Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer

Официальное название

Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer: a Multi-center Randomized Controlled Trial

Обзор

Proximal early gastric cancer can choose radical total gastrectomy or proximal gastrectomy. But if use simple esophagogastric anastomosis for proximal gastrectomy, the incidence of postoperative reflux esophagitis is up to 62%, which seriously affects the quality of life, and the short-term outcome is poorer than the total gastrectomy. If the incidence of postoperative reflux esophagitis can be reduced, proximal gastrectomy would be the treatment choice for proximal early gastric cancer, which may more improve both quality of life and nutritional status than total gastrectomy. Double-flap technique is a new surgical procedure for the reconstruction between esophagus and remnant stomach, which was started to be applied to digestive tract reconstruction in patients with proximal early gastric cancer in 2016. It can reduce the occurrence of reflux oesophagitis. At present, the studies for double-flap technique in China and other countries are mostly retrospective studies, and there are short of large-scale prospective studies and evidence of evidence-based medicine. The applicant has initiated a phase II, single center, single arm study and the results suggested that the laparoscopic proximal gastrectomy with double-flap reconstruction technique was safe and effective for treating proximal early gastric cancer. To further validate the short and long-term outcomes of this procedure, a multicentre, open label, prospective, superiority and randomised controlled clinical trial was set up to compare laparoscopic proximal gastrectomy with double-flap technique with laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer. It include 216 patients with proximal early gastric cancer. The primary outcome is the proportion of patients who develop reflux esophagitis within 12 months after surgery. The short and long-term oncological outcomes are also explored. This trial can provide high-grade evidence of evidence-based medicine for double-flap technique's clinical applications .

Вмешательства

• Процедура Laparoscopic Proximal Gastrectomy With Double-flap Technique
  Patients in this group receive laparoscopic proximal gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9, 11p；D2 for stage IB: Nos.1, 2, 3a, 4 sa, 4 sb, 7, 8a, 9, 11p and 11d). The double-flap technique is used for the esophagogastric reconstruction.
• Процедура Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction
  Patients in this group receive laparoscopic total gastrectomy with D1+/D2 lymph node dissection(D1+ for stage IA：Nos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p；D2 for stage IB: Nos.1, 2, 3, 4, 5, 6, 7, 8a, 9, 11p and 11d, 12a). The Roux-en-Y esophagojejunostomy method is used for the esophagojejunal reconstruction.

Первичные конечные точки

• The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively [Срок оценки: 12 months postoperatively]

Вторичные конечные точки (12)

• Quality of Life after Surgery [Срок оценки: Follow-up evaluations are performed 3, 6 and 12 months postoperatively]
• Gastrointestinal Symptoms after Surgery [Срок оценки: Follow-up evaluations are performed 3, 6 and 12 months postoperatively]
• Changes in hemoglobin levels at Follow-up [Срок оценки: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Changes in Vitamin B12 levels at Follow-up [Срок оценки: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Changes in total protein levels at Follow-up [Срок оценки: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Changes in serum albumin levels at Follow-up [Срок оценки: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Changes in prealbumin levels at Follow-up [Срок оценки: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Late Postoperative Morbidity [Срок оценки: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.]
• Early Postoperative Morbidity [Срок оценки: From surgery to discharge, up to 30 days]
• Short-term Clinical Outcome After Surgery [Срок оценки: From surgery to discharge, up to 30 days]
• Short-term Clinical Outcome After Surgery [Срок оценки: From surgery to discharge, up to 30 days]
• Short-term Clinical Outcome After Surgery [Срок оценки: From surgery to discharge, up to 30 days]

Критерии участия

Критерии включения

• 20 years ≤ age ≤ 80 years
• The primary gastric lesions were located in the proximal third of the stomach
• histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
• clinical stage IA (T1N0M0) or IB (T1N1M0 / T2N0M0) according to the 8th edition of the American Joint Committee on Cancer(AJCC) staging system(Clinical stage was determined based on the finding of endoscopic ultrasonography and/or thoraco-abdominal contrast-enhanced computed tomography)
• scheduled for laparoscopic proximal gastrectomy with D1+/D2 lymphadenectomy or laparoscopic total gastrectomy with D1+/D2 lymphadenectomy , and possible for R0 surgery by this procedures (Lymphadenectomy is performed on the basis of the criteria of the Japanese Gastric Cancer Treatment Guidelines 2021 (6th edition).).
• The preoperative American Society of Anesthesiologists (ASA) physical status was I-III; The patient's cardiopulmonary function can tolerate laparoscopic surgery.
• The patients have signed the informed consent form.

Критерии исключения

• history of upper abdominal surgery (except laparoscopic cholecystectomy);
• the tumor invades the esophagus 3cm above gastro-esophageal junction (Z-line)
• with other malignant diseases or have suffered from other malignant diseases within 5 years
• require simultaneous surgery due to complicated with other diseases
• women are pregnant or in lactation period
• Suffering from serious mental illness
• history of continuous systemic corticosteroid or immunosuppressive drug treatment within 1 month

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 · 1 центр

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University — Гуанчжоу

Публикации

• Zhou S, Xie Y, Zhu Y, Tan J, Yang B, Zhong L, Zhong G, Han F. Comparing the antireflux effect of laparoscopic proximal gastrectomy with double-flap technique reconstruction versus laparoscopic total gastrectomy with Roux-en-Y reconstruction for proximal early gastric cancer: study protocol for a multicentre, prospective, open-label, randomised controlled trial. BMJ Open. 2024 Jul 4;14(7):e079940. PMID 38964794

Идентификаторы

NCT: NCT05890339 · SYSKY-2022-276-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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