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Comparison of Delta-Shaped and Billroth II After TLDG (TLDG)

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ClinicalTrials.gov Identifier: NCT02372747
Recruitment Status : Completed
First Posted : February 26, 2015
Last Update Posted : February 26, 2015
Sponsor:
Information provided by (Responsible Party):
Quan Wang, First Hospital of Jilin University

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

Condition or disease Intervention/treatment Phase
Gastric Cancer Procedure: Delta-shaped anastomosis Procedure: Billroth II anastomosis Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Comparison of Delta-Shaped and Billroth II for Intracorporeal Anastomosis After Totally Laparoscopic Distal Gastrectomy for Gastric Cancer
Study Start Date : October 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: Delta-shaped anastomosis group
The patients in DS group underwent Delta-shaped anastomosis after TLDG.
Procedure: Delta-shaped anastomosis
The patients in DS group underwent Delta-shaped anastomosis after TLDG.

Experimental: Billroth II anastomosis group
The patients in B-II group underwent Billroth-II anastomosis after TLDG.
Procedure: Billroth II anastomosis
The patients in B-II group underwent Billroth-II anastomosis after TLDG.




Primary Outcome Measures :
  1. Stage distribution [ Time Frame: up to 7 days after the operation ]
  2. Resected margin [ Time Frame: up to 7 days after the operation ]
  3. Operative time [ Time Frame: up to 7 days after the operation ]
  4. Anastomosis time [ Time Frame: up to 7 days after the operation ]
  5. The number of stapler cartridges used [ Time Frame: up to 7 days after the operation ]
  6. Median estimated blood loss [ Time Frame: up to 7 days after the operation ]
  7. Red blood cell transfusion [ Time Frame: up to 7 days after the operation ]
  8. Length of the incision [ Time Frame: up to 7 days after the operation ]

Secondary Outcome Measures :
  1. Postoperative complication [ Time Frame: up to 30 days after the operation ]
    Major complications includes anastomosis leakage and intrabdominal bleeding . Minor complications includes bile regurgitation,anastomotic stenosis and delayed gastric emptying.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02372747


Sponsors and Collaborators
First Hospital of Jilin University
Investigators
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Study Director: Quan Wang, Doctor First Hospital of Jilin University
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Responsible Party: Quan Wang, Deputy Director of General Surgery, First Hospital of Jilin University
ClinicalTrials.gov Identifier: NCT02372747    
Other Study ID Numbers: 2013-179
First Posted: February 26, 2015    Key Record Dates
Last Update Posted: February 26, 2015
Last Verified: February 2006
Keywords provided by Quan Wang, First Hospital of Jilin University:
Totally laparoscopic gastrectomy
laparoscopic distal gastrectomy
Intracorporeal anastomosis
Delta-Shaped Anastomosis
Billroth II Anastomosis
Gastric cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases