SPADE Clinical Trial.

NCT07892183 | Recruiting

• 2 other identifiers: NCC2024-03242541820-1
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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 . 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

• 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

Conditions

Early Gastric Cancer; Adenocarcinoma of the Stomach; Proximal Gastric Cancer; SPADE Operation; Reflux Esophagitis Prevention; Laparoscopic Proximal Gastrectomy; Quality of Life; Gastric Function Preservation

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

Outcome Measures

Primary Outcomes (1)

• 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)

  1 Year

Study Arms (1)

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.

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

Interventions

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 PROCEDURE

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

SPADE Operation Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center, Korea

Goyang, Gyeonggido, 10408, South Korea

RECRUITING

Related Publications (8)

• 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.

  PMID: 30203207 BACKGROUND

• Jung 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.

  PMID: 28342130 BACKGROUND

• Ahn 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.

  PMID: 22821182 BACKGROUND

• Huh 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.

  PMID: 26468417 BACKGROUND

• Khalayleh 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.

  PMID: 33566106 BACKGROUND

• Tanioka 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.

  PMID: 31932938 BACKGROUND

• Masuzawa 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.

  PMID: 24310733 BACKGROUND

• Information 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.

  PMID: 34691807 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms; Esophagitis, Peptic

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Young-Woo Kim, Ph.D

CONTACT

+82-31-920-1635; youngwookim@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Cancer Policy and Population Health, National Cancer Center Graduate School of Cancer Science and Policy Staff Surgeon, Center for Gastric Cancer and Department of Surgery, Hospital, National Cancer Center

Study Record Dates

• First Submitted: October 7, 2026
• First Posted: October 23, 2026
• Study Start: June 25, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 23, 2026

Record last verified: 2026-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)