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Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

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ClinicalTrials.gov Identifier: NCT02837874
Recruitment Status : Unknown
Verified November 2017 by Seung Wan Ryu, Keimyung University Dongsan Medical Center.
Recruitment status was:  Recruiting
First Posted : July 20, 2016
Last Update Posted : November 14, 2017
Sponsor:
Information provided by (Responsible Party):
Seung Wan Ryu, Keimyung University Dongsan Medical Center

Brief Summary:
Billroth-II (gastrojejunostomy) is one of major option after gastrectomy for gastric cancer. The investigators hypothesized that isoperistaltic anastomosis lead to higher incidence of dumping syndrome but antiperistaltic (anisoperistaltic) anastomosis have relevance to gastric stasis or obstruction. The investigators will assess complications, dumping syndrome and quality of life between isoperistaltic and antiperistaltic after distal gastrectomy for gastric cancer.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Procedure: Isoperistaltic Procedure: Antiperistaltic Not Applicable

Detailed Description:
Recently, laparoscopic approach has been a option for gastric cancer, especially early gastric cancer. There are growing interest in quality of life in addition to recurrence or survival. There are few report about peristalsis and no report for quality of life according to a direction of peristalsis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy, Randomized Prospective Pilot Study
Study Start Date : March 2016
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Active Comparator: Isoperistaltic
Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach
Procedure: Isoperistaltic
Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach

Experimental: Antiperistaltic
Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach
Procedure: Antiperistaltic
Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach




Primary Outcome Measures :
  1. Dumping syndrome [ Time Frame: 12 months ]
    Using Sigstad's score


Secondary Outcome Measures :
  1. long-term complication [ Time Frame: from 1 month to 12 months ]
    all kind of complication

  2. Total score of quality of life questionnaire [ Time Frame: 12 months ]
    by EORTC questionnaire

  3. Body weight change [ Time Frame: 12 months ]
    for evaluate nutritional status

  4. Surgical complication [ Time Frame: within 1 month ]
    all kind of complication within 1 month

  5. Gastritis [ Time Frame: 12 months ]
    by endoscopic evaluation



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically confirmed adenocarcinoma in stomach
  • Scheduled as laparoscopic distal gastrectomy (tumor located lower or middle third)
  • Planned with gastrojejunostomy after gastrectomy
  • Clinical stage T1N0M0 or T2N0M0
  • ECOG 0 or 1 (The Eastern Cooperative Oncology Group)
  • ASA score class I-III (The American Society of Anesthesiologists)
  • patient has given their written informed consent to participate in the study

Exclusion Criteria:

  • Simultaneously combined resection of other organ (including cholecystectomy)
  • Active other malignancy
  • Requiring total gastrectomy
  • Chronic inflammatory bowel disease or other chronic disease related to bowel motility
  • Uncontrolled diabetes or patients with diabetic complications
  • Vulnerable patients

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): NCT02837874


Contacts
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Contact: Seung Wan Ryu, M.D., Ph.D. 82-53-250-7322 gsman@dsmc.or.kr

Locations
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Korea, Republic of
Keimyung University Dongsan Medical Center Recruiting
Daegu, Korea, Republic of, 700-712
Contact: Seung Wan Ryu, MD, PhD    82-53-250-7322    gsman@dsmc.or.kr   
Contact: In Gyu Kwon, MD    82-53-250-7322    surgeon@dsmc.or.kr   
Principal Investigator: Seung Wan Ryu, MD, PhD         
Sub-Investigator: In Gyu Kwon, MD         
Sub-Investigator: Young Gil Son, MD, PhD         
Sponsors and Collaborators
Keimyung University Dongsan Medical Center
Investigators
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Principal Investigator: Seung Wan Ryu, M.D., Ph.D. Keimyung University Dongsan Medical Center
Publications of Results:
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Responsible Party: Seung Wan Ryu, Director of Gastrointesinal surgery, professor, Keimyung University Dongsan Medical Center
ClinicalTrials.gov Identifier: NCT02837874    
Other Study ID Numbers: 2016-02-052
First Posted: July 20, 2016    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Seung Wan Ryu, Keimyung University Dongsan Medical Center:
Gastric cancer
gastrojejunostomy
isoperistaltic
antiperistaltic
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
Antidiarrheals
Gastrointestinal Agents