Reconstruction With a Lawrence-Hunt Jejunal Pouch After Total Gastrectomy
NCT ID: NCT06967571
Last Updated: 2026-01-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
26 participants
INTERVENTIONAL
2025-06-01
2028-04-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Open or laparoscopic TG followed by JP reconstruction.
All participants will undergo open or laparoscopic Total Gastrectomy (TG) followed by Jejunal Pouch (JP) reconstruction.
Jejunal Pouch reconstruction.
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
Interventions
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Jejunal Pouch reconstruction.
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
75 Years
ALL
No
Sponsors
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
OTHER
Responsible Party
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Principal Investigators
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Annamaria Agnes, MD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Locations
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Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, , Italy
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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7445
Identifier Type: -
Identifier Source: org_study_id
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