Reconstruction With a Lawrence-Hunt Jejunal Pouch After Total Gastrectomy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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

Первичные конечные точки

• Dumping syndrome reduction rate [Срок оценки: 12 months after surgery]

Вторичные конечные точки (8)

• Dumping syndrome severity [Срок оценки: The DSS was administered at 3, 6, and 12 months after surgery.]
• Nutritional status - weight [Срок оценки: 3, 6 & 12 months after surgery]
• Nutritional status - height [Срок оценки: 3, 6 & 12 months after surgery]
• Nutritional status - Body Mass Index (BMI) [Срок оценки: 3, 6 & 12 months after surgery]
• Nutritional status [Срок оценки: 3, 6 & 12 months after surgery]
• Gastrointestinal Quality of Life Index (GIQLI) [Срок оценки: 3, 6 & 12 months after surgery]
• EORTC QLQ-C30 [Срок оценки: Assessments were performed at 3, 6, and 12 months after surgery]
• Postoperative complications [Срок оценки: 12 months after surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Италия · 1 центр

• Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma

Публикации

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• 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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: 10.1 PMID 32151595

Идентификаторы

NCT: NCT06967571 · 7445

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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