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Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

Randomized Controlled Trial on the Evaluation of Pylorus-ring in Pancreaticoduodenectomy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00639314
Enrollment
130
Registered
2008-03-20
Start date
2005-10-31
Completion date
2011-03-31
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ampullary Cancer, Bile Duct Cancer, Duodenal Cancer, Pancreatic Cancer, Pancreatitis

Keywords

pylorus-preserving pancreaticoduodenectomy, pylorus-resecting pancreaticoduodenectomy, randomized controlled trial, delayed gastric empty, quality of life

Brief summary

The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life (QOL).

Detailed description

The purpose of this study is to clarify whether resecting pylorus-ring decreases delayed gastric emptying after pancreaticoduodenectomy and improves postoperative quality of life(QOL)compared with preserving pylorus-ring. Delayed gastric emptying after pancreaticoduodenectomy are important to affect the postoperative course and QOL. However, there is no report that demonstrates the postoperative course between resecting pylorus-ring and preserving pylorus-ring. We conducted a prospective randomized trial on 130 patients who underwent pancreaticoduodenectomy comparing resecting pylorus-ring and preserving pylorus-ring. The primary endpoint was defined as the decrease of delayed gastric emptying. The secondary endpoints were QOL, mortality and morbidity, including pancreatic fistula, intra-abdominal hemorrhage, and intra-abdominal abscess. Patients were recruited into this study before surgery, on the basis of whether pancreatic head resection was anticipated at Wakayama Medical University Hospital(WMUH) for pancreatic head and periampullary disease, and appropriate informed consent was obtained. Exclusion criteria was 1) patients with severe complications which were possible to prolong hospital stay, 2) patients who were diagnosed inadequacy for this study by a physician, 3) patients with a previous gastric resection, and 4) patients without an informed consent.

Interventions

PROCEDUREpylorus-preserving pancreaticoduodenectomy

pylorus-preserving resection is division of the duodenum 3-4cm distal to the pylorus

PROCEDUREpylorus-resecting pancreaticoduodenectomy

In PrPD, the stomach is divided just above the pylorus ring. The nearly total stomach more than 95% was preserved.

Sponsors

Wakayama Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* On the basis of whether pancreatic head resection was anticipated at WMUH for pancreatic head and periampullary disease, and appropriate informed consent was obtained.

Exclusion criteria

* Patients with severe complications which were possible to prolong hospital stay * Patients who were diagnosed inadequacy for this study by a physician * Patients who could not be placed a pancreatic stent tube * Patients without an informed consent.

Design outcomes

Primary

MeasureTime frame
delayed gastric empty after pancreaticoduodenectomy1 month

Secondary

MeasureTime frame
evaluation of quality of life, early and late complications after pancreaticoduodenectomy2 years

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 29, 2026