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NCT Number: NCT05890339

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

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 .

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Key information

Conditions

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

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Guangzhou, Guangdong, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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 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.

Primary outcomes

  1. The Proportion of Patients With Reflux Esophagitis Within 12 Months Postoperatively

    Time frame: 12 months postoperatively

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

Secondary outcomes

  1. Quality of Life after Surgery

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

    Quality of life(QoL) is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) 30-item core QoL (QLQ-C30 ver.3.0). Higher scores mean a worse outcome.

  2. Gastrointestinal Symptoms after Surgery

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

    gastrointestinal symptoms are assessed by Gastrointestinal Quality of Life Index (GIQLI) questionnaires. Higher scores mean a better outcome.

  3. Changes in hemoglobin levels at Follow-up

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

    blood hemoglobin(g/L) levels

  4. Changes in Vitamin B12 levels at Follow-up

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

    blood Vitamin B12（μg/ml) levels

  5. Changes in total protein levels at Follow-up

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

    blood total protein(g/L) levels

  6. Changes in serum albumin levels at Follow-up

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

    blood serum albumin(g/L) levels

  7. Changes in prealbumin levels at Follow-up

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

    blood prealbumin(g/L) levels

  8. Late Postoperative Morbidity

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

    adhesive ileus, anastomosis stenosis, malnutrition, dumping syndrome. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard.

  9. Early Postoperative Morbidity

    Time frame: From surgery to discharge, up to 30 days

    operation wound with seroma, hematoma, infection, dehiscence, or evisceration, anastomotic leakage, anastomotic bleeding, abdominal bleeding, abdominal abscess, intestinal obstruction morbidity, gastrointestinal bleeding, gastroparesis, postoperative pancreatitis, pancreatic fistula, chylous leakage, lung morbidity, cerebrovascular morbidity, cardiovascular morbidity, deep vein thrombosis, cholecystitis, liver dysfunction, kidney dysfunction. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard.

  10. Short-term Clinical Outcome After Surgery

    Time frame: From surgery to discharge, up to 30 days

    time to pass gas(hours)

  11. Short-term Clinical Outcome After Surgery

    Time frame: From surgery to discharge, up to 30 days

    time to oral intake(hours)

  12. Short-term Clinical Outcome After Surgery

    Time frame: From surgery to discharge, up to 30 days

    time to indwell gastric tube(hours)

  13. Short-term Clinical Outcome After Surgery

    Time frame: From surgery to discharge, up to 30 days

    length of postoperative hospitalisation(days)

  14. Surgical Characteristics

    Time frame: 24 hours postoperatively

    operative time(minutes)

  15. Surgical Characteristics

    Time frame: 24 hours postoperatively

    time for reconstruction the digestive tract(minutes) during surgery

  16. Surgical Characteristics

    Time frame: 24 hours postoperatively

    blood loss(ml) during surgery

  17. 3-year disease-free survival rate

    Time frame: 3 years

    3-year disease-free survival rate

  18. 3-year overall survival rate

    Time frame: 3 years

    3-year overall survival rate

  19. 3-year recurrence pattern

    Time frame: 3 years

    3-year recurrence pattern

  20. 5-year disease-free survival rate

    Time frame: 5 years

    5-year disease-free survival rate

  21. 5-year overall survival rate

    Time frame: 5 years

    5-year overall survival rate

  22. 5-year recurrence pattern

    Time frame: 5 years

    5-year recurrence pattern

  23. body mass index postoperatively

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

    body mass index(kg/m^2)

  24. Quality of Life postoperatively

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

    Quality of life(QoL) is evaluated using the European Organization for Research and Treatment of Cancer (EORTC) gastric cancer module (QLQ-STO22) questionnaire. Higher scores mean a worse outcome.

  25. Postoperative pain assessment

    Time frame: Day 1 postoperatively

    We measured the pain score using visual analog scale(VAS) at 24 hours after the surgery is completed. Higher scores mean a worse outcome.

  26. Pathological Characteristics

    Time frame: 1 week postoperatively

    lymph nodes dissection extent for each patient in the surgery

  27. Pathological Characteristics

    Time frame: 1 week postoperatively

    number of dissected lymph nodes for each patient in the surgery

  28. Pathological Characteristics

    Time frame: 1 week postoperatively

    R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor.

  29. Proportion of participants die after surgery

    Time frame: From surgery to discharge, up to 30 days

    mortality rate

  30. Proportion of participants need to rehospitalized after surgery

    Time frame: From surgery to discharge, up to 30 days

    rehospitalization rate.

Study contacts

Contact information is provided by the study sponsor or research team.

Han Fanhai, Professor

CONTACT

[email protected]

+86-135-8031-7677

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2029
Study completion
2033
First posted
Jun 6, 2023
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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