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Status unknownNCT05088564Updated Oct 25, 2022

Efficacy of Hemi-double-stapling Technique

An interventional study of Hand-sewn and Hemi-double stapling in Periampullar Disease, sponsored by Gangnam Severance Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2022-10-25.

Sponsored by Gangnam Severance Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Apr 2021, registered Aug 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
180
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study summary

Surgical stapler is used in all areas of surgical operation. Surgical stapler has been used in various surgical fields for a long time, so its stability has already been proven. After gastrectomy or colectomy, the hemi-double stapling technique, which is an improved double stapling technique, has been applied as an anastomosis method using a stapler.

In the duodenojejunal anastomosis after PPPD, the hemi-double stapling method can be applied to preserve the pyloric branch of the vagus nerve and the branch of the right gastric artery to ensure sufficient blood supply. Ultimately, it is expected to shorten the anastomosis time as well as reduce the frequency of delayed gastric emptying. In addition, the work of physically expanding the pylorus to insert the circular anastomosis is also thought to reduce gastric emptying delay.

Read the detailed description

(1) Stapling technique

  1. Make purse-string suture on jejunum at the point of duodenojejunostomy
  2. Insert Anvil into jejunem
  3. Make incision of 3-4 centimeters at anterior side of antrum
  4. Long Kelly forceps are inserted into the stomach to dilate the pylorus
  5. A 25 mm end-to-end anastomosis (EEA) stapler is inserted into the stomach and passed through the pylorus.
  6. The needle of EEA stapler is pierced through the lower part of the stapler line where the duodenum has been resected
  7. The EEA stapler is combined with the anvil and anastomosis is performed
  8. The incision on the stomach is sutured through a linear stapler
  9. Reinforcement suture for stapler line

(2) Postoperative management

  • Diet build up as same manner of hand-sewn group (3) Postoperative follow-up
  • All postoperative complication, delayed gastric emptying, intraperitoneal abscess, postoperative pancreatic fistula, postpancreatectomy hemorrhage, hospital stay, reoperation, readmission and 2-months mortality.
02

Conditions studied

  • Periampullar Disease
03

In context

Lead sponsor

Gangnam Severance Hospital is the lead sponsor of 141 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. pylorus-preserving pancreaticoduodenectomy
  2. ECOG scale 0-1
  3. Age > 19
  4. Appropriate organ function as below i.WBC : ≥2500 mm3, ≤14000 mm3 ii.Hemoglobin : ≥9.0 g/dL iii.Platelet : ≥100,000 mm3 iv.Total bilirubin : ≤2.0 mg/dL (except for occlusive jaundice) v.Creatinine : ≤2.0 mg/dL
  5. patient who can understand and sign the informed consent

Exclusion criteria

Exclusion Criteria:

  1. previous history of gastrectomy
  2. ulcerative scar around ampulla of duodenum on endoscopy
  3. previous history of upper abdomen surgery (open)
  4. Emergency
  5. Severe ischemic heart disease
  6. Severe hepatic failure by liver cirrhosis or hepatitis
  7. Severe respiratory failure that requires oxygene inhalation
  8. Chronic renal failure that requires hemodialysis
  9. Expecting combine resection of other organ
  10. Immunosuppressive therapy
  11. Accompanying cancer with potential for adverse events
  12. Severe psychologic or neurologic disease
  13. drug or alcohol addiction
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    I (Hand-sewn group)

    Doudenojejunal anastomosis by hand-swen method

    Procedure: Hand-sewn

  • Active comparator
    II (Stapling group)

    Doudenojejunal anastomosis by hemi-double-stapling method

    Procedure: Hemi-double stapling

Interventions

  • ProcedureHand-sewn

    Doudenojejunal anastomosis by hand-sewn method

  • ProcedureHemi-double stapling

    Doudenojejunal anastomosis by hemi-double-stapling method "EEA25 - Covidien EEA Circular Stapler DST Series 25.0mm x 4.8mm" is used for anastomosis

06

What researchers measure

Primary outcomes

  1. Grade of delayed gastric emptying by ISGPS

    Delayed gastric emptying will be evaluated at postoperative 21 day using International study group of pancreatic surgery (ISGPS) classification. According to ISGPS classification, delayed gastric emptying is divided into three grades from A to C. Grade C means worse than grade A.--\>Unit of Measure: Grade A,B,C

    Time frame: At postoperative 21 day

Secondary outcomes

  1. hospital stay

    Duration (days) of hospital stay, which means interval between operation day and discharge day will be checked up to postoperative 2 months. --\> Unit of Measure: days

    Time frame: At postoperative 21 day

Other outcomes

  1. intraperitoneal abscess

    Intraperitoneal abscess will be evaluated using 2 point scale (yes or no) at postoperative 2 months. * Unit of Measure: Yes, No

    Time frame: at postoperative 2 months

  2. Incidence of reoperation/ readmission

    The incidence of reoperation and readmission will be evaluated using 2 point scale (yes or no) at postoperative 2 months.--\> Unit of Measure: Yes, No

    Time frame: At postoperative 21 day

07

Study locations

1 of 1 sites recruiting
  • Gangnam Severance Hospital
    Seoul, Korea, Republic of
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05088564
Lead sponsor
Gangnam Severance Hospital
Responsible party
Joon Seong Park (Professor, Gangnam Severance Hospital) — Principal investigator
First posted
Oct 22, 2021
Start date
Apr 23, 2021
Primary completion
Apr 22, 2024 (estimated)
Completion
Apr 22, 2024 (estimated)
Last update
Oct 25, 2022

Study contacts

Joon Seoung Park
Contact
jspark330@yuhs.ac
82-2-2019-2444
Joon Seoung Park
principal investigator · GangnamSeverance Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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