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Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial

18 Years
80 Years
Open (Enrolling)
Periampullary Carcinoma Nos

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Trial Information

Comparison of Pancreas-sparing Duodenectomy With Pancreatoduodenectomy for Early-stage Periampullary Carcinoma:A Prospective Non-Randomized Trial

Pancreaticoduodenectomy (PD) is commonly used for periampullary carcinoma (PC). In recent
years, morbidity and mortality rates following PD have decreased, but the operative stress
induced by pancreatectomy is considerable. Less-invasive surgery should thus be elected for
PC without pancreatic and diffuse lymph node involvement. From the perspective of
organ-preserving resection, pancreas-sparing duodenectomy (PSD) represents an attractive
option for selected periampullary tumors, and offers an alternative to PD.

Previous reports have described PSD for benign, premalignant and some selected malignant
conditions of duodenum, and have emphasized this procedure as a safe and effective treatment
associated with good quality of life. However, use of PSD for PC is still
controversial.Available data about PSD for PC and published data from the follow-up
evaluation in the literature are still limited.

Given the fact that 20%-60% pT1/pT2 patients have regional lymph node metastasis, regional
lymph node dissection should be essential for PC. However, lymphadenectomy has never been
promoted as a regular procedure of PSD.The aim of the present study was to investigate the
feasibility, safety, and long-term results of PSD with regional lymphadenectomy for
early-stage (pTis/pT1/pT2) periampullary cancers.

Inclusion Criteria:

- Pathologically proven periampullary carcinoma (including cancers of distal common
bile duct, ampulla or papilla of Vater)

- Pre- and intra-operative stage(CT, EU stage):pTis or pT1 or pT2, N0 or N1, M0

- ASA score: < 3

- Liver function:Child-Pugh A

- No history of other cancers

- No history of preoperative chemotherapy or radiotherapy

- Written informed consent

Exclusion Criteria:

- There are concurrent cancers or the patients have been treated due to other type of
cancers before diagnosed as periampullary carcinoma

- Pre- and intra-operative stage: more advanced than T2,or with remote metastasis

- The Patients received other non-surgical therapy, such as chemotherapy,
immunotherapy, radiotherapy or endoscopic therapy

- The Patients received upper abdominal surgery

- ASA score: ≥ 3

- Liver function:Child-Pugh B or C

- Pregnancy patients

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease free survival

Outcome Description:

It is an average time peroid.

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Ping Bie, M.D.,Ph.D.

Investigator Role:

Study Director

Investigator Affiliation:

Institute of Hepatobiliary Surgery, Southwest Hospital, Third Military Medical University


China: Ethics Committee

Study ID:




Start Date:

May 2005

Completion Date:

May 2015

Related Keywords:

  • Periampullary Carcinoma Nos
  • Periampullary carcinoma
  • Pancreas-sparing Duodenectomy
  • pancreaticoduodenectomy
  • lymphadenectomy
  • Carcinoma