Early Gastric CancerSPADENCT07892183
SPADE Clinical Trial.
A study testing Spade-Shaped Anastomosis after Laparoscopic or Robotic Proximal Gastrectomy Using Double Suture Anchoring between the Posterior Wall of the Esophagus and the Anterior Wall of the Stomac in people with Early Gastric Cancer and Adenocarcinoma of the Stomach, run by National Cancer Center, Korea at 1 site in South Korea.
Trial summary
Purpose: This multicenter, prospective, single-arm phase 2 clinical trial aims to evaluate the safety, feasibility, and clinical outcomes of the SPADE operation (Spade-Shaped Anastomosis) in patients undergoing laparoscopic or robotic proximal gastrectomy for early gastric cancer located in the upper stomach . Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Early Gastric Cancer, Adenocarcinoma of the Stomach, Proximal Gastric Cancer
- What is being tested?
- Spade-Shaped Anastomosis after Laparoscopic or Robotic Proximal Gastrectomy Using Double Suture Anchoring between the Posterior Wall of the Esophagus and the Anterior Wall of the Stomac
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Jun 2025to 31 Dec 2030
- Phase
- Interventional
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ① Histologically confirmed diagnosis of gastric adenocarcinoma by biopsy.
- Adult patients aged 20 years or older.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
- ④ American Society of Anesthesiologists (ASA) physical status classification of class I to III.
- ⑤ Patients who have received a full explanation of the study purpose and procedures, and voluntarily signed the informed consent form approved by the Institutional Review Board.
- ⑥ Patients eligible for proximal gastrectomy satisfying the following oncologic characteristics on preoperative evaluation:
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- Tumor location: Upper third of the stomach (High body, cardia, fundus, gastroesophageal junction [Siewert III])
- Tumor size: 4 cm or less
- Preoperative clinical stage: T1N0, T1N1, T2N0, T2N1 (any differentiation)
- Preoperative clinical stage: T3N0, T3N1 (well or moderate differentiation)
- Expected residual stomach: 60% or more after surgery
Who cannot join
- Patients for whom total gastrectomy is the only appropriate treatment (e.g., presence of additional gastric cancer lesions in the distal stomach).
- ② Patients requiring concomitant resection of other organs due to other diseases.
- ③ Patients with other malignancies that may affect gastric function preservation indicators:
- History of cancer in other organs.
- Presence of concurrent cancer in other organs.
- History of previous gastric resection surgery. ④ Vulnerable populations: patients lacking decision-making capacity, pregnant women, or those planning pregnancy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
National Cancer Center, Korea
Goyang, Gyeonggido, 10408
Young-Woo Kim, Ph.D, +82-31-920-1635, youngwookim@ncc.re.kr
Hongman Yoon, Ph.D, red1000@ncc.re.kr
About this study
Official title: Spade-Shaped Anastomosis After Laparoscopic or Robotic Proximal Gastrectomy Using Double Suture Anchoring Between the Posterior Wall of the Esophagus and the Anterior Wall of the Stomach (SPADE Operation): a Multicenter Prospective Clinical Trial.
Purpose: This multicenter, prospective, single-arm phase 2 clinical trial aims to evaluate the safety, feasibility, and clinical outcomes of the SPADE operation (Spade-Shaped Anastomosis) in patients undergoing laparoscopic or robotic proximal gastrectomy for early gastric cancer located in the upper stomach
. Background: While proximal gastrectomy (removing only the upper part of the stomach) offers nutritional advantages over total gastrectomy, it often leads to significant postoperative reflux esophagitis
Read more
- The SPADE technique was developed to prevent this by creating an artificial anti-reflux mechanism (angle of His and pseudo-fornix) using double suture anchoring between the esophagus and the stomach
Study Plan:
Participants: The study will enroll approximately 159 patients with tumors (size ≤ 4 cm) located in the upper third of the stomach who are eligible for gastric function-preserving surgery . Intervention: All participants will undergo laparoscopic or robotic proximal gastrectomy followed by the SPADE reconstruction method
. Primary Objective: The primary goal is to determine the incidence of endoscopic reflux esophagitis at one year postoperatively
. Secondary Objectives: Investigators will also monitor postoperative reflux symptoms, nutritional parameters (such as weight, hemoglobin, and vitamin B12 levels), surgical complications, quality of life, and 3-year survival rates
. Hypothesis: The researchers hypothesize that the SPADE operation is a safe and effective surgical approach that can provide equivalent reflux prevention (a target rate of approximately 2.9%) compared to existing complex reconstruction methods, while maintaining the benefits of preserving gastric function
Read the detailed description
Background and Rationale: Total gastrectomy has been the standard treatment for proximal gastric cancer, but it often results in a significant decline in quality of life (QoL) due to malnutrition, weight loss, and malabsorption
- Proximal gastrectomy (PG) is an alternative that preserves gastric function; however, conventional reconstruction methods frequently lead to severe reflux esophagitis
- To address this, the SPADE (Spade-Shaped Anastomosis) technique was developed. It aims to prevent reflux by creating an artificial anti-reflux mechanism, including the angle of His and a pseudo-fornix, through double suture anchoring between the posterior wall of the esophagus and the anterior wall of the stomach
- This study is designed to validate the safety and clinical efficacy of this newly developed procedure
Study Design and Population: This is a multicenter, prospective, single-arm phase 2 clinical trial
- The study will enroll a total of 159 patients (including a 10% dropout rate) diagnosed with early gastric cancer in the upper third of the stomach
- Eligible participants must have a tumor size of 4 cm or less and meet specific preoperative clinical stages (e.g., T1-T2N0/1 or T3N0/1 depending on differentiation) with an expected remnant stomach of 60% or more
Surgical Procedure (SPADE Operation):
Resection: Surgeons will perform laparoscopic or robotic proximal gastrectomy with D1+ lymph node dissection
- The esophagus is resected just above the esophagogastric junction (EGJ)
Reconstruction: The proximal remnant stomach and the distal esophagus (3 cm above the transected edge) are fixed with interrupted sutures on both sides to create the "spade" shape . Anastomosis: A linear opening is made in the stomach, and the anterior and posterior walls of the esophagus and stomach are sutured using continuous barbed sutures to secure the intra-abdominal positioning of the anastomosis
. Evaluation and Follow-up: Patients will undergo a structured follow-up protocol at 3 weeks, and 3, 6, 12, 18, 24, 30, and 36 months postoperatively
. Primary Endpoint: The incidence of endoscopic reflux esophagitis at 12 months, graded by the Los Angeles (LA) classification
. Secondary Endpoints: Postoperative reflux symptoms (Visick score), changes in nutritional parameters (body weight, hemoglobin, albumin, vitamin B12, etc.), surgical complications (Clavien-Dindo classification), and Quality of Life (using EORTC QLQ-C30 and STO22)
. Survival: 3-year overall survival (OS) and disease-free survival (DFS) will also be monitored
.
- Conditions
- Early Gastric Cancer, Adenocarcinoma of the Stomach, Proximal Gastric Cancer, SPADE Operation, Reflux Esophagitis Prevention, Laparoscopic Proximal Gastrectomy
- Being tested
- Spade-Shaped Anastomosis after Laparoscopic or Robotic Proximal Gastrectomy Using Double Suture Anchoring between the Posterior Wall of the Esophagus and the Anterior Wall of the Stomac
- Keywords
- SPADE Operation (Spade-Shaped Anastomosis), Early Gastric Cancer, Proximal Gastrectomy, Reflux Esophagitis, Angle of His Reconstruction, Double Suture Anchoring, Gastric Function Preservation, Quality of Life (QoL), Phase 2 Feasibility Study
- Medical subject headings
- Stomach Neoplasms, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spade-Shaped Anastomosis after Laparoscopic or Robotic Proximal Gastrectomy Using Double Suture Anchoring between the Posterior Wall of the Esophagus and the Anterior Wall of the StomacProcedure or surgery
The SPADE operation (Spade-Shaped Anastomosis) is a specialized reconstruction technique performed following a laparoscopic or robotic proximal gastrectomy for patients with upper-third early gastric cancer
- The intervention involves several key technical steps designed to preserve gastric function and prevent postoperative reflux:
Surgical Approach and Resection: The procedure begins with a laparoscopic or robotic proximal gastrectomy accompanied by D1+ lymph node dissection
- Surgeons must preserve the hepatic branch of the vagus nerve in all patients
- The esophagus is resected just above the esophagogastric junction (EGJ) using a linear stapler
Anchoring and Fixation: To create an anti-reflux mechanism, the proximal part of the residual stomach and the distal esophagus (3 cm above the transected edge) are fixed using single interrupted sutures on both sides
- This "double suture anchoring" ensures the anastomosis remains in an intra-abdominal position and creates an ar
| Study group | Role | What they receive |
|---|---|---|
| SPADE Operation Arm | Experimental | All participants enrolled in this single-arm study will undergo the SPADE operation (Spade-Shaped Anastomosis). This procedure is performed following a laparoscopic or robotic proximal gastrectomy with D1+ lymph node dissection for patients with early gastric cancer located in the upper third of the stomach
.
The intervention specifically focuses on a unique reconstruction technique designed to prevent reflux:
Anti-reflux Mechanism: The surgeons fix the posterior wall of the distal esophagus (approximately 3 cm above the transected edge) to the proximal part of the residual stomach using single interrupted sutures on both sides
* This creates a "spade" shape and reconstructs an artificial angle of His and a pseudo-fornix to maintain the anastomosis in an intra-abdominal position
Anastomosis: The opening is created 3 cm inferior to the proximal end of the remnant stomach, and the anterior and posterior walls of the esophagus and stomach are joined using continuous barbed sutures. Receives: Procedure: Spade-Shaped Anastomosis after Laparoscopic or Robotic Proximal Gastrectomy Using Double Suture Anchoring between the Posterior Wall of the Esophagus and the Anterior Wall of the Stomac |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Endoscopic Reflux Esophagitis at 1 Year
The primary goal is to determine the rate of reflux esophagitis exactly 12 months postoperatively
- This will be assessed via endoscopy and graded according to the Los Angeles (LA) classification (Grades A, B, C, and D)
Measured: 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start25 Jun 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Early Gastric CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Center, Korea
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Young-Woo Kim, National Cancer Center, Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892183
- Sponsor's protocol ID
- NCC2024-0324
- Other IDs
- 2541820-1
- Acronym
- SPADE
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cho M, Son T, Kim HI, Noh SH, Choi S, Seo WJ, Roh CK, Hyung WJ. Similar hematologic and nutritional outcomes after proximal gastrectomy with double-tract reconstruction in comparison to total gastrectomy for early upper gastric cancer. Surg Endosc. 2019 Jun;33(6):1757-1768. doi: 10.1007/s00464-018-6448-x. Epub 2018 Sep 10.
PubMed 30203207Jung DH, Lee Y, Kim DW, Park YS, Ahn SH, Park DJ, Kim HH. Laparoscopic proximal gastrectomy with double tract reconstruction is superior to laparoscopic total gastrectomy for proximal early gastric cancer. Surg Endosc. 2017 Oct;31(10):3961-3969. doi: 10.1007/s00464-017-5429-9. Epub 2017 Mar 24.
PubMed 28342130Ahn SH, Lee JH, Park DJ, Kim HH. Comparative study of clinical outcomes between laparoscopy-assisted proximal gastrectomy (LAPG) and laparoscopy-assisted total gastrectomy (LATG) for proximal gastric cancer. Gastric Cancer. 2013 Jul;16(3):282-9. doi: 10.1007/s10120-012-0178-x. Epub 2012 Jul 22.
PubMed 22821182Huh YJ, Lee HJ, Oh SY, Lee KG, Yang JY, Ahn HS, Suh YS, Kong SH, Lee KU, Yang HK. Clinical Outcome of Modified Laparoscopy-Assisted Proximal Gastrectomy Compared to Conventional Proximal Gastrectomy or Total Gastrectomy for Upper-Third Early Gastric Cancer with Special References to Postoperative Reflux Esophagitis. J Gastric Cancer. 2015 Sep;15(3):191-200. doi: 10.5230/jgc.2015.15.3.191. Epub 2015 Sep 30.
PubMed 26468417Khalayleh H, Kim YW, Man Yoon H, Ryu KW, Kook MC. Evaluation of Lymph Node Metastasis Among Adults With Gastric Adenocarcinoma Managed With Total Gastrectomy. JAMA Netw Open. 2021 Feb 1;4(2):e2035810. doi: 10.1001/jamanetworkopen.2020.35810.
PubMed 33566106Tanioka T, Waratchanont R, Fukuyo R, Saito T, Umebayashi Y, Kanemoto E, Kobayashi K, Nakagawa M, Inokuchi M. Surgical and nutritional outcomes of laparoscopic proximal gastrectomy versus total gastrectomy: a meta-analysis. Surg Endosc. 2020 Mar;34(3):1061-1069. doi: 10.1007/s00464-019-07352-2. Epub 2020 Jan 13.
PubMed 31932938Masuzawa T, Takiguchi S, Hirao M, Imamura H, Kimura Y, Fujita J, Miyashiro I, Tamura S, Hiratsuka M, Kobayashi K, Fujiwara Y, Mori M, Doki Y. Comparison of perioperative and long-term outcomes of total and proximal gastrectomy for early gastric cancer: a multi-institutional retrospective study. World J Surg. 2014 May;38(5):1100-6. doi: 10.1007/s00268-013-2370-5.
PubMed 24310733Information Committee of the Korean Gastric Cancer Association. Korean Gastric Cancer Association-Led Nationwide Survey on Surgically Treated Gastric Cancers in 2019. J Gastric Cancer. 2021 Sep;21(3):221-235. doi: 10.5230/jgc.2021.21.e27. Epub 2021 Oct 1.
PubMed 34691807