Clinical trial NCT02644148: Uncut Roux-en-Y Gastrojejunostomy for Early Gastric Cancer Patients
Official title: The Effect of Uncut Roux-en-Y Gastrojejunostomy on Quality of Life After Laparoscopic Distal Gastrectomy for Early Gastric Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Gastric Cancer
Lead sponsor: The First Affiliated Hospital with Nanjing Medical University
Sponsor class: OTHER
First posted: 2015-12-31
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our centre. Our previous results showed that this operation had a low postoperative complication and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe procedure. However, some limitations are noticed. The report from South Korea is a retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to improve QOL of patients after laparoscopic distal gastrectomy.

Detailed description: The current commonly used for distal gastri cancer in gastrointestinal anastomosis is Roux-en-Y. However, the complications after Roux-en-Y reach an incidence of over 30% which involve nausea, vomiting, and abdominal distension. The underlying mechanism might be the result of interruption of intestine peristalsis. In 2013, Kim reported total laparoscopic uncut Roux-en-Y anastomosis could reduce Roux stasis syndrome incidence by keeping the continuity of jejunum. In September 2014, we carried out this operation in 30 cases in our centre. Our previous results showed that this operation had a low postoperative complication and short hospitalization time, indicating uncut Roux-en-Y anastomosis might be a safe procedure. However, some limitations are noticed. The report from South Korea is a retrospective study and the evaluation of QOL is certain subjective. Here, we aimed to perform the first randomized controlled clinical study on uncut Roux-en-Y anastomosis to improve QOL of patients after laparoscopic distal gastrectomy. The primary aim is to determine whether uncut Roux-en-Y anastomosis improve the quality of life of patients after laparoscopic distal gastrectomy.

Eligibility criteria: Inclusion Criteria:

* Endoscopy and biopsy confirmed gastric antrum or angle (from the cardia more than 4cm) of gastric cancer
* tumor stage: I
* There is no experience with chemotherapy, no distant metastasis
* Have their own ability to answer the questionnaire
* There is no mental illness
* Age between 18-70 years old
* Agreed to participate in the experiment and signed informed consent

Exclusion Criteria:

* pregnant or nursing patients
* The combined more serious cardiovascular disease, liver and kidney dysfunction (glutamic-pyruvic transaminase/glutamic oxalacetic transaminase more than three times the upper limit of normal, serum creatinine more than 50% higher than the upper limit of normal), abnormal blood clotting function (mean prothrombin time, activated partial thromboplastin time higher than normal values above the upper limit of 50%), neuropsychiatric disorders
* Patients with active infection
* Have other malignant tumor
* Some reason withdraw subjects, can not enrolled in the study again

Primary outcomes:
measure: Quality of life
timeFrame: one year
Secondary outcomes:
measure: Complications
timeFrame: one year
Other outcomes:
Locations:
city: Nanjing
country: China
facility: the First Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Zekuan Xu, Professor
role: PRINCIPAL_INVESTIGATOR
References: