Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy, Randomized Prospective Pilot Study

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.

Study Overview

• Status: Unknown
• Conditions: Stomach Neoplasms
• Intervention / Treatment: Procedure: Isoperistaltic; Procedure: Antiperistaltic

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Daegu, Korea, Republic of, 700-712
    • Recruiting
    • Keimyung University Dongsan Medical Center
    • Contact: Seung Wan Ryu, MD, PhD; Phone Number: 82-53-250-7322; Email: gsman@dsmc.or.kr
    • Contact: In Gyu Kwon, MD; Phone Number: 82-53-250-7322; Email: surgeon@dsmc.or.kr
    • Principal Investigator: Seung Wan Ryu, MD, PhD
    • Sub-Investigator: In Gyu Kwon, MD
    • Sub-Investigator: Young Gil Son, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dumping syndrome	Using Sigstad's score	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Keimyung University Dongsan Medical Center
• Investigators: Principal Investigator: Seung Wan Ryu, M.D., Ph.D., Keimyung University Dongsan Medical Center

Publications and helpful links

General Publications

• 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, 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): March 1, 2019
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: July 8, 2016
• First Submitted That Met QC Criteria: July 15, 2016
• First Posted (Estimate): July 20, 2016

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 12, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: Gastric cancer; gastrojejunostomy; isoperistaltic; antiperistaltic
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms; Gastrointestinal Agents; Antidiarrheals
• Other Study ID Numbers: 2016-02-052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes