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New pouch surgery aims to ease dumping syndrome after stomach removal

NCT ID NCT06967571

Symptom relief Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study tests a surgical technique called a jejunal pouch in 26 adults who need their entire stomach removed due to cancer or a high-risk gene mutation. The pouch is created from a section of the small intestine to replace the stomach's reservoir function. The goal is to reduce dumping syndrome—a common complication causing nausea, diarrhea, and dizziness after eating—and improve overall quality of life and nutrition.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Jejunal pouch reconstruction (a surgical procedure)
What this could lead to
If successful, this surgical technique could reduce dumping syndrome and improve nutrition and quality of life after total stomach removal.
What could go wrong
This is a small, early-phase trial with only 26 participants, so results may not apply broadly. Surgery carries risks like infection or leakage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 26 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Adults aged 18-75 years. * Histologically confirmed gastric tumor (including adenocarcinoma, gastrointestinal stromal tumor - GIST- or neuroendocrine tumor) or patients with CDH1 mutation, scheduled for TG with a maximal esophageal resection of \< 6 cm. * Informed consent capability. Exclusion Criteria: * Prior abdominal surgeries affecting the jejunum. * Severe comorbidities or non-appropriate organ function: uncontrolled diabetes with HbA1C \> 7.5, significant heart disease: New York Heart Association (NYHA) functional classification Class III or IV, chronic obstructive pulmonary disease (COPD) requiring oxygen supplementation or continuous positive airway pressure (CPAP), chronic corticosteroid therapy (daily for more than 6 months), neutrophil count \< 2000/mm3, hemoglobin \< 8.0 g/dL, platelet count \< 100,000/mm3, serum total bilirubin \> 1.5 mg/dL, serum aspartate aminotransferase (AST) \>100 IU/L, serum alanine aminotransferase (ALT) \>100 IU/L, and creatinine clearance (CCr) ≥ 50 mL/min), ECOG performance status \> 1. * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

gastric adenocarcinoma gastric cancer gastric neoplasm gastric neuroendocrine tumor, well differentiated, low or intermediate grade gastrointestinal stromal tumor hereditary diffuse gastric adenocarcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gastric cancer Total gastrectomy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    RECRUITING

    Roma, Italy

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