Suspended

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

What is being tested

Pancreas-sparing duodenectomy

+ Pancreaticoduodenectomy

Procedure

Who is being recruted

From 18 to 80 Years

+14 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: May 2005

See protocol details

Summary

Principal SponsorSouthwest Hospital, China

Study ContactGeng Chen, M.D.,Ph.D.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2005

Actual date on which the first participant was enrolled.

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.

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

NCT01291927

Principal SponsorSouthwest Hospital, China

Study ContactGeng Chen, M.D.,Ph.D.

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

7 inclusion criteria required to participate

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

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7 exclusion criteria prevent from participating

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

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Group II

Active Comparator

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

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

Chongqing, ChinaOpen Institute of Hepatobiliary Surgery, Southwest Hospital,Third Military Medical University in Google Maps

SuspendedOne Study Center