Safety and Efficacy of OGT Method Versus the Traditional Overlap Method

NCT ID: NCT05442502

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 155 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-01
• Study Completion Date: 2022-03-01

Brief Summary

Introduction: The safety and efficiency of OGT-assisted method have not yet been compared with conventional overlap approach.

Methods Retrospectively analyses the data of 155 gastric/gastroesophageal junction (G/GEJ) cancer patients who underwent laparoscopic total gastrectomy by conventional(conventional group, n=83) or OGT-assisted (OGT group, n=72) overlap methods at Nanfang Hospital. The anastomotic efficiency and surgical outcomes were compared between two groups.

Detailed Description

Although our previous multicenter randomized controlled trial (CLASS-01) has confirmed the safety and efficacy of laparoscopic distal gastrectomy for gastric cancer[1, 2], the feasibility of laparoscopic total gastrectomy (LTG) remains uncertain. The most challenging technical difficulty of LTG is esophagojejunostomy(ESJ)[3, 4]. At present, there is still no consensus on the ideal anastomosis method for EJ.

Since overlap esophagojejunostomy was first proposed in 2010[5], it has gradually gone mainstream because of its lower incidence of anastomotic-related complications and satisfactory short-term outcomes[6-10]. However, the overlap approach is technically-difficult and time-consuming, and might confront intraoperative construction complications, such as injuring esophagus caused by the repetition of inserting anvil fork into esophagus or developing esophageal submucosa pseudocanals(video 1 and 2). Therefore, we first designed an overlap guiding tube (OGT)-assisted method to overcame above limitations[11]. And the first reported about the application of OGT-assisted method preliminarily indicated that it is safe and feasible, with a satisfactory success rate of inserting anvil fork into esophageal lumen at first attempt and esophagojejunostomy time[11]. However, the safety and efficiency of OGT-assisted method have not yet been compared side-by-side with the conventional overlap approach. Therefore, this study aimed to compare the OGT-assisted and conventional overlap methods in terms of feasibility and safety in LTG for gastric/gastroesophageal junction (G/GEJ) tumors.

Methods Patients One hundred and fifty-five patients with G/GEJ cancer undergoing LTG via either the conventional overlap esophagojejunostomy(conventional group) or OGT-assisted overlap esophagojejunostomy (OGT group) in the Department of Gastrointestinal Surgery, Southern Medical University Nanfang Hospital, between June 2018 and February 2022 were initially eligible for the study. The inclusion criteria were as follows: (1)gastric cancer was confirmed by pathological examination; (2) tumor located in GEJ with involving esophagus no more than 2cm or the upper, upper to the middle, or entire stomach; (3) had no obvious operative contraindication; and (4) aged 18-85 years. The pathological staging was based on the TNM system of the 8th edition of the International Federation for the prevention and treatment of cancer[12]. This study meets the requirements of the Helsinki Declaration revised in 2013. Patients and their families signed informed consent forms before operation. This study followed the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) reporting guideline. The data collection protocol was approved by the Ethics Committee of Nanfang Hospital, Southern Medical University. Written informed consent was obtained from all the patients in the study.

Conditions

Gastric Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

The conventional overlap group

In conventional overlap group, after firing the stapler, two openings were converted into a single entry hole to create an end-to-side esophagojejunostomy, and the entry hole was closed with full-thickness running suture using barbed sutures intracorporeally.

The conventional overlap method

Intervention Type: PROCEDURE

After firing the stapler, two openings were converted into a single entry hole to create an end-to-side esophagojejunostomy, and the entry hole was closed with full-thickness running suture using barbed sutures intracorporeally.

The OGT-assisted group

In OGT group, the anvil fork was inserted into the esophageal mucosa canal by movement of the connection of fork-OGT-gastric tube.

The overlap guiding tube(OGT) method

Intervention Type: PROCEDURE

The overlap guiding tube(OGT) is used to assist the anvil fork placed into the esophageal cavity.

Interventions

The overlap guiding tube(OGT) method

The overlap guiding tube(OGT) is used to assist the anvil fork placed into the esophageal cavity.

Intervention Type: PROCEDURE

The conventional overlap method

After firing the stapler, two openings were converted into a single entry hole to create an end-to-side esophagojejunostomy, and the entry hole was closed with full-thickness running suture using barbed sutures intracorporeally.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• (1)gastric cancer was confirmed by pathological examination; (2) tumor located in GEJ with involving esophagus no more than 2cm or the upper, upper to the middle, or entire stomach; (3) had no obvious operative contraindication; and (4) aged 18-85 years.

Exclusion Criteria

• Null.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jiang Yu, Prof.

Role: PRINCIPAL_INVESTIGATOR

Nanfang Hospital, Southern Medical University

Locations

Nanfang Hospital

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

NFEC-202204-K17-01

Identifier Type: -

Identifier Source: org_study_id