Application of a New Surgical Technique in Proximal Gastrectomy: a Prospective, Multicenter Randomized Controlled Study

Официальное название

Application of Hao's Esophagogastrostomy by Fissure Technique: a Prospective, Multicenter Randomized Controlled Study

Обзор

This is a prospective study using a multicenter, randomized, controlled, open label, and efficacy validated approach.At present, there is no universally recognized optimal method for gastrointestinal reconstruction after proximal gastrectomy in the surgical treatment of gastric cancer.Author's team has proposed an innovative method named Hao's Esophagogastrostomay by Fisture Technique (HEFT).By adding anti reflux structures such as "false gastric fundus" and "false cardia" to the anastomosis of the residual stomach of the esophagus, not only can the purpose of anti reflux be achieved, but also the normal physiological channel can be maintained, it can fully utilize residual stomach function and reduce the difficulty of surgery.Through retrospective research, our single center has confirmed that HEFT is safe and feasible.On this basis, this study will compare the nutritional status, short- and medium- to long-term safety after laparoscopic HEFT and double-tract reconstruction , in order to evaluate and discover more reasonable digestive tract reconstruction methods after proximal gastrectomy, and to promote the development and popularization of minimally treatment technology for gastric cancer. This study was jointly conducted by Shanghai-level hospitals (Huashan Hospital ,Shanghai Cancer Center, and Ruijin Hospital), with Huashan Hospital as the leading unit. This study will recruit 52 patients, with 26 patients in the experimental group and 26 patients in the control group. Using a central dynamic randomization method based on minimization, patients are assigned to groups in a 1:1 ratio. Based on the different anastomotic methods used in proximal gastrectomy, patients are divided into a HEFT group (experimental group) and a double-tract reconstruction group (control group).Plan to collect cases for 2 years, and follow up for another year after the last case is enrolled. The primary endpoint of the study was the body weight loss (BWL) rate at 1 year after surgery. Secondary endpoints: Effect evaluation indicators: hemoglobin level at 1 year after surgery; Serum albumin level at 1 year after surgery; The incidence of anastomotic stenosis 1 year after surgery; Incidence of reflux esophagitis at 1 year after surgery. Evaluation of short-term surgical safety (duration: 7 days): operation time, intraoperative bleeding, anastomotic leakage, pancreatic leakage, and incidence of abdominal infection; Evaluation of medium- and long-term safety after surgery (duration: 36 months): overall survival rate at 3 years after surgery; disease-free survival rate at 3 years after surgery.

Вмешательства

• Процедура Totally laparoscopic proximal gastrectomy with Hao's esophagogastrostomy by fissure technique
  This is an innovative surgical method applied in proximal gastrectomy. By adding anti reflux structures such as "false gastric fundus" and "false cardia" on the basis of esophageal residual gastric anastomosis, the goal of anti reflux is achieved, while maintaining normal physiological channels and fully utilizing residual gastric function, reducing the difficulty of proximal gastrectomy surgery
• Процедура Totally laparoscopic proximal gastrectomy with double-tract reconstruction
  This is a traditional surgical method that has been widely used in proximal gastrectomy. After disconnecting the proximal stomach, performing Roux-en-Y anastomosis of the esophagus and jejunum firstly, followed by lateral anastomosis of the residual stomach and jejunum. Previous studies have confirmed its safety and effectiveness, but there are also issues of gastric channel disuse and high missed detection rate of residual stomach.

Первичные конечные точки

• body weight loss（BWL） [Срок оценки: From enrollment to 1 year after surgery]

Вторичные конечные точки (11)

• Hemoglobin 1 year after surgery [Срок оценки: 1 year after surgery]
• Serum albumin 1 year after surgery [Срок оценки: 1 year after surgery]
• Incidence of anastomotic stenosis 1 year after surgery [Срок оценки: 1 year after surgery]
• Incidence of reflux esophagitis 1 year after surgery [Срок оценки: 1 year after surgery]
• Duration of surgery [Срок оценки: intraoperative]
• Intraoperative blood loss [Срок оценки: Intraoperative]
• Incidence of anastomotic leakage 7 days after surgery [Срок оценки: 7 days after surgery]
• Incidence of pancreatic leakage 7 days after surgery [Срок оценки: 7 days after surgery]
• Incidence of abdominal infection 7 days after surgery [Срок оценки: 7 days after surgery]
• Overall survival (OS) 3 years after surgery [Срок оценки: 3 years after surgery]
• Disease free survival (DFS) 3 years after surgery [Срок оценки: 3 years after surgery]

Критерии участия

Критерии включения

• 18 years old ≤ 80 years old;
• The primary tumor lesion is located in the upper part of the stomach or the esophagogastric junction (Siewert II or III), and it is expected that R0 surgical results can be obtained by performing proximal gastrectomy and D2 dissection；
• The primary lesion was diagnosed as adenocarcinoma through endoscopic biopsy and histopathological examination;
• If it is upper gastric adenocarcinoma, the clinical TNM staging based on imaging needs to be cT1N0M0. If it is ductal gastric junction adenocarcinoma, it needs to be cT1-3N0-1M0, and clinical imaging judgment shows no distant gastric lymph node metastasis；
• Expected survival exceeds 6 months;
• No history of upper abdominal surgery (excluding laparoscopic cholecystectomy);
• No chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc. were performed before surgery;
• Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1;
• Preoperative ASA (American Society of Anesthesiologists) grading I-III ;
• Good function of important organs;
• Sign the patient's informed consent form

Критерии исключения

• Preoperative imaging examination suggests the fusion of enlarged lymph nodes (maximum diameter ≥ 3cm) in the area;
• Pregnant and lactating women;
• Suffering from other malignant tumors within 5 years;
• Preoperative body temperature ≥ 38 ℃ or complicated with infectious diseases requiring systematic treatment;
• Serious mental illness;
• Severe respiratory diseases, FEV1<50% of the expected value;
• Severe liver and kidney dysfunction;
• History of unstable angina or heart attack within 6 months;
• History of cerebral infarction or cerebral hemorrhage within 6 months, excluding old intracavitary infarction;
• Apply systemic corticosteroid therapy within one month;
• Patients with complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery;
• The patient has participated or is currently participating in other clinical studies (within 6 months)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 3 центра

• Department of General Surgery, Ruijin Hospital, Shanghai Jiao Tong University School of Me — Шанхай
• Huashan Hospital, Fudan University — Шанхай
• Second Department of Gastric Surgery, Fudan University Shanghai Cancer Center, — Шанхай

Публикации

• Sakuramoto S, Yamashita K, Kikuchi S, Futawatari N, Katada N, Moriya H, Hirai K, Watanabe M. Clinical experience of laparoscopy-assisted proximal gastrectomy with Toupet-like partial fundoplication in early gastric cancer for preventing reflux esophagitis. J Am Coll Surg. 2009 Sep;209(3):344-51. doi: 10.1016/j.jamcollsurg.2009.04.011. Epub 2009 Jun 18. PMID 19717038
• Aizawa M, Yabusaki H, Nakada K, Matsuki A, Bamba T, Nakagawa S. A Retrospective Review of a Single-Center Experience with Posterolateral Fundoplication During Esophagogastrostomy After Proximal Gastrectomy. J Gastrointest Surg. 2021 Dec;25(12):3230-3233. doi: 10.1007/s11605-021-05052-8. Epub 2021 Jul 8. No abstract available. PMID 34240326
• Shoji Y, Nunobe S, Ida S, Kumagai K, Ohashi M, Sano T, Hiki N. Surgical outcomes and risk assessment for anastomotic complications after laparoscopic proximal gastrectomy with double-flap technique for upper-third gastric cancer. Gastric Cancer. 2019 Sep;22(5):1036-1043. doi: 10.1007/s10120-019-00940-0. Epub 2019 Mar 6. PMID 30838469
• Kuroda S, Choda Y, Otsuka S, Ueyama S, Tanaka N, Muraoka A, Hato S, Kimura T, Tanakaya K, Kikuchi S, Tanabe S, Noma K, Nishizaki M, Kagawa S, Shirakawa Y, Kamikawa Y, Fujiwara T. Multicenter retrospective study to evaluate the efficacy and safety of the double-flap technique as antireflux esophagogastrostomy after proximal gastrectomy (rD-FLAP Study). Ann Gastroenterol Surg. 2018 Oct 11;3(1):96-10 PMID 30697614
• Aihara R, Mochiki E, Ohno T, Yanai M, Toyomasu Y, Ogata K, Ando H, Asao T, Kuwano H. Laparoscopy-assisted proximal gastrectomy with gastric tube reconstruction for early gastric cancer. Surg Endosc. 2010 Sep;24(9):2343-8. doi: 10.1007/s00464-010-0947-8. Epub 2010 Apr 8. PMID 20376493
• Tanaka K, Ebihara Y, Kurashima Y, Nakanishi Y, Asano T, Noji T, Murakami S, Nakamura T, Tsuchikawa T, Okamura K, Shichinohe T, Hirano S. Laparoscopic proximal gastrectomy with oblique jejunogastrostomy. Langenbecks Arch Surg. 2017 Sep;402(6):995-1002. doi: 10.1007/s00423-017-1587-4. Epub 2017 May 10. PMID 28493146
• Aikou T, Natsugoe S, Shimazu H, Nishi M. Antrum preserving double tract method for reconstruction following proximal gastrectomy. Jpn J Surg. 1988 Jan;18(1):114-5. doi: 10.1007/BF02470857. PMID 3386066
• Zang L. [Reconstruction following laparoscopic gastrectomy for gastric cancer]. Zhonghua Wei Chang Wai Ke Za Zhi. 2012 Aug;15(8):787-9. Chinese. PMID 23072016

Идентификаторы

NCT: NCT06679244 · 2024-1173

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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