Clinical trial NCT05890339: Laparoscopic Proximal Gastrectomy With Double-flap Technique Versus Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction for Proximal Early Gastric Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stomach Neoplasms
Keywords: laparoscopy
minimally invasive surgical procedures
stomach neoplasm
Gastrectomy
Reflux Esophagitis
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: First Hospital of China Medical University
name: Tianjin Medical University Cancer Institute and Hospital
name: Liaoning Cancer Hospital & Institute
name: Sichuan Provincial People's Hospital
name: Third Affiliated Hospital, Sun Yat-Sen University
name: Qilu Hospital of Shandong University
name: First Affiliated Hospital of Kunming Medical University
name: First Affiliated Hospital of Guangxi Medical University
name: Zunyi Medical College
name: Sichuan Cancer Hospital and Research Institute
name: Gansu Provincial Hospital
name: Shandong Provincial Hospital
name: The First Affiliated Hospital of Zhengzhou University
name: Qinghai Province Cancer Hospital
name: LanZhou University
First posted: 2023-06-06
Enrollment: 216
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 .


Eligibility criteria: Inclusion Criteria:

1. 20 years ≤ age ≤ 80 years
2. The primary gastric lesions were located in the proximal third of the stomach
3. histologically proven gastric adenocarcinoma (by preoperative gastrofiberscopy)
4. 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)
5. 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).).
6. The preoperative American Society of Anesthesiologists (ASA) physical status was I-III; The patient's cardiopulmonary function can tolerate laparoscopic surgery.
7. The patients have signed the informed consent form.

Exclusion Criteria:

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

Primary outcomes:
measure: The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively
timeFrame: 12 months postoperatively
Secondary outcomes:
measure: Quality of Life after Surgery
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
measure: Gastrointestinal Symptoms after Surgery
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
measure: Changes in hemoglobin levels at Follow-up
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Changes in Vitamin B12 levels at Follow-up
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Changes in total protein levels at Follow-up
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Changes in serum albumin levels at Follow-up
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Changes in prealbumin levels at Follow-up
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Late Postoperative Morbidity
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Early Postoperative Morbidity
timeFrame: From surgery to discharge, up to 30 days
measure: Short-term Clinical Outcome After Surgery
timeFrame: From surgery to discharge, up to 30 days
measure: Short-term Clinical Outcome After Surgery
timeFrame: From surgery to discharge, up to 30 days
measure: Short-term Clinical Outcome After Surgery
timeFrame: From surgery to discharge, up to 30 days
measure: Short-term Clinical Outcome After Surgery
timeFrame: From surgery to discharge, up to 30 days
measure: Surgical Characteristics
timeFrame: 24 hours postoperatively
measure: Surgical Characteristics
timeFrame: 24 hours postoperatively
measure: Surgical Characteristics
timeFrame: 24 hours postoperatively
measure: 3-year disease-free survival rate
timeFrame: 3 years
measure: 3-year overall survival rate
timeFrame: 3 years
measure: 3-year recurrence pattern
timeFrame: 3 years
measure: 5-year disease-free survival rate
timeFrame: 5 years
measure: 5-year overall survival rate
timeFrame: 5 years
measure: 5-year recurrence pattern
timeFrame: 5 years
measure: body mass index postoperatively
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
measure: Quality of Life postoperatively
timeFrame: Follow-up evaluations are performed 3, 6 and 12 months postoperatively
measure: Postoperative pain assessment
timeFrame: Day 1 postoperatively
measure: Pathological Characteristics
timeFrame: 1 week postoperatively
measure: Pathological Characteristics
timeFrame: 1 week postoperatively
measure: Pathological Characteristics
timeFrame: 1 week postoperatively
measure: Proportion of participants die after surgery
timeFrame: From surgery to discharge, up to 30 days
measure: Proportion of participants need to rehospitalized after surgery
timeFrame: From surgery to discharge, up to 30 days
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
state: Guangdong
Study officials:
References: