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

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
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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
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Procedure: Antiperistaltic
Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach |
- Dumping syndrome [ Time Frame: 12 months ]Using Sigstad's score
- 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

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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 |
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

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
Contact: Seung Wan Ryu, M.D., Ph.D. | 82-53-250-7322 | gsman@dsmc.or.kr |
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 |
Principal Investigator: | Seung Wan Ryu, M.D., Ph.D. | Keimyung University Dongsan Medical Center |
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 |
Gastric cancer gastrojejunostomy isoperistaltic antiperistaltic |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Stomach Diseases Antidiarrheals Gastrointestinal Agents |