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Clinical Trial of Reconstruction After Proximal Gastrectomy

Primary Purpose

Esophagitis, Reflux

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

left-opening single-flap technique

double-flap group technique

About this trial

This is an interventional treatment trial for Esophagitis, Reflux focused on measuring left open single-flap technique, proximal gastrectomy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria

Patients aged 18-80 years, regardless of gender;
Siewert III of the esophagogastric junction adenocarcinoma: Stage Ⅰ(cT1-2N0M0) or adenocarcinoma of the upper part of the stomach： Stage Ⅰ(cT1-2N0M0), Stage II( cT1-2N1-3M0 / cT3-4N0M0), Stage III(cT3-4aN1-3M0); patients who are suitable for surgery according to the 8th AJCC clinical staging of gastric cancer;
Primary lesion diagnosed by preoperative endoscopic end pathology: tumor diameter <4 cm and located in the upper part of the stomach (including the esophagogastric junction), histologically confirmed adenocarcinoma;
Preoperative ASA score: I, II, or III;
Preoperative Karnofsky physical status score: ≥ 70%; or preoperative ECOG physical status score: ≤ 2;
No distant metastases (confirmed by preoperative chest X-ray, abdominal ultrasound, and upper abdominal CT); no peritoneal implant metastases (confirmed by laparoscopic exploration surgery);
R0 surgical outcome is expected to be obtained with radical gastrectomy of D2 proximal gastric cancer;
Patients and their families voluntarily participate in this study and sign the informed consent form after understanding the study content.

Exclusion Criteria

Patients received any preoperative treatment, such as chemotherapy, radiotherapy, targeted therapy or immunotherapy; preoperative neoadjuvant chemotherapy recipients;
Patients with clinical stage exceeding Siewert III of the esophagogastric junction adenocarcinoma: Stage Ⅰ(cT1-2N0M0) or more than adenocarcinoma of the upper part of the stomach: Stage Ⅰ(cT1-2N0M0), Stage II(cT1-2N1-3M0/cT3-4N0M0), Stage III(cT3-4aN1-3M0);
Patients with acute infections, especially biliary tract infections;
Patients with complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery;
Patients with uncorrectable coagulation dysfunction;
Patients with vital organ failure, such as heart, lung, liver, brain, kidney, etc.
Severe central nervous system disease, mental disorders, or impaired consciousness;
Pregnant or lactating women;
Patients with distant metastases;
Patients with a primary tumor at another site diagnosed within the past 5 years;
Preoperative ASA score: ≥ IV;
Preoperative ECOG physical status score: ≥ 2;
History of continuous systemic corticosteroid therapy within the past 1 month;
History of unstable angina, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months;
Patients with concurrent surgical treatment of other diseases;
Patients with immunodeficiency, immunosuppression, or autoimmune diseases (organ transplant requiring immunosuppressive therapy within the past 5 years, allogeneic bone marrow transplant patients, taking immunosuppressive drugs, etc.);
Patients with concurrent participation in other clinical studies;
Patients refusing to sign an informed consent form to participate in this study;
Preoperative imaging: regional fusion of enlarged lymph nodes (maximal diameter > 3 cm).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

the trial group (left-opening single-flap group)

the control group (double-flap group)

Arm Description

left-opening single-flap group

double-flap group

Outcomes

Primary Outcome Measures

Incidence of reflux esophagitis

Secondary Outcome Measures

Overall postoperative complication rate

Incidence of anastomotic fistula

Operation time

Bleeding loss volume

incidence of anastomotic stricture

Incidence of reflux esophagitis

Full Information

NCT ID

NCT05418920

First Posted

June 6, 2022

Last Updated

June 30, 2022

Sponsor

Oncogastroenterology Committee of Chinese

Collaborators

Tang-Du Hospital, First Affiliated Hospital Xi'an Jiaotong University, General Hospital of Ningxia Medical University, Henan Provincial People's Hospital, The First Affiliated Hospital of Shanxi Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05418920

Brief Title

Clinical Trial of Reconstruction After Proximal Gastrectomy

Official Title

Comparing the Efficacy of Double-flap Technique Versus Single-flap Technique After Proximal Gastrectomy: a Multicentre Randomized Controlled Trial

Study Type

Interventional

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

August 1, 2022 (Anticipated)

Primary Completion Date

July 31, 2024 (Anticipated)

Study Completion Date

July 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Oncogastroenterology Committee of Chinese

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

1) To explore a simple, safe, post-proximal gastrectomy reconstruction method with good absorption and digestive function in order to improve patients' postoperative quality of life; 2) To fill the gap in the comparison of clinical efficacy between left-open single-flap technique and double-flap technique in this specialized field in China; 3) To utilize the experience and foundation of gastrointestinal surgery in the treatment of gastric cancer and integrate the advantageous resources in China; 4) To establish a large-sample, multicenter randomized clinical study in order to promote the establishment and improvement of relevant norms of gastrointestinal reconstruction

Detailed Description

Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths each year. Although the incidence of gastric cancer has decreased worldwide compared to the past, the incidence of esophagogastric junction cancer and upper 1/3 gastric cancer is gradually increasing. Currently, the main treatment for esophagogastric junction cancer and upper gastric cancer is surgery. However, there is no clinical consensus on the choice of surgical approach for these patients. Compared with total gastrectomy, proximal gastrectomy can preserve the physiological function of the stomach and has great advantages in nutrient absorption, thus it has been widely accepted in Asian countries. However, the risk of developing reflux esophagitis after proximal gastrectomy is high, which seriously affects patients' postoperative quality of life. In order to reduce the occurrence of postoperative complications, clinicians continue to improve the methods of GI reconstruction. Currently, the common methods of GI reconstruction after proximal gastrectomy include esophagogastrostomy (EG), jejunal intubation (JI), jejunal pouch intubation (JPI), and dual-tract reconstruction (DTR). However, the choice of the optimal reconstruction method after proximal gastrectomy remains controversial, and there is no standard approach to GI reconstruction. In 2016, Kuroda et al. reported a new surgical approach with a double-flap technique after proximal gastrectomy and showed satisfactory short-term outcomes compared with conventional esophagogastric anastomosis. At the 1-year postoperative follow-up, no reflux esophagitis was detected in all patients. At the same time, the rate of anastomotic stenosis was noteworthy. This study will be the first attempt at a left-open single-flap technique, which was modified from the double-flap technique. The short-term outcome was satisfactory in all patients. This study will establish a large sample, multicenter randomized clinical study. By exploring a simple, safe, good absorption and digestive function method of post-proximal gastrectomy reconstruction to improve patients' postoperative quality of life and fill the gap in the comparison of clinical efficacy between left-open single-flap technique and double-flap technique in this specialized field. This will promote the establishment and improvement of the specifications related to gastrointestinal reconstruction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Esophagitis, Reflux

Keywords

left open single-flap technique, proximal gastrectomy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

the trial group (left-opening single-flap group)

Arm Type

Experimental

Arm Description

left-opening single-flap group

Arm Title

the control group (double-flap group)

Arm Type

Active Comparator

Arm Description

double-flap group

Intervention Type

Procedure

Intervention Name(s)

left-opening single-flap technique

Intervention Description

left-opening single-flap technique

Intervention Type

Procedure

Intervention Name(s)

double-flap group technique

Intervention Description

double-flap group technique

Primary Outcome Measure Information:

Title

Incidence of reflux esophagitis

Description

Incidence of reflux esophagitis

Time Frame

12 months

Secondary Outcome Measure Information:

Title

Overall postoperative complication rate

Description

Overall postoperative complication rate

Time Frame

30 days

Title

Incidence of anastomotic fistula

Description

Incidence of anastomotic fistula

Time Frame

30 days

Title

Operation time

Description

Operation time

Time Frame

intraoperative

Title

Bleeding loss volume

Description

Bleeding loss volume

Time Frame

intraoperative

Title

incidence of anastomotic stricture

Description

incidence of anastomotic stricture

Time Frame

30 days

Title

Incidence of reflux esophagitis

Description

Incidence of reflux esophagitis

Time Frame

6 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria Patients aged 18-80 years, regardless of gender; Siewert III of the esophagogastric junction adenocarcinoma: Stage Ⅰ(cT1-2N0M0) or adenocarcinoma of the upper part of the stomach： Stage Ⅰ(cT1-2N0M0), Stage II( cT1-2N1-3M0 / cT3-4N0M0), Stage III(cT3-4aN1-3M0); patients who are suitable for surgery according to the 8th AJCC clinical staging of gastric cancer; Primary lesion diagnosed by preoperative endoscopic end pathology: tumor diameter <4 cm and located in the upper part of the stomach (including the esophagogastric junction), histologically confirmed adenocarcinoma; Preoperative ASA score: I, II, or III; Preoperative Karnofsky physical status score: ≥ 70%; or preoperative ECOG physical status score: ≤ 2; No distant metastases (confirmed by preoperative chest X-ray, abdominal ultrasound, and upper abdominal CT); no peritoneal implant metastases (confirmed by laparoscopic exploration surgery); R0 surgical outcome is expected to be obtained with radical gastrectomy of D2 proximal gastric cancer; Patients and their families voluntarily participate in this study and sign the informed consent form after understanding the study content. Exclusion Criteria Patients received any preoperative treatment, such as chemotherapy, radiotherapy, targeted therapy or immunotherapy; preoperative neoadjuvant chemotherapy recipients; Patients with clinical stage exceeding Siewert III of the esophagogastric junction adenocarcinoma: Stage Ⅰ(cT1-2N0M0) or more than adenocarcinoma of the upper part of the stomach: Stage Ⅰ(cT1-2N0M0), Stage II(cT1-2N1-3M0/cT3-4N0M0), Stage III(cT3-4aN1-3M0); Patients with acute infections, especially biliary tract infections; Patients with complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery; Patients with uncorrectable coagulation dysfunction; Patients with vital organ failure, such as heart, lung, liver, brain, kidney, etc. Severe central nervous system disease, mental disorders, or impaired consciousness; Pregnant or lactating women; Patients with distant metastases; Patients with a primary tumor at another site diagnosed within the past 5 years; Preoperative ASA score: ≥ IV; Preoperative ECOG physical status score: ≥ 2; History of continuous systemic corticosteroid therapy within the past 1 month; History of unstable angina, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months; Patients with concurrent surgical treatment of other diseases; Patients with immunodeficiency, immunosuppression, or autoimmune diseases (organ transplant requiring immunosuppressive therapy within the past 5 years, allogeneic bone marrow transplant patients, taking immunosuppressive drugs, etc.); Patients with concurrent participation in other clinical studies; Patients refusing to sign an informed consent form to participate in this study; Preoperative imaging: regional fusion of enlarged lymph nodes (maximal diameter > 3 cm).

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaohua Li, MD

Phone

+8613474299901

xjyylixiaohua@163.com

First Name & Middle Initial & Last Name or Official Title & Degree

Gang Ji, MD

Phone

+8613572152581

xijingweichang@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nan Wang, MD

Organizational Affiliation

Tang-Du Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Chao Zhang, MD

Organizational Affiliation

Henan Provincial People's Hospital

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Lei Wang, MD

Organizational Affiliation

General Hospital of Ningxia Medical University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Renwei Chang, MD

Organizational Affiliation

The First Affiliated Hospital of Shanxi Medical University

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Junjun She, MD

Organizational Affiliation

First Affiliated Hospital Xi'an Jiaotong University

Official's Role

Study Chair

12. IPD Sharing Statement

Learn more about this trial

Clinical Trial of Reconstruction After Proximal Gastrectomy

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