Comparison of Delta-Shaped and Billroth II After TLDG

Gastric Cancer Clinical Trial

— TLDG  

Official title:

Comparison of Delta-Shaped and Billroth II for Intracorporeal Anastomosis After Totally Laparoscopic Distal Gastrectomy for Gastric Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02372747
• Other study ID #: 2013-179
• Status: Completed
• Phase: N/A
• First received: January 22, 2015
• Last updated: February 21, 2015
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: February 2006
• Source: First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

To compare the safety and feasibility of Delta-shaped anastomosis and Billroth II anastomosis after totally laparoscopic distal gastrectomy for gastric cancer(TLDG).

Description:

Methods: 78 consecutive patients who underwent TLDG in First Hospital of Jilin University between October 2012 and December 2014 were enrolled in this study . All patients were divided randomly into two groups:Delta-shaped anastomosis group (DS group) and Billroth II anastomosis group (B-II group), and the patients in DS group underwent Delta-shaped anastomosis after TLDG, and the patients in B-II group underwent Billroth-II anastomosis after TLDG.Outcome measures,resected margin,operative time,anastomosis time,number of stapler cartridges used,length of the incision,the time of first flatus and liquid diet,hospital stay and postoperative morbidity are compared between the two groups.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: December 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• carcinoma located in the lower 1/3 of gastric body or antrum of stomach

• diagnosed by endoscopy ,endoscopic ultrasonography and abdominal CT scan

• diameter of the tumor <3cm

• no pyloric obstruction

Exclusion Criteria:

• diameter of the tumor =3cm

• associated with obstruction, bleeding, emergency surgery or surgical intervention

• tumor with extensive metastasis

• patient had previously undergone gastrostomy

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Procedure:
• Delta-shaped anastomosis
The patients in DS group underwent Delta-shaped anastomosis after TLDG.
• Billroth II anastomosis
The patients in B-II group underwent Billroth-II anastomosis after TLDG.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
First Hospital of Jilin University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stage distribution		up to 7 days after the operation	No
Primary	Resected margin		up to 7 days after the operation	No
Primary	Operative time		up to 7 days after the operation	No
Primary	Anastomosis time		up to 7 days after the operation	No
Primary	The number of stapler cartridges used		up to 7 days after the operation	No
Primary	Median estimated blood loss		up to 7 days after the operation	No
Primary	Red blood cell transfusion		up to 7 days after the operation	No
Primary	Length of the incision		up to 7 days after the operation	No
Secondary	Postoperative complication	Major complications includes anastomosis leakage and intrabdominal bleeding . Minor complications includes bile regurgitation,anastomotic stenosis and delayed gastric emptying.	up to 30 days after the operation	No