Uncut Roux-en-Y Gastrojejunostomy for Early Gastric Cancer Patients

NCT ID: NCT02644148

Last Updated: 2016-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2019-02-28

Brief Summary

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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

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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.

Conditions

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Gastric Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Conventional Roux-en-Y anastomosis

Conventional Roux-en-Y Gastrojejunostomy will be used after laparoscopic distal gastrectomy for early gastric cancer.

Group Type OTHER

Conventional Roux-en-Y Gastrojejunostomy

Intervention Type PROCEDURE

Conventional Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients

Uncut Roux-en-Y anastomosis

Uncut Roux-en-Y Gastrojejunostomy will be used after laparoscopic distal gastrectomy for early gastric cancer.

Group Type EXPERIMENTAL

Uncut Roux-en-Y Gastrojejunostomy

Intervention Type PROCEDURE

Uncut Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients

Interventions

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Conventional Roux-en-Y Gastrojejunostomy

Conventional Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients

Intervention Type PROCEDURE

Uncut Roux-en-Y Gastrojejunostomy

Uncut Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Zekuan Xu

Director of the Department of General Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zekuan Xu, Professor

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Locations

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the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hao Xu, Doctor

Role: CONTACT

0086 13851530117

Facility Contacts

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Hao Xu, Doc.

Role: primary

0086 13851530117

References

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Cai Z, Mu M, Ma Q, Liu C, Jiang Z, Liu B, Ji G, Zhang B. Uncut Roux-en-Y reconstruction after distal gastrectomy for gastric cancer. Cochrane Database Syst Rev. 2024 Feb 29;2(2):CD015014. doi: 10.1002/14651858.CD015014.pub2.

Reference Type DERIVED
PMID: 38421211 (View on PubMed)

Xu H, Yang L, Zhang DC, Li Z, Li QY, Wang LJ, Li FY, Wang WZ, Xia YW, Xu ZK. To cut or not to cut? A prospective randomized controlled trial on short-term outcomes of the uncut Roux-en-Y reconstruction for gastric cancer. Surg Endosc. 2023 Aug;37(8):6172-6184. doi: 10.1007/s00464-023-10067-0. Epub 2023 May 9.

Reference Type DERIVED
PMID: 37160808 (View on PubMed)

Other Identifiers

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JSPH-0504

Identifier Type: -

Identifier Source: org_study_id

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