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

NCT05890339 | Not Yet Recruiting

• 1 other identifier: SYSKY-2022-276-02
• Study Type: interventional
• Target: 216
• Locations: 1 country
• Sites: 1

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 .

Conditions

Stomach Neoplasms

Keywords

laparoscopy; minimally invasive surgical procedures; stomach neoplasm; Gastrectomy; Reflux Esophagitis

Outcome Measures

Primary Outcomes (1)

• The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively

  During follow-up endoscopy 1 year after surgery, reflux esophagitis are graded according to the Los Angeles (LA) classification.

  12 months postoperatively

Secondary Outcomes (30)

• Quality of Life after Surgery

  Follow-up evaluations are performed 3, 6 and 12 months postoperatively

• Gastrointestinal Symptoms after Surgery

  Follow-up evaluations are performed 3, 6 and 12 months postoperatively

• Changes in hemoglobin levels at Follow-up

  Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

• Changes in Vitamin B12 levels at Follow-up

  Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

• Changes in total protein levels at Follow-up

  Follow-up evaluations are performed 3, 6 and 12 months postoperatively.

Study Arms (2)

Laparoscopic Proximal Gastrectomy With Double-flap Technique

EXPERIMENTAL

Procedure: Laparoscopic Proximal Gastrectomy With Double-flap Technique

Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction

ACTIVE COMPARATOR

Procedure: Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction

Interventions

Laparoscopic Proximal Gastrectomy With Double-flap Technique PROCEDURE

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.

Laparoscopic Proximal Gastrectomy With Double-flap Technique

Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction PROCEDURE

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.

Laparoscopic Total Gastrectomy With Roux-en-Y Reconstruction

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead
• First Hospital of China Medical University: collaborator
• Tianjin Medical University Cancer Institute and Hospital: collaborator
• Liaoning Cancer Hospital & Institute: collaborator
• Sichuan Provincial People's Hospital: collaborator
• Third Affiliated Hospital, Sun Yat-Sen University: collaborator
• Qilu Hospital of Shandong University: collaborator
• First Affiliated Hospital of Kunming Medical University: collaborator
• First Affiliated Hospital of Guangxi Medical University: collaborator
• Zunyi Medical College: collaborator
• Sichuan Cancer Hospital and Research Institute: collaborator
• Gansu Provincial Hospital: collaborator
• Shandong Provincial Hospital: collaborator
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Qinghai Province Cancer Hospital: collaborator
• LanZhou University: collaborator

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Location

Related Publications (1)

• 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. doi: 10.1136/bmjopen-2023-079940.

  PMID: 38964794 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Esophagitis; Esophageal Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases

Central Study Contacts

Han Fanhai, Professor

CONTACT

+86-135-8031-7677; fh_han@163.com

Study Design

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

Study Record Dates

• First Submitted: May 3, 2023
• First Posted: June 6, 2023
• Study Start: June 10, 2023
• Primary Completion (Estimated): December 10, 2029
• Study Completion (Estimated): May 10, 2033
• Last Updated: June 6, 2023

Record last verified: 2022-09

Locations

CN (1)