon dilatation performed by experienced gastroenterologists in people with Delayed Gastric Conduit Emtpying (DGCE) and Minimally-invasive Esophagectomy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
endoscopic plyoric balloon dilatation performed by experienced gastroenterologists
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
116 participants
Where
1 siteSwitzerland
Study dates
15 Dec 2025to 1 Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age >18 years
  • Histologically confirmed esophageal cancer
  • Planned surgical resection in curative intent as a minimally invasive Ivor Lewis procedure
  • Provided informed consent

Who cannot join

  • Prior esophageal or gastric resection
  • Non-curative intent of surgery
  • ASA Score V
  • Patients lacking capacity to provide informed consent

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lucien Cron, cand. med contact

061 777 75 02 ext. +41

lucien.cron@clarunis.ch

Switzerland1 site, 1 recruiting
  • Clarunis University Digestive Health Care Center Basel

    Basel, Canton of Basel-City, 4058

    Lucien Cron, Resident, +41617777502, lucien.cron@clarunis.ch

    Jennifer Klasen, PD. Dr. Med, +41617777513, jennifer.klasen@clarunis.ch

    Recruiting

Other trials in Switzerland

About this study

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

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.

Read more

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.

Being tested
endoscopic plyoric balloon dilatation performed by experienced gastroenterologists
Keywords
Balloon dilatation, intraoperatively, ivor lewis Esophagectomy, Delayed gastric conduit emtpying (DGCE)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • endoscopic plyoric balloon dilatation performed by experienced gastroenterologistsProcedure or surgery

    Standard endoscopic plyoric balloon dilatation performed by experienced gastroenterologists as it would be performed to treat DGCE

Study groups in NCT07355374
Study groupRoleWhat they receive
Dilation GroupActive comparatorIntervention group; patients receive additional dilation of the pylorus
Receives: Procedure: endoscopic plyoric balloon dilatation performed by experienced gastroenterologists
ControlNo interventionIn this group patients will undergo standard care without additional intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: On postoperative day 5 and day 10 after the Intervention and the day of the esophagectomy.

Secondary outcomes (9)
  1. 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".

    Measured: Data will be collected 3 months after the intervention

  2. Demographics

    Demographical data: age, gender are collected for comparison of the results and potential confounders.

    Measured: 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.

  3. Weight

    Body weight in kilograms at the time of the preoperative anesthesia consultation will be recorded

    Measured: Baseline Day of the Intervention (Before the Intervention)

  4. Perioperative parameters

    Data concerning hospital and ICU stay (in days after Intervention) are collected for later analysis.

    Measured: Data will be collected 3 months after the intervention

  5. Past medical history

    Past medical history are noted for comparison of the results and potential confounders.

    Measured: 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.

  6. Rate of anastomotic leak

    The anastomotic leak rate (diagnosed by endoscopy) will be recorded

    Measured: Data will be collected 3 months after the intervention

  7. Complication rate

    All patients' complication rates will be recorded for comparison

    Measured: Data will be collected 3 months after the intervention

  8. First bowel movement

    Time (in days) till first bowel movement after the operation is recorded

    Measured: At discharge (assessed up to 5 days)

  9. 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

    Measured: Data is collected 3 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Jan 2026
  2. Study start15 Dec 2025
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion1 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
116 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07355374
Sponsor's protocol ID
2025-01877
Other IDs
2025
Acronym
WIDE
Status last verified
Mar 2026
First submitted
14 Nov 2025
Last updated
25 Mar 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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.

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.

    PubMed 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.

    PubMed 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, 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.

    PubMed 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.

    PubMed 42082244

Questions about this trial

What is this clinical trial studying?

A study testing endoscopic plyoric balloon dilatation performed by experienced gastroenterologists in people with Delayed Gastric Conduit Emtpying (DGCE) and Minimally-invasive Esophagectomy, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lucien Cron, cand. med (061 777 75 02 ext. +41, lucien.cron@clarunis.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07355374, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2026.

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