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Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy

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ClinicalTrials.gov Identifier: NCT03613142
Recruitment Status : Not yet recruiting
First Posted : August 2, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Biao Fan, MD, Beijing Cancer Hospital

Brief Summary:
The patients with upper gastric cancer (cT1N0M0) or gastroesophageal adenocarcinoma (diameter less than 4 cm) will be enrolled into this study. Each of these patients will undergo radical proximal gastrectomy and be randomly allocated into one of the two groups, double tract anastomosis group or esophagogastrostomy group. The following data will be collected to compare the difference between the two reconstruction methods: the rate of reflux esophagitis, postoperative quality of life, economic expenditure, the safety of operation, postoperative recovery, postoperative nutrition status and oncological effect. Through the comprehensive analysis, the result of this study will elucidate the best of the reconstruction method after proximal gastrectomy.

Condition or disease Intervention/treatment Phase
Gastric Cancer GastroEsophageal Cancer Procedure: Double tract anatomosis Procedure: Esophagogastrostomy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Double Tract Anastomosis and Esophagogastrostomy After Radical Proximal Gastrectomy: A Prospective, Randomized, Controlled Study
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2021
Estimated Study Completion Date : December 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Double tract anatomosis
After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers.
Procedure: Double tract anatomosis
After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers.

Active Comparator: Esophagogastrostomy
After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler.
Procedure: Esophagogastrostomy
After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler.




Primary Outcome Measures :
  1. Rate of reflux esophagitis after operation [ Time Frame: 12 months ]
    The rate of reflux esophagitis after operation will be assessed by gastrointestinal endoscopy with Los Angeles (LA) classification. the degree of reflux esophagitis will be classified as N, A, B, C or D level, and latter levels represent a more severe reflux esophagitis.


Secondary Outcome Measures :
  1. postoperative quality of life [ Time Frame: 12months ]
    Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - C30 questionnaire, the total score ranges from 30 to 126, and higher values represent a worse outcome.

  2. postoperative quality of life [ Time Frame: 12months ]
    Assessed by European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ) - STO22 questionnaire, the total score ranges from 22 to 88, and higher values represent a worse outcome.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients diagnosed as gastric or esophagogastric adenocarcinoma
  2. Age ranges from 18 to 80
  3. Karnofsky assessment no less than 70
  4. Completion of abdominal CT scan and ultrasound endoscopy
  5. Upper gastric cancer (cT1N0M0) or esophagogastric adenocarcinoma (diameter no more than 4 cm)
  6. radical proximal gastrectomy
  7. Normal blood routine examination and biochemical test

Exclusion Criteria:

  1. Patients need to undergo total gastrectomy or distal gastrectomy
  2. Female patients with pregnancy
  3. Not suitable for operation
  4. Patients have already joined other clinical trials

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613142


Contacts
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Contact: Xin Ji, M.D. +86 18601201053 18601201053@126.com

Sponsors and Collaborators
Beijing Cancer Hospital
Investigators
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Principal Investigator: Xin Ji, M.D. Beijing Cancer Hospital

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Responsible Party: Biao Fan, MD, Clinical Professor, Beijing Cancer Hospital
ClinicalTrials.gov Identifier: NCT03613142     History of Changes
Other Study ID Numbers: DTvsEG
First Posted: August 2, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Biao Fan, MD, Beijing Cancer Hospital:
Double tract
Esophagogastrostomy
Gastric cancer
GastroEsophageal Cancer

Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases