Trial reportWorld journal of surgery2019
Safety and Feasibility of Linear Stapling Device with Bioabsorbable Polyglycolic Acid Sheet for Duodenal Closure in Gastric Cancer Surgery: A Multi-institutional Phase II Study.
Trial report in World journal of surgery, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
9 citing papers in PubMed, 15 citations in OpenAlex.
- Mechanisms of polyglycolic acid sheet-induced abdominal wall adhesions in hamsters.Surgery today · 2025Article
- Review
- Importance of duodenal stump reinforcement to prevent stump leakage after gastrectomy: a large-scale multicenter retrospective study (KSCC DELICATE study).Gastric cancer : official journal of the International Gastric Cancer Association and the Japanese Gastric Cancer Association · 2024Article
- Modified Q-type purse-string suture duodenal stump embedding method for laparoscopic gastrectomy for gastric cancer.BMC surgery · 2024Article
- Reinforcement methods of duodenal stump after laparoscopic gastrectomy for gastric cancer: A review.Heliyon · 2023Review
- Intracorporeal delta-shaped anastomosis without suturing technique in laparoscopic colectomy using a linear stapling device with bioabsorbable polyglycolic acid sheet.Techniques in coloproctology · 2022Article
- Risk Factors for Duodenal Stump Leakage after Laparoscopic Gastrectomy for Gastric Cancer.Journal of gastric cancer · 2020Article
- Single Purse-String Suture for Reinforcement of Duodenal Stump During Laparoscopic Radical Gastrectomy for Gastric Cancer.Frontiers in oncology · 2019Article
- Does Intestinal Peristalsis Cause Suture Failure After Instrument Suture?In vivo (Athens, Greece)Article
Corrections and comments
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Authors and funding
6 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundDuodenal stump fistula (DSF) after gastrectomy is of low frequency but a critical complication in gastric cancer surgery. Manual oversewing for reinforcement of the duodenal stump is not applicable when free longitudinal margin is short and has technical difficulties in laparoscopic surgery. This trial evaluated the safety and feasibility of using a linear stapler with bioabsorbable polyglycolic acid (PGA) sheet for duodenal stump closure and reinforcement in gastric cancer surgery.
methodsThis multi-institutional, prospective phase II trial included gastric cancer patients who were scheduled to undergo distal or total gastrectomy with R-Y reconstruction. In all cases, duodenum was transected using a linear stapler with PGA sheet. The primary endpoint was the incidence of postoperative DSF. Sample size was set at 100 patients considering an expected value of 3% and threshold value of 8% with one-sided testing at a 10% significance level.
resultsBetween June 2014 and June 2015, a total of 100 patients were registered in this trial. Postoperative DSF was observed in two cases (2.0%, 90% CI 0.4-6.2%) which was developed on postoperative days 13 and 20. Intraoperative bleeding at the duodenal stump staple line was observed in one case but was easily controlled without additional suturing. Postoperative bleeding was not observed in any of the cases.
conclusionThis study suggested that the use of PGA sheet as a reinforcement material for closure of the duodenal stump during gastrectomy for gastric cancer is both safe and feasible. Trial registration number UMIN 000014398.
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