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Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

Primary Purpose

Stomach Neoplasms

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Isoperistaltic
Antiperistaltic
Sponsored by
Keimyung University Dongsan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stomach Neoplasms focused on measuring Gastric cancer, gastrojejunostomy, isoperistaltic, antiperistaltic

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keimyung University Dongsan Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Isoperistaltic

Antiperistaltic

Arm Description

Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach

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

Outcomes

Primary Outcome Measures

Dumping syndrome
Using Sigstad's score

Secondary Outcome Measures

long-term complication
all kind of complication
Total score of quality of life questionnaire
by EORTC questionnaire
Body weight change
for evaluate nutritional status
Surgical complication
all kind of complication within 1 month
Gastritis
by endoscopic evaluation

Full Information

First Posted
July 8, 2016
Last Updated
November 12, 2017
Sponsor
Keimyung University Dongsan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02837874
Brief Title
Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy
Official Title
Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy, Randomized Prospective Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 2016 (undefined)
Primary Completion Date
March 2019 (Anticipated)
Study Completion Date
March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keimyung University Dongsan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasms
Keywords
Gastric cancer, gastrojejunostomy, isoperistaltic, antiperistaltic

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isoperistaltic
Arm Type
Active Comparator
Arm Description
Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach
Arm Title
Antiperistaltic
Arm Type
Experimental
Arm Description
Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach
Intervention Type
Procedure
Intervention Name(s)
Isoperistaltic
Intervention Description
Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach
Intervention Type
Procedure
Intervention Name(s)
Antiperistaltic
Intervention Description
Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach
Primary Outcome Measure Information:
Title
Dumping syndrome
Description
Using Sigstad's score
Time Frame
12 months
Secondary Outcome Measure Information:
Title
long-term complication
Description
all kind of complication
Time Frame
from 1 month to 12 months
Title
Total score of quality of life questionnaire
Description
by EORTC questionnaire
Time Frame
12 months
Title
Body weight change
Description
for evaluate nutritional status
Time Frame
12 months
Title
Surgical complication
Description
all kind of complication within 1 month
Time Frame
within 1 month
Title
Gastritis
Description
by endoscopic evaluation
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seung Wan Ryu, M.D., Ph.D.
Phone
82-53-250-7322
Email
gsman@dsmc.or.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seung Wan Ryu, M.D., Ph.D.
Organizational Affiliation
Keimyung University Dongsan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keimyung University Dongsan Medical Center
City
Daegu
ZIP/Postal Code
700-712
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seung Wan Ryu, MD, PhD
Phone
82-53-250-7322
Email
gsman@dsmc.or.kr
First Name & Middle Initial & Last Name & Degree
In Gyu Kwon, MD
Phone
82-53-250-7322
Email
surgeon@dsmc.or.kr
First Name & Middle Initial & Last Name & Degree
Seung Wan Ryu, MD, PhD
First Name & Middle Initial & Last Name & Degree
In Gyu Kwon, MD
First Name & Middle Initial & Last Name & Degree
Young Gil Son, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
23233009
Citation
Banerjee A, Ding Y, Mikami DJ, Needleman BJ. The role of dumping syndrome in weight loss after gastric bypass surgery. Surg Endosc. 2013 May;27(5):1573-8. doi: 10.1007/s00464-012-2629-1. Epub 2012 Dec 12.
Results Reference
result
PubMed Identifier
12496544
Citation
Bergamaschi R, Arnaud JP, Marvik R, Myrvold HE. Laparoscopic antiperistaltic versus isoperistaltic gastrojejunostomy for palliation of gastric outlet obstruction in advanced cancer. Surg Laparosc Endosc Percutan Tech. 2002 Dec;12(6):393-7. doi: 10.1097/00129689-200212000-00002.
Results Reference
result
PubMed Identifier
20829078
Citation
Mine S, Sano T, Tsutsumi K, Murakami Y, Ehara K, Saka M, Hara K, Fukagawa T, Udagawa H, Katai H. Large-scale investigation into dumping syndrome after gastrectomy for gastric cancer. J Am Coll Surg. 2010 Nov;211(5):628-36. doi: 10.1016/j.jamcollsurg.2010.07.003. Epub 2010 Sep 15.
Results Reference
result
PubMed Identifier
8763175
Citation
Houghton AD, Liepins P, Clarke S, Mason R. Iso- or antiperistaltic anastomosis: does it matter? J R Coll Surg Edinb. 1996 Jun;41(3):148-51.
Results Reference
result

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Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

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