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

Stomach Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05890339
• Other study ID #: SYSKY-2022-276-02
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 10, 2023
• Est. completion date: May 10, 2033

Study information

• Verified date: September 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Han Fanhai, Professor
• Phone: +86-135-8031-7677
• Email: fh_han[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: May 10, 2033
• Est. primary completion date: December 10, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (16)

Lead Sponsor

Collaborator

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

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 Tumor Hospital & Institute, Qilu Hospital of Shandong University, Qinghai Province Cancer Hospital, Shandong Provincial Hospital Affiliated to Shandong First Medical University, 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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life after Surgery	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.	Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Secondary	Gastrointestinal Symptoms after Surgery	gastrointestinal symptoms are assessed by Gastrointestinal Quality of Life Index (GIQLI) questionnaires. Higher scores mean a better outcome.	Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Secondary	Changes in hemoglobin levels at Follow-up	blood hemoglobin(g/L) levels	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Changes in Vitamin B12 levels at Follow-up	blood Vitamin B12(µg/ml) levels	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Changes in total protein levels at Follow-up	blood total protein(g/L) levels	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Changes in serum albumin levels at Follow-up	blood serum albumin(g/L) levels	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Changes in prealbumin levels at Follow-up	blood prealbumin(g/L) levels	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Late Postoperative Morbidity	adhesive ileus, anastomosis stenosis, malnutrition, dumping syndrome. All postoperative complications are classified according to the Clavien-Dindo(CD) classification standard.	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Early Postoperative Morbidity	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.	From surgery to discharge, up to 30 days
Secondary	Short-term Clinical Outcome After Surgery	time to pass gas(hours)	From surgery to discharge, up to 30 days
Secondary	Short-term Clinical Outcome After Surgery	time to oral intake(hours)	From surgery to discharge, up to 30 days
Secondary	Short-term Clinical Outcome After Surgery	time to indwell gastric tube(hours)	From surgery to discharge, up to 30 days
Secondary	Short-term Clinical Outcome After Surgery	length of postoperative hospitalisation(days)	From surgery to discharge, up to 30 days
Secondary	Surgical Characteristics	operative time(minutes)	24 hours postoperatively
Secondary	Surgical Characteristics	time for reconstruction the digestive tract(minutes) during surgery	24 hours postoperatively
Secondary	Surgical Characteristics	blood loss(ml) during surgery	24 hours postoperatively
Secondary	3-year disease-free survival rate	3-year disease-free survival rate	3 years
Secondary	3-year overall survival rate	3-year overall survival rate	3 years
Secondary	3-year recurrence pattern	3-year recurrence pattern	3 years
Secondary	5-year disease-free survival rate	5-year disease-free survival rate	5 years
Secondary	5-year overall survival rate	5-year overall survival rate	5 years
Secondary	5-year recurrence pattern	5-year recurrence pattern	5 years
Secondary	body mass index postoperatively	body mass index(kg/m^2)	Follow-up evaluations are performed 3, 6 and 12 months postoperatively.
Secondary	Quality of Life 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.	Follow-up evaluations are performed 3, 6 and 12 months postoperatively
Secondary	Postoperative pain assessment	We measured the pain score using visual analog scale(VAS) at 24 hours after the surgery is completed. Higher scores mean a worse outcome.	Day 1 postoperatively
Secondary	Pathological Characteristics	lymph nodes dissection extent for each patient in the surgery	1 week postoperatively
Secondary	Pathological Characteristics	number of dissected lymph nodes for each patient in the surgery	1 week postoperatively
Secondary	Pathological Characteristics	R0 resection rate. R0 resection represents complete resection of the tumor, meaning there is no residual tumor.	1 week postoperatively
Secondary	Proportion of participants die after surgery	mortality rate	From surgery to discharge, up to 30 days
Secondary	Proportion of participants need to rehospitalized after surgery	rehospitalization rate.	From surgery to discharge, up to 30 days