NCT05450835

Brief Summary

Abstract Background Our previous studies have shown OGT method significantly simplified overlap esophagojejunostomy with good short-term outcomes, and provided new perspectives for optimizing esophagojejunostomy. However, the safety and efficiency of OGT method still need evidence of randomized controlled trial. Methods: This trial is a prospective, multicenter, randomized, controlled, open, and superiority trial. Three hundred and forty-four patients who met the inclusion criteria and did not accord with the exclusion criteria will be randomly divided into OGT group(n=172) and traditional group(n=172). The primary purpose of this study is to evaluate time of oesophagojejunostomy of OGT method compared with traditional method for Siewert III/II esophagogastric junction cancer and gastric cancer. The second purpose is to evaluate the success rate of inserting anvil fork into esophageal lumen at first attempt, attempts of inserting anvil fork into esophagus, early postoperative complications,recovery course and compare the postoperative hospital stay of the patients enrolled in this study. Discussion: This trial is the first prospective randomized two-arm controlled study to determine the safety and efficiency of OGT method compared with traditional overlap method. Through this trial, we hope to show that experienced surgeons can safely perform OGT-assisted overlap esophagojejunostomy for Siewert III/II esophagogastric junction cancer and gastric cancer.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
344

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
Completed

Started Sep 2022

Typical duration for not_applicable gastric-cancer

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 11, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 26, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

2.7 years

First QC Date

July 1, 2022

Last Update Submit

May 26, 2025

Conditions

Gastric Cancer

Keywords

Gastric/gastroesophageal junction (G/GEJ) tumorsLaparoscopy total gastrectomyOverlap esophagojejunostomyOGT

Outcome Measures

Primary Outcomes (1)

  • Time of oesophagojejunostomy

    Time starts from making the entry hole for the anastomosis on the oesophagealstump, to the end of the common entry hole was closed using barbed threads.

    1 Days

Study Arms (2)

Arm A

EXPERIMENTAL

In OGT group,After the enterotomy was made, the nasogastric tube was pulled out 3 cm from the oesophagal lumen to connect with the OGT. Next, the anvil fork sleeved with OGT insert into the oesophageal mucosa canal by movement of the connection of fork -OGT -gastric tube. Then, the anaesthesiologist continued to pull back the nasogastric tube for 10 cm to ensure that the stapler would not clamp the nasogastric tube. After that, the surgeon began to fire the stapler to perform side-to-side esophagojejunostomy.

Procedure: OGT group

Arm B

ACTIVE COMPARATOR

In overlap group, the oesophagojejunostomy was performed as reported by Inaba et al. After firing the stapler, two openings were converted into a single entry hole to create an end-to-side oesophagojejunostomy, and the entry hole was closed with full-thickness running suture using barbed sutures intracorporeally.

Procedure: Overlap group

Interventions

OGT groupPROCEDURE

In OGT group,the nasogastric tube was pulled out 3 cm from the oesophagal lumen to connect with the OGT. Meanwhile, the OGT was sleeved on anvil fork extracorporeally and the linear stapler was put into abdomen through trocar on the right side and then cartridge fork was inserted through jejunum opening towards the oral side of the lumen. Next, the anvil fork sleeved with OGT insert into the oesophageal mucosa canal by movement of the connection of fork -OGT -gastric tube.

Arm A
Overlap groupPROCEDURE

In overlap group, the oesophagojejunostomy was performed as reported by Inaba et al.

Arm B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18-75 years;
  • Primary lesion is pathologically diagnosed as gastric adenocarcinoma;
  • Expected to live more than 1 year;
  • Tumor located located in gastroesophageal junction (GEJ) involve esophagus no more than 2cm, or in the upper, upper to middle, or entire stomach, and intend to perform laparoscopic total gastrectomy with D2 lymphadenectomy
  • No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
  • Preoperative performance status (ECOG, Eastern Cooperative Oncology Group) of 0 or 1;
  • Preoperative ASA (American Society of Anesthesiologists) scoring: I-III;
  • Without preoperative radiotherapy;
  • Did not found metastasis preoperatively and intraoperatively;
  • Sufficient organ functions;
  • Written informed consent.

You may not qualify if:

  • Women during pregnancy or breast-feeding;
  • Body temperature ≥ 38 °C before surgery or infectious disease with a systemic therapy indicated;
  • Severe mental disease;
  • Confirmed stage IV (AJCC 8th) during surgery
  • Severe respiratory disease;
  • Severe hepatic and renal dysfunction;
  • Unstable angina pectoris or history of myocardial infarction within 6 months;
  • History of cerebral infarction or cerebral hemorrhage within 6 months;
  • Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery;
  • Performing hyperthermic intraperitoneal chemotherapy (HIPEC) after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Fujian Medical University 2nd Affiliated Hoapital

Quanzhou, Fujian, China

RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, 510515, China

COMPLETED

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

RECRUITING

Sixth affiliated hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

COMPLETED

The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

Guangzhou, Guangdong, China

RECRUITING

The First Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

RECRUITING

Ganzhou City People Hospital

Ganzhou, Guangxi, China

RECRUITING

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

COMPLETED

The First Affiliated Hospital of Nanhua University

Hengyang, Hunan, 421001, China

COMPLETED

The First Hospital Of Jilin University

Changchun, Jilin, China

COMPLETED

The First Hospital of China Medical University

Shenyang, Liaoning, 110001, China

COMPLETED

The People's Hospital of Changzhi

Changzhi, Shanxi, China

COMPLETED

MeSH Terms

Conditions

Stomach NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Jiang Yu, Ph.D

    Nanfang Hospital, Southern Medical University

    PRINCIPAL INVESTIGATOR

  • Quan Wang, Ph.D

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

  • Kai Ye, Ph.D

    Fujian Medical University 2nd Affiliated Hoapital

    PRINCIPAL INVESTIGATOR

  • Chuanfa Fang, Ph.D

    Ganzhou City People Hospital

    PRINCIPAL INVESTIGATOR

  • Feirang Zhang, Ph.D

    First Affiliated Hospital of Shantou University Medical College

    PRINCIPAL INVESTIGATOR

  • Wei Wang, Ph.D

    The First Affiliated Hospital, Guangzhou University of Traditional Chinese Medicine

    PRINCIPAL INVESTIGATOR

  • Wenqing Hu, Ph.D

    The People's Hospital of Changzhi

    PRINCIPAL INVESTIGATOR

  • Junjiang Wang, Ph.D

    Guangdong Provincial People's Hospital

    PRINCIPAL INVESTIGATOR

  • Lei Lian, Ph.D

    Sixth affiliated hospital of Sun Yat-sen University

    PRINCIPAL INVESTIGATOR

  • Jiaquan Zhu, Ph.D

    First Hospital of China Medical University

    PRINCIPAL INVESTIGATOR

  • Yi Zhang, Ph.D

    The Third Xiangya Hospital of Central South University

    PRINCIPAL INVESTIGATOR

  • Shuai Xiao, Ph.D

    The First Affiliated Hospital of Nanhua University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Xinhua Chen, Ph.D

CONTACT

+8615626452302xinhuachen03@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: In OGT group,the oesophagojejunostomy was performed with OGT-assisted overlap method. In overlap group, the oesophagojejunostomy was performed as reported by Inaba et al.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2022

First Posted

July 11, 2022

Study Start

September 1, 2022

Primary Completion

May 26, 2025

Study Completion

December 30, 2025

Last Updated

May 31, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The IPD will be available for the investigation.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
August, 2022-August, 2025
Access Criteria
All the accession for research will be admitted.

Locations

CN(12)