Clinical Trial of Reconstruction After Proximal Gastrectomy

NCT05418920 | Not Yet Recruiting

• 1 other identifier: single-flap technique
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

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

Conditions

Esophagitis, Reflux

Keywords

left open single-flap technique, proximal gastrectomy

Outcome Measures

Primary Outcomes (1)

• Incidence of reflux esophagitis

  Incidence of reflux esophagitis

  12 months

Secondary Outcomes (6)

• Overall postoperative complication rate

  30 days

• Incidence of anastomotic fistula

  30 days

• Operation time

  intraoperative

• Bleeding loss volume

  intraoperative

• incidence of anastomotic stricture

  30 days

Study Arms (2)

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

EXPERIMENTAL

left-opening single-flap group

Procedure: left-opening single-flap technique

the control group (double-flap group)

ACTIVE COMPARATOR

double-flap group

Procedure: double-flap group technique

Interventions

left-opening single-flap technique PROCEDURE

left-opening single-flap technique

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

double-flap group technique PROCEDURE

double-flap group technique

the control group (double-flap group)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Oncogastroenterology Committee of Chinese: lead
• Tang-Du Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• General Hospital of Ningxia Medical University: collaborator
• Henan Provincial People's Hospital: collaborator
• The First Affiliated Hospital of Shanxi Medical University: collaborator

Related Publications (1)

• Yang QC, Wang WD, Mo ZC, Yue C, Zhou HK, Gao RQ, Yu J, Dong DH, Liu JQ, Wei JP, Yang XS, Ji G, Li XH. Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial. Front Oncol. 2022 Nov 17;12:973810. doi: 10.3389/fonc.2022.973810. eCollection 2022.

  PMID: 36465382 DERIVED

MeSH Terms

Conditions

Esophagitis, Peptic

Condition Hierarchy (Ancestors)

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

Study Officials

• Nan Wang, MD

  Tang-Du Hospital

  STUDY CHAIR

• Chao Zhang, MD

  Henan Provincial People's Hospital

  STUDY CHAIR

• Lei Wang, MD

  General Hospital of Ningxia Medical University

  STUDY CHAIR

• Renwei Chang, MD

  The First Affiliated Hospital of Shanxi Medical University

  STUDY CHAIR

• Junjun She, MD

  First Affiliated Hospital Xi'an Jiaotong University

  STUDY CHAIR

Central Study Contacts

Xiaohua Li, MD

CONTACT

+8613474299901; xjyylixiaohua@163.com

Gang Ji, MD

CONTACT

+8613572152581; xijingweichang@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: June 6, 2022
• First Posted: June 14, 2022
• Study Start: August 1, 2022
• Primary Completion: July 31, 2024
• Study Completion (Estimated): July 31, 2027
• Last Updated: July 5, 2022

Record last verified: 2022-06