Prospective Study on Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery for Distal Gastric Cancer

Stomach Neoplasms Clinical Trial

— MDSG  

Official title:

Prospective Randomized Controlled Trial on Clinical Application Value of Modified Delta-shaped Gastroduodenostomy in Totally Laparoscopic Surgery and Billroth-I Anastomosis in Laparoscopy-assisted Surgery for Distal Gastric Cancer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02289183
• Other study ID #: 2015-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: December 2023

Study information

• Verified date: February 2020
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to explore the clinical application value of modified delta-shaped gastroduodenostomy in totally laparoscopic surgery for distal gastric cancer.

Description:

A prospective randomized comparison of the modified delta-shaped gastroduodenostomy in totally laparoscopic surgery and Billroth-I anastomosis in laparoscopy-assisted surgery for distal gastric cancer will be performed, to evaluate the clinical value and provide theoretical basis and clinical experience for the extensive application of the modified technique. The evaluation parameters are perioperative clinical efficacy, postoperative life quality, immune function and 3-year survival and recurrence rates.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 240
• Est. completion date: December 2023
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Age from 18 to 75 years (including 18 and 75 years old)

• Primary distal gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy

• cT1-4a, N0-3, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition

• Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy

• Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)

• American Society of Anesthesiology score (ASA) class I, II, or III

• Written informed consent

Exclusion Criteria:

• Women during pregnancy or breast-feeding

• Severe mental disorder

• History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

• History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection

• Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging

• History of other malignant disease within past five years

• History of previous neoadjuvant chemotherapy or radiotherapy

• History of unstable angina or myocardial infarction within past six months

• History of cerebrovascular accident within past six months

• History of continuous systematic administration of corticosteroids within one month

• Requirement of simultaneous surgery for other disease

• Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

• FEV1<50% of predicted values

Related Conditions & MeSH terms

• Stomach Neoplasms

Intervention

Procedure:
• Totally laparoscopic distal gastrectomy
Totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy
• Laparoscopy-assisted distal gastrectomy
Laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3-year disease free survival rate		36 months
Secondary	Morbidity and mortality	The early postoperative complication and mortality are defined as the event observed within 30 days after surgery, while the time frame for late complication is the period from postoperative day 31th to the end of month 36th.	30 days;36 months
Secondary	Intraoperative situation	Operation time, intraoperative blood loss and transfusion volume, conversive rate, intraoperative bleeding and viscera damage, and incision length are used to access the intraoperative situation	1 day
Secondary	Postoperative recovery course	Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.	10 days
Secondary	Postoperative nutritional status and quality of life	The variation of weight, cholesterol and albumin on postoperative 3, 6, 9 and 12 months, and the results of endoscopy on postoperative 3 and 12 months are used to access the postoperative nutritional status and quality of life.	12 months
Secondary	Inflammatory and immune response	The daily highest body temperature before discharge and the values of white blood cell count, hemoglobin, C-reactive protein, prealbumin and relevant immune cytokines including T cell percentage, T-helper lymphocytes (CD4+) percentage, T-suppressor lymphocytes (CD8+) percentage, natural killer (NK) cells percentage from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded.	7 days
Secondary	3-year overall survival rate		36 months
Secondary	3-year recurrence pattern	Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.	36 months