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Comparisons Between Isoperistaltic and Antiperistaltic Gastrojejunostomy in Laparoscopic Distal Gastrectomy

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02837874
Enrollment
80
Registered
2016-07-20
Start date
2016-03-31
Completion date
2019-03-31
Last updated
2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

Keywords

Gastric cancer, gastrojejunostomy, isoperistaltic, antiperistaltic

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.

Interventions

PROCEDUREIsoperistaltic

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

PROCEDUREAntiperistaltic

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

Sponsors

Keimyung University Dongsan Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Dumping syndrome12 monthsUsing Sigstad's score

Secondary

MeasureTime frameDescription
long-term complicationfrom 1 month to 12 monthsall kind of complication
Total score of quality of life questionnaire12 monthsby EORTC questionnaire
Body weight change12 monthsfor evaluate nutritional status
Surgical complicationwithin 1 monthall kind of complication within 1 month
Gastritis12 monthsby endoscopic evaluation

Countries

South Korea

Contacts

Primary ContactSeung Wan Ryu, M.D., Ph.D.
gsman@dsmc.or.kr82-53-250-7322

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026