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Esophagitis, RefluxNCT05418920

Clinical Trial of Reconstruction After Proximal Gastrectomy

A study testing left-opening single-flap technique and double-flap group technique in people with Esophagitis, Reflux, run by Oncogastroenterology Committee of Chinese.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

1) To explore a simple, safe, post-proximal gastrectomy reconstruction method with good absorption and digestive function in order to improve patients' postoperative quality of life; 2) To fill the gap in the comparison of clinical efficacy between left-open single-flap technique and double-flap technique in this… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Esophagitis, Reflux
What is being tested?
left-opening single-flap technique and double-flap group technique
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
No sites listed yet
Study dates
1 Aug 2022to 31 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients aged 18-80 years, regardless of gender;
  • Siewert III of the esophagogastric junction adenocarcinoma: Stage Ⅰ(cT1-2N0M0) or adenocarcinoma of the upper part of the stomach： Stage Ⅰ(cT1-2N0M0), Stage II( cT1-2N1-3M0 / cT3-4N0M0), Stage III(cT3-4aN1-3M0); patients who are suitable for surgery according to the 8th AJCC clinical staging of gastric cancer;
  • Primary lesion diagnosed by preoperative endoscopic end pathology: tumor diameter <4 cm and located in the upper part of the stomach (including the esophagogastric junction), histologically confirmed adenocarcinoma;
  • Preoperative ASA score: I, II, or III;
  • Preoperative Karnofsky physical status score: ≥ 70%; or preoperative ECOG physical status score: ≤ 2;
  • No distant metastases (confirmed by preoperative chest X-ray, abdominal ultrasound, and upper abdominal CT); no peritoneal implant metastases (confirmed by laparoscopic exploration surgery);
  • R0 surgical outcome is expected to be obtained with radical gastrectomy of D2 proximal gastric cancer;
  • Patients and their families voluntarily participate in this study and sign the informed consent form after understanding the study content.

Who cannot join

  • Patients received any preoperative treatment, such as chemotherapy, radiotherapy, targeted therapy or immunotherapy; preoperative neoadjuvant chemotherapy recipients;
  • Patients with clinical stage exceeding Siewert III of the esophagogastric junction adenocarcinoma: Stage Ⅰ(cT1-2N0M0) or more than adenocarcinoma of the upper part of the stomach: Stage Ⅰ(cT1-2N0M0), Stage II(cT1-2N1-3M0/cT3-4N0M0), Stage III(cT3-4aN1-3M0);
  • Patients with acute infections, especially biliary tract infections;
  • Patients with complications of gastric cancer (bleeding, perforation, obstruction) requiring emergency surgery;
  • Patients with uncorrectable coagulation dysfunction;
  • Patients with vital organ failure, such as heart, lung, liver, brain, kidney, etc.
Show all 19Show fewer
  • Severe central nervous system disease, mental disorders, or impaired consciousness;
  • Pregnant or lactating women;
  • Patients with distant metastases;
  • Patients with a primary tumor at another site diagnosed within the past 5 years;
  • Preoperative ASA score: ≥ IV;
  • Preoperative ECOG physical status score: ≥ 2;
  • History of continuous systemic corticosteroid therapy within the past 1 month;
  • History of unstable angina, myocardial infarction, cerebral infarction, or cerebral hemorrhage within the past 6 months;
  • Patients with concurrent surgical treatment of other diseases;
  • Patients with immunodeficiency, immunosuppression, or autoimmune diseases (organ transplant requiring immunosuppressive therapy within the past 5 years, allogeneic bone marrow transplant patients, taking immunosuppressive drugs, etc.);
  • Patients with concurrent participation in other clinical studies;
  • Patients refusing to sign an informed consent form to participate in this study;
  • Preoperative imaging: regional fusion of enlarged lymph nodes (maximal diameter > 3 cm).

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Xiaohua Li, MD contact

+8613474299901

xjyylixiaohua@163.com

Gang Ji, MD contact

+8613572152581

xijingweichang@163.com

About this study

Official title: Comparing the Efficacy of Double-flap Technique Versus Single-flap Technique After Proximal Gastrectomy: a Multicentre Randomized Controlled Trial

  1. To explore a simple, safe, post-proximal gastrectomy reconstruction method with good absorption and digestive function in order to improve patients' postoperative quality of life; 2) To fill the gap in the comparison of clinical efficacy between left-open single-flap technique and double-flap technique in this specialized field in China; 3) To utilize the experience and foundation of gastrointestinal surgery in the treatment of gastric cancer and integrate the advantageous resources in China; 4) To establish a large-sample, multicenter randomized clinical study in order to promote the establishment and improvement of relevant norms of gastrointestinal reconstruction
Read the detailed description

Gastric cancer is the fifth most common cancer worldwide and the third leading cause of cancer-related deaths each year. Although the incidence of gastric cancer has decreased worldwide compared to the past, the incidence of esophagogastric junction cancer and upper 1/3 gastric cancer is gradually increasing. Currently, the main treatment for esophagogastric junction cancer and upper gastric cancer is surgery. However, there is no clinical consensus on the choice of surgical approach for these patients. Compared with total gastrectomy, proximal gastrectomy can preserve the physiological function of the stomach and has great advantages in nutrient absorption, thus it has been widely accepted in Asian countries.

However, the risk of developing reflux esophagitis after proximal gastrectomy is high, which seriously affects patients' postoperative quality of life. In order to reduce the occurrence of postoperative complications, clinicians continue to improve the methods of GI reconstruction. Currently, the common methods of GI reconstruction after proximal gastrectomy include esophagogastrostomy (EG), jejunal intubation (JI), jejunal pouch intubation (JPI), and dual-tract reconstruction (DTR). However, the choice of the optimal reconstruction method after proximal gastrectomy remains controversial, and there is no standard approach to GI reconstruction. In 2016, Kuroda et al. reported a new surgical approach with a double-flap technique after proximal gastrectomy and showed satisfactory short-term outcomes compared with conventional esophagogastric anastomosis. At the 1-year postoperative follow-up, no reflux esophagitis was detected in all patients. At the same time, the rate of anastomotic stenosis was noteworthy.

This study will be the first attempt at a left-open single-flap technique, which was modified from the double-flap technique. The short-term outcome was satisfactory in all patients. This study will establish a large sample, multicenter randomized clinical study. By exploring a simple, safe, good absorption and digestive function method of post-proximal gastrectomy reconstruction to improve patients' postoperative quality of life and fill the gap in the comparison of clinical efficacy between left-open single-flap technique and double-flap technique in this specialized field. This will promote the establishment and improvement of the specifications related to gastrointestinal reconstruction.

Being tested
left-opening single-flap technique, double-flap group technique
Keywords
left open single-flap technique, proximal gastrectomy
Medical subject headings
Esophagitis, Peptic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • left-opening single-flap techniqueProcedure or surgery

    left-opening single-flap technique

  • double-flap group techniqueProcedure or surgery

    double-flap group technique

Study groups in NCT05418920
Study groupRoleWhat they receive
the trial group (left-opening single-flap group)Experimentalleft-opening single-flap group
Receives: Procedure: left-opening single-flap technique
the control group (double-flap group)Active comparatordouble-flap group
Receives: Procedure: double-flap group technique

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of reflux esophagitis

    Incidence of reflux esophagitis

    Measured: 12 months

Secondary outcomes (6)

  1. Overall postoperative complication rate

    Overall postoperative complication rate

    Measured: 30 days

  2. Incidence of anastomotic fistula

    Incidence of anastomotic fistula

    Measured: 30 days

  3. Operation time

    Operation time

    Measured: intraoperative

  4. Bleeding loss volume

    Bleeding loss volume

    Measured: intraoperative

  5. incidence of anastomotic stricture

    incidence of anastomotic stricture

    Measured: 30 days

  6. Incidence of reflux esophagitis

    Incidence of reflux esophagitis

    Measured: 6 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2022
  2. Study start1 Aug 2022 (estimated)
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Jul 2027 (estimated)

Resources

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
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05418920
Sponsor's protocol ID
single-flap technique
Status last verified
Jun 2022
First submitted
6 Jun 2022
Last updated
5 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yang QC, Wang WD, Mo ZC, Yue C, Zhou HK, Gao RQ, Yu J, Dong DH, Liu JQ, Wei JP, Yang XS, Ji G, Li XH. Study protocol for comparing the efficacy of left-open single-flap technique versus double-flap technique after proximal gastrectomy: A multicenter randomized controlled trial. Front Oncol. 2022 Nov 17;12:973810. doi: 10.3389/fonc.2022.973810. eCollection 2022.

    PubMed 36465382

Questions about this trial

What is this clinical trial studying?

A study testing left-opening single-flap technique and double-flap group technique in people with Esophagitis, Reflux, run by Oncogastroenterology Committee of Chinese.

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 19 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: opening soon, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Xiaohua Li, MD (+8613474299901, xjyylixiaohua@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of reflux esophagitis (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05418920, which also lists 1 linked publication.

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 5 Jul 2022.

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