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

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.

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.

Study Design

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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

Genetic and Rare Diseases Information Center resources: Stomach Cancer

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

Dumping syndrome [ Time Frame: 12 months ]
Using Sigstad's score

Secondary Outcome Measures :

long-term complication [ Time Frame: from 1 month to 12 months ]
all kind of complication
Total score of quality of life questionnaire [ Time Frame: 12 months ]
by EORTC questionnaire
Body weight change [ Time Frame: 12 months ]
for evaluate nutritional status
Surgical complication [ Time Frame: within 1 month ]
all kind of complication within 1 month
Gastritis [ Time Frame: 12 months ]
by endoscopic evaluation

Eligibility Criteria

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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

Contacts and Locations

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

More Information

Publications of Results:

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.

Bergamaschi R, Arnaud JP, Mårvik 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.

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.

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.

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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

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