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Total GastrectomyREJOYNCT06967571

Reconstruction With a Lawrence-Hunt Jejunal Pouch After Total Gastrectomy

A study testing Jejunal Pouch reconstruction. in people with Total Gastrectomy and Gastric Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

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

The aim of the study is to establish the efficacy of jejunal pouch reconstruction in reducing dumping syndrome in patients undergoing total gastrectomy, ultimately enhancing postoperative quality of life and nutritional status. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Total Gastrectomy, Gastric Cancer
What is being tested?
Jejunal Pouch reconstruction.
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
26 participants
Where
1 siteItaly
Study dates
1 Jan 2026to 1 Apr 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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

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

Annamaria Agnes, MD contact

+39 0630167190

annamaria.agnes@policlinicogemelli.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma

    Annamaria Agnes, MD, annamaria.agnes@policlinicogemelli.it

    Recruiting

Other trials in Italy

About this study

Official title: Reconstruction With a Lawrence-Hunt Jejunal Pouch for Upfront Total Gastrectomy - Study Protocol of a Prospective, Single-arm, Phase II Trial

The aim of the study is to establish the efficacy of jejunal pouch reconstruction in reducing dumping syndrome in patients undergoing total gastrectomy, ultimately enhancing postoperative quality of life and nutritional status.

Read the detailed description

Total gastrectomy (TG) with Roux-en-Y (RY) esophageal-jejunal anastomosis is performed for various gastric malignancies or as a prophylactic strategy in patients with hereditary diffuse gastric cancer syndrome harboring CDH1 mutation at risk of developing gastric cancer. The surgical procedure is, however, complicated in the post-operative months by weight loss and nutritional deficiency in most patients, requiring frequent follow-up, and by functional issues such as reflux and dumping syndrome in about 30% of cases, which significantly impact the patient's quality of life. To prevent the poorer outcomes reported by patients undergoing total gastrectomy, one strategy could be a modification of the reconstruction method using a jejunal pouch reconstruction (JP) that may mitigate symptoms by slowing gastric emptying and enhancing nutrient absorption. JP has so far proven several benefits in improving postoperative outcomes (reflux and dumping syndrome), nutritional outcomes, and QoL up to 2 years after surgery. The technique has been mostly studied in the Eastern countries (Japan and South Korea) and, since 2021, has been recommended by the French Association of Surgery as the technique of choice for reconstruction after total gastrectomy. However, in most European centers, this technique has not yet been introduced as a routine procedure due to a relative lack of data on the clinical benefit and risk profile in the Western population.

Being tested
Jejunal Pouch reconstruction.
Keywords
gastric cancer, total gastrectomy
Medical subject headings
Stomach Neoplasms

What participants receive

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

  • Jejunal Pouch reconstruction.Procedure or surgery

    The JP will be fashioned with a standard length of 12 cm using two 60 mm staple lines, the esophago-pouch anastomosis will be performed with a circular mechanical 25 mm stapling device, and finally the staple entrance on the pouch will be closed with two layers of running sutures in Vicryl 3/0

Study groups in NCT06967571
Study groupRoleWhat they receive
Open or laparoscopic TG followed by JP reconstruction.ExperimentalAll participants will undergo open or laparoscopic Total Gastrectomy (TG) followed by Jejunal Pouch (JP) reconstruction.
Receives: Procedure: Jejunal Pouch reconstruction.

What is being measured

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

  1. Dumping syndrome reduction rate

    Evaluate the reduction in the incidence of dumping syndrome after TG with JP reconstruction with the Sigstad questionnaire.

    Measured: 12 months after surgery

Secondary outcomes (8)

  1. Dumping syndrome severity

    Dumping syndrome severity was assessed using the Arts Dumping Severity Score (DSS), an 11-item questionnaire with a total score range of 0-33, where higher scores indicate worse symptoms.

    Measured: The DSS was administered at 3, 6, and 12 months after surgery.

  2. Nutritional status - weight

    Assess the nutritional status using weight in kilograms

    Measured: 3, 6 & 12 months after surgery

  3. Nutritional status - height

    Assess the nutritional status using height in meters

    Measured: 3, 6 & 12 months after surgery

  4. Nutritional status - Body Mass Index (BMI)

    To Assess the nutritional status weight and height will be combined to report BMI in kg/m^2

    Measured: 3, 6 & 12 months after surgery

  5. Nutritional status

    Assess the nutritional status using validated metrics such as the serum iron levels, albumin levels, B12 levels and vitamin D levels.

    Measured: 3, 6 & 12 months after surgery

  6. Gastrointestinal Quality of Life Index (GIQLI)

    Evaluate the quality of life using using the Italian versions of the GIQLI questionnaire. The maximum GIQLI in the international score is 144 and its worst value is 0.

    Measured: 3, 6 & 12 months after surgery

  7. EORTC QLQ-C30

    Quality of life was assessed using the Italian version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire - Core 30 (EORTC QLQ-C30). All scales were transformed into scores ranging from 0 to 100. For the functional scales and the global health status/quality of life scale, higher scores indicate a better outcome, whereas for the symptom scales higher scores indicate greater symptom severity.

    Measured: Assessments were performed at 3, 6, and 12 months after surgery

  8. Postoperative complications

    Measure the rate of postoperative complications. All severe adverse events (SAEs) will be collected starting with the surgical admission until the end of the study period (12 months).

    Measured: 12 months after surgery

Timeline

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

  1. First posted13 May 2025
  2. Study start1 Jan 2026
  3. Primary completion1 Jan 2028 (estimated)
  4. Study completion1 Apr 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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06967571
Sponsor's protocol ID
7445
Acronym
REJOY
Status last verified
Jul 2026
First submitted
19 Mar 2025
Last updated
23 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Trapani R, Rausei S, Reddavid R, Degiuli M; ITALIAN RESEARCH GROUP FOR GASTRIC CANCER (GIRCG) Clinical Investigators. Risk factors for esophago-jejunal anastomosis leakage after total gastrectomy for cancer. A multicenter retrospective study of the Italian research group for gastric cancer. Eur J Surg Oncol. 2020 Dec;46(12):2243-2247. doi: 10.1016/j.ejso.2020.06.035. Epub 2020 Jul 9.

    PubMed 32703713

  • A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med. 2001 Mar 30;20(6):859-66. doi: 10.1002/sim.721.

    PubMed 11252008

  • Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

    PubMed 15273542

  • Apolone G, Filiberti A, Cifani S, Ruggiata R, Mosconi P. Evaluation of the EORTC QLQ-C30 questionnaire: a comparison with SF-36 Health Survey in a cohort of Italian long-survival cancer patients. Ann Oncol. 1998 May;9(5):549-57. doi: 10.1023/a:1008264412398.

    PubMed 9653497

  • Ponticelli C, Colombo D, Novara M, Basilisco G; CETRA Study Group. Gastrointestinal symptoms impair quality of life in Italian renal transplant recipients but are under-recognized by physicians. Transpl Int. 2010 Nov;23(11):1126-34. doi: 10.1111/j.1432-2277.2010.01115.x. Epub 2010 Aug 19.

    PubMed 20525020

  • Scarpellini E, Arts J, Karamanolis G, Laurenius A, Siquini W, Suzuki H, Ukleja A, Van Beek A, Vanuytsel T, Bor S, Ceppa E, Di Lorenzo C, Emous M, Hammer H, Hellstrom P, Laville M, Lundell L, Masclee A, Ritz P, Tack J. International consensus on the diagnosis and management of dumping syndrome. Nat Rev Endocrinol. 2020 Aug;16(8):448-466. doi: 10.1038/s41574-020-0357-5. Epub 2020 May 26.

    PubMed 32457534

  • Sigstad H. A clinical diagnostic index in the diagnosis of the dumping syndrome. Changes in plasma volume and blood sugar after a test meal. Acta Med Scand. 1970 Dec;188(6):479-86. No abstract available.

    PubMed 5507449

  • Voron T, Romain B, Bergeat D, Veziant J, Gagniere J, Le Roy B, Pasquer A, Eveno C, Gaujoux S, Pezet D, Gronnier C; sous l'egide de l'Association francaise de chirurgie (AFC); Collaborateurs (relecteurs). Surgical management of gastric adenocarcinoma. Official expert recommendations delivered under the aegis of the French Association of Surgery (AFC). J Visc Surg. 2020 Apr;157(2):117-126. doi: 10.1016/j.jviscsurg.2020.02.006. Epub 2020 Mar 6.

    PubMed 32151595

  • Syn NL, Wee I, Shabbir A, Kim G, So JB. Pouch Versus No Pouch Following Total Gastrectomy: Meta-analysis of Randomized and Non-randomized Studies. Ann Surg. 2019 Jun;269(6):1041-1053. doi: 10.1097/SLA.0000000000003082.

    PubMed 31082900

  • Tanizawa Y, Tanabe K, Kawahira H, Fujita J, Takiguchi N, Takahashi M, Ito Y, Mitsumori N, Namikawa T, Oshio A, Nakada K; Japan Postgastrectomy Syndrome Working Party. Specific Features of Dumping Syndrome after Various Types of Gastrectomy as Assessed by a Newly Developed Integrated Questionnaire, the PGSAS-45. Dig Surg. 2016;33(2):94-103. doi: 10.1159/000442217. Epub 2015 Dec 18.

    PubMed 26682541

Questions about this trial

What is this clinical trial studying?

A study testing Jejunal Pouch reconstruction. in people with Total Gastrectomy and Gastric Cancer, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

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 3 inclusion and 3 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 23 Jul 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 Italy. 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 Annamaria Agnes, MD (+39 0630167190, annamaria.agnes@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dumping syndrome reduction rate (time frame: 12 months after surgery). 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 NCT06967571, which also lists 10 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 23 Jul 2026.

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