NCT05826106

Brief Summary

This study proposes a novel, straightforward, and viable technique for performing posterior gastrojejunostomy anastomosis during totally laparoscopic Billroth-II reconstruction with Braun anastomosis (named R anastomosis). This study prospectively evaluated clinical and pathological data from patients who underwent totally laparoscopic distal gastrectomy with R anastomosis at Northern Jiangsu People's Hospital, China, in order to investigate the feasibility and functional outcomes of R anastomosis for B-II-B anastomosis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
Last Updated

April 24, 2023

Status Verified

April 1, 2023

Enrollment Period

3.5 years

First QC Date

April 11, 2023

Last Update Submit

April 11, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Complication

    Anastomotic leakage;Anastomotic site bleeding;Anastomotic stenosis;Gastric emptying dysfunction

    6 months

Study Arms (1)

R anastomosis

Procedure: R anastomosis

Interventions

R anastomosisPROCEDURE

Modifying the surgical technique of totally laparoscopic Billroth-II reconstruction with Braun anastomosis and to name it as the R anastomosis.

R anastomosis

Eligibility Criteria

Age35 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All cases were confirmed to have malignant tumors in the gastric antrum or body through endoscopic and pathological examinations, and multi-slice spiral CT scans revealed no distant metastasis.

You may qualify if:

  • (1) Elective surgery, indications for surgery: Cases diagnosed with malignant tumors of the gastric antrum or body by endoscopy and pathology, confirmed by multi-slice spiral CT to have no distant metastasis. (2) Patients who underwent laparoscopic distal gastrectomy with Billroth II + Braun anastomosis for gastric cancer, and can be followed up after surgery.

You may not qualify if:

  • (1) Patients who received neoadjuvant chemotherapy before surgery; (2) Emergency surgery patients; (3) Patients with concurrent malignant tumors; (4) Patients lost to follow-up due to non-tumor reasons after surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northern Jiangsu People's Hospital

Yangzhou, Jiangsu, 225001, China

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DR

Study Record Dates

First Submitted

April 11, 2023

First Posted

April 24, 2023

Study Start

March 1, 2019

Primary Completion

September 1, 2022

Study Completion

March 1, 2023

Last Updated

April 24, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations