ComplicationsDTA>ANCT02288728
Double Tract Anastomosis and Gastric Tube Anastomosis to Proximal Gastrectomy
A study testing Gastric tube anastomosis and Double-track anastomosis in people with Complications and Quality of Life, run by Jian-Kun Hu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Complications, Quality of Life, Remnant Gastritis
- What is being tested?
- Gastric tube anastomosis and Double-track anastomosis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- Dec 2014to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Remnant Stomach-jejunum Double Tract Anastomosis vs. Gastric Tube Anastomosis to Proximal Gastrectomy of Early Gastric Cancer- a Randomized Controlled Trial
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.
Read the detailed description
Standard Operating Procedure (SOP)
- Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
- Randomization: Intraoperative evaluation found that R0, proximal gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.
- Surgical procedures: The surgical treatments is adopted the proximal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Group A take the gastric tube anastomosis and Group B take the double-track anastomosis (the reconstruction method is described in the intervention section of study groups). The two study will take the similar surgical procedures except for the digestive track reconstruction.
- Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
- Follow-up: The follow-up of this study divide into two parts, the postoperative quality of life and tumor characteristics outcomes. The information of the postoperative quality of life is collected by the European Organization for Research and Treatment of Cancer (EORCT) QLQ-C30 and STO-22 questionnaires. At the postoperative 12 moths, the upper gastrointestinal scope is needed to examine the reflux esophagitis and the remnant gastritis according to Los Angeles Classification of esophagitis. The tumor related outcomes included long-term postoperative complications, recurrence type, relapse free survival (months) and the overall survival (months).
- Conditions
- Complications, Quality of Life, Remnant Gastritis, Reflux Esophagitis
- Being tested
- Gastric tube anastomosis, Double-track anastomosis
- Keywords
- Proximal gastrectomy, quality of life, mortality, morbidity
- Medical subject headings
- Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric tube anastomosisProcedure or surgery
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.)
Double-track anastomosisProcedure or surgery
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.)
| Study group | Role | What they receive |
|---|---|---|
| Group B (double-track anastomosis) | Experimental | Patients in the Group B will received the double-track anastomosis with proximal gastrectomy. Receives: 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. Receives: Procedure: Gastric tube anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative mortality and morbidity
Measured: postoperative period (30 days)
Secondary outcomes (4)
Intraoperative mortality and morbidity
Measured: Intraoperative
postoperative quality of life
Measured: Postoperative period (at least one year)
remnant gastritis
Evaluated by Los Angeles classification. Reference: Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut 1999; 45: 172-80.
Measured: postoperative period (one year)
reflux esophagitis
Evaluated by Los Angeles classification. Reference: Lundell LR, Dent J, Bennett JR, et al. Endoscopic assessment of oesophagitis: clinical and functional correlates and further validation of the Los Angeles classification. Gut 1999; 45: 172-80.
Measured: Postoperative period (one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Not enough paticipants enroll in this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jian-Kun Hu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jian-Kun Hu, West China Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288728
- Sponsor's protocol ID
- WCH-GC-01
- Acronym
- DTA>A
- Status last verified
- Dec 2017
- First submitted
- 29 Sep 2014
- Last updated
- 11 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remnant Stomach-jejunum Double Tract Anastomosis vs. Gastric Tube Anastomosis to Proximal Gastrectomy of Early Gastric Cancer- a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02288728
- Acronym / sponsor ID
- DTA>A / WCH-GC-01
- Conditions
- Complications, Quality of Life, Remnant Gastritis, Reflux Esophagitis
- Keywords
- Proximal gastrectomy, quality of life, mortality, morbidity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Not enough paticipants enroll in this study.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Jian-Kun HuUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 11 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Standard Operating Procedure (SOP)
- Preoperative evaluation Patients satisfied with inclusion/exclusion criteria will be informed to join in the clinical study and signature the inform consent.
- Randomization: Intraoperative evaluation found that R0, proximal gastrectomy can be performed, the case will entrance into the Randomization period. Random numbers are computer-generated, with the third party applications.
- Surgical procedures: The surgical treatments is adopted the proximal gastrectomy according to the Japanese Gastric Cancer treatments guidelines, 2010, Version 3. Group A take the gastric tube anastomosis and Group B take the double-track anastomosis (the reconstruction method is described in the intervention section of study groups). The two study will take the similar surgical procedures except for the digestive track reconstruction.
- Postoperative recovery: Postoperative recovery period need to collect those relevant parameters of all the patients. All the relevant parameters had definitely definition in the Case Report Form of this study which included the preoperative, intraoperative and postoperative clinicopathologic characteristics.
- Follow-up: The follow-up of this study divide into two parts, the postoperative quality of life and tumor characteristics outcomes. The information of the postoperative quality of life is collected by the European Organization for Research and Treatment of Cancer (EORCT) QLQ-C30 and STO-22 questionnaires. At the postoperative 12 moths, the upper gastrointestinal scope is needed to examine the reflux esophagitis and the remnant gastritis according to Los Angeles Classification of esophagitis. The tumor related outcomes included long-term postoperative complications, recurrence type, relapse free survival (months) and the overall survival (months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group B (double-track anastomosis) | Experimental | Procedure: Double-track anastomosisPatients in the Group B will received the double-track anastomosis with proximal gastrectomy. |
| Group A (Gastric tube anastomosis) | Other | Procedure: Gastric tube anastomosisPatients in the Group A (Gastric tube anastomosis) will take the gastric tube anastomosis with proximal gastrectomy. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric tube anastomosisIn 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.) | Procedure or surgery | Group A (Gastric tube anastomosis) |
| Double-track anastomosisDouble-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.) | Procedure or surgery | Group B (double-track anastomosis) |
Primary outcome
postoperative mortality and morbidity
Time frame: postoperative period (30 days)
4 secondary outcomes
Intraoperative mortality and morbidity
Time frame: Intraoperative
postoperative quality of life
Time frame: Postoperative period (at least one year)
remnant gastritis
Time frame: postoperative period (one year)
reflux esophagitis
Time frame: Postoperative period (one year)
Results and safety
The study was stopped early (reason given: Not enough paticipants enroll in this study.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric tube anastomosis and Double-track anastomosis in people with Complications and Quality of Life, run by Jian-Kun Hu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not enough paticipants enroll in this study.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative mortality and morbidity (time frame: postoperative period (30 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2017.