Reconstruction With a Lawrence-Hunt Jejunal Pouch After Total Gastrectomy

NCT06967571 | Active Not Recruiting

• 1 other identifier: 7445
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Gastrectomy; Gastric Cancer

Keywords

gastric cancer; total gastrectomy

Outcome Measures

Primary Outcomes (1)

• Dumping syndrome reduction rate

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

  12 months after surgery

Secondary Outcomes (8)

• Dumping syndrome severity

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

• Nutritional status - weight

  3, 6 & 12 months after surgery

• Nutritional status - height

  3, 6 & 12 months after surgery

• Nutritional status - Body Mass Index (BMI)

  3, 6 & 12 months after surgery

• Nutritional status

  3, 6 & 12 months after surgery

Study Arms (1)

Open or laparoscopic TG followed by JP reconstruction.

EXPERIMENTAL

All participants will undergo open or laparoscopic Total Gastrectomy (TG) followed by Jejunal Pouch (JP) reconstruction.

Procedure: Jejunal Pouch reconstruction.

Interventions

Jejunal Pouch reconstruction. PROCEDURE

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

Open or laparoscopic TG followed by JP reconstruction.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

Location

Related Publications (10)

• 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.

  PMID: 32703713 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• 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.

  PMID: 32151595 RESULT

• 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.

  PMID: 31082900 RESULT

• 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.

  PMID: 26682541 RESULT

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Annamaria Agnes, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: May 13, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)