Double Tract Anastomosis and Gastric Tube Anastomosis to Proximal Gastrectomy

NCT02288728 | Terminated DMC

• 1 other identifier: WCH-GC-01
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric cancer as one of the most common gastrointestinal cancers, radical resection of primary lesions combined with dissection of regional lymph-nodes is acknowledged by surgeons all over the world. When compared with the advanced upper third gastric cancer, proximal gastrectomy has been acknowledged as the standard therapeutic strategy for the early gastric cancer located in the upper third of the stomach. However, due to abandon the anti-reflux barrier of the digestive system caused by the dissection of the cardia and the lower esophageal sphincter, the belching、hiccup、Acid reflux、heartburn、chest pain symptoms and as well as the reflux esophagitis caused by the traditional esophagostomy permanently influence the postoperative quality of life for those patients. Nowadays, relationship between the digestive track reconstruction for proximal gastrectomy and the postoperative quality of life is still with controversies. Previous study reported the gastric tube anastomosis can minimize the reflux related symptoms when compared with traditional esophagogastrostomy. There still exited some patients need long-term anti-acid drug to control the reflux symptoms although underwent the gastric tube anastomosis. The double-track anastomosis for proximal gastrectomy may successfully control the reflux symptoms and there existed study found it is as safe as the esophagostomy. But there has no randomized control study to compare the postoperative quality of life between the gastric tube anastomosis and double-track anastomosis for proximal gastrectomy. By the reasons above, a randomized controlled trial is conducted with the intention to compare the intraoperative and postoperative mortality and morbidity and the postoperative quality of life between the esophagogastrostomy and the double-track anastomosis in the proximal gastrectomy for gastric cancer patients.

Conditions

Complications; Quality of Life; Remnant Gastritis; Reflux Esophagitis

Keywords

Proximal gastrectomy; quality of life; mortality; morbidity

Outcome Measures

Primary Outcomes (1)

• postoperative mortality and morbidity

  postoperative period (30 days)

Secondary Outcomes (4)

• Intraoperative mortality and morbidity

  Intraoperative

• postoperative quality of life

  Postoperative period (at least one year)

• remnant gastritis

  postoperative period (one year)

• reflux esophagitis

  Postoperative period (one year)

Study Arms (2)

Group B (double-track anastomosis)

EXPERIMENTAL

Patients in the Group B will received the double-track anastomosis with proximal gastrectomy.

Procedure: Double-track anastomosis

Group A (Gastric tube anastomosis)

OTHER

Patients in the Group A (Gastric tube anastomosis) will take the gastric tube anastomosis with proximal gastrectomy.

Procedure: Gastric tube anastomosis

Interventions

Gastric tube anastomosis PROCEDURE

In the gastric tube group, the lesser curvature of the gastric remnant approximately 3 cm proximal to the pylorus was removed first by a linear stapling device. An approximately 5-cm-wide tubular stomach was then constructed with preserved right gastric vessels. The length of the tube was consistent with the greater curvature of the residual stomach. The reconstructed gastric tube was lastly anastomosed with the proximal esophageal end. (Reference: Chen XF, Zhang B, Chen ZX, Hu JK, Dai B, Wang F, Yang HX, Chen JP. Gastric tube reconstruction reduces postoperative gastroesophageal reflux in adenocarcinoma of esophagogastric junction. Dig Dis Sci. 2012;57(3):738-745.)

Group A (Gastric tube anastomosis)

Double-track anastomosis PROCEDURE

Double-track anastomosis group: First, cut off the jejunum about 15-20 cm away from the Treitz ligament; Second, Roux-en-Y esophagojejunostomy (E-J stomy, first anastomosis) was perform by 25mm circular stapler device; Third, from 30-40cm to the E-J stomy, perform the side-to-side gastrojejunostomy (G-J stomy, second anastomosis). Forth, from 25-30cm to the G-J stomy, perform the jejunojejunostomy (J-J stomy, third anastomosis). (Reference: Ahn SH, Jung do H, Son SY, Lee CM, Park do J, Kim HH. Laparoscopic double-tract proximal gastrectomy for proximal early gastric cancer. Gastric Cancer. 2014;17(3):562-70.)

Group B (double-track anastomosis)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Preoperative endoscopy and biopsy confirmed upper third gastric adenocarcinoma, and predictively feasible of proximal gastrectomy ;
• Predictively resectable diseases, early gastric cancer, of preoperative staging JGCA 14th Edition cT1N0M0-T2N0M0;
• Age：≤75 years, or ≥18 years;
• Without serious disease and malignance disease;
• Patients without previous history of upper abdominal surgery;
• WHO performance score ≤2, ASA score ≤3;
• No limit to sexual and race;
• informed consent required.

You may not qualify if:

• With the history of the malignance disease;
• Patients with other severe complications cannot tolerate surgery: such as severe heart and lung diseases, heart function below clinical stage 2, uncontrollable hypertension, pulmonary infection, moderate to severe COPD, chronic bronchitis, severe diabetes and / or renal insufficiency, severe hepatitis and / or function below the rank of CHILD B grade, and severe malnutrition, etc.
• Patients treated with neoadjuvant chemotherapy or radiation therapy which might affect the efficacy observation;
• Severity mental diseases;
• After signature the Clinical trial agreement, patients and their agent will quit the trial;
• primary lesion cannot be resected in the pattern of transabdominal proximal gastrectomy, but for total gastrectomy, Whipple's procedure, or combined organ resection or with a transthoracic approach surgery
• After signature the Clinical trial agreement, patients and their agent will quit the trial.

Sponsors & Collaborators

• Jian-Kun Hu: lead

Study Sites (1)

West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China

Location

MeSH Terms

Conditions

Esophagitis, Peptic

Condition Hierarchy (Ancestors)

Esophagitis; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Gastroenteritis; Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice director of the Gastrointestinal Surgery Derpartment

Study Record Dates

• First Submitted: September 29, 2014
• First Posted: November 11, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: December 11, 2017

Record last verified: 2017-12

Locations

CN (1)